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Cardiac Surgery Clinical Trials

Aortic Disease

The (IRAD) International Registry for Acute Aortic Dissection

Primary Objective: The purpose of this study is to elucidate information about acute aortic dissection patients and disseminate findings through peer-reviewed publications to corroborate clinician behavior and societal guidelines concerning this disease.

Principal Investigator: Leonard Girardi, MD
Contact: Marshagay Rodriques, 212-746-5594
IRB Protocol#: 21-10024019
Status: Active
Patient Accrual: Open to Patient Accrual

Aortic Surgery Clinical Research Database

Primary Objective: The purpose of this study is to obtain patients' clinical data and maintain it in an Aortic Surgery Clinical Research Database used for clinical studies. The study analyzes the risks, teatments, and outcomes of disorders of the thoracic and thoracoabdominal aorta. This research study is being done in order to improve patient treatment options and to better understand the treatment of pathologies of the aorta.

Principal Investigator: Leonard Girardi, MD
ContactMarshagay Rodriques, 212-746-5594
IRB Protocol#: 1607017424
Status: Active
Patient Accrual: Open to Patient Accrual

Cardiac Surgery Biobank

Primary Objective: The Cardiac Surgery Biobank is a repository for vascular tissue, blood and cerebral spinal fluid and will provide a service for doing research using new and emerging technologies. Specimens are banked so that they may be used in future studies.

Principal Investigator: Leonard Girardi, MD
Contact Person: Marshagay Rodriques, 212-746-5594
IRB Protocol#: 1708018519
Status: Active
Patient Accrual: Open to Patient Accrual

MRI for Post Aneurysm Aortic Remodeling

Thoracic aortic aneurysm (TAA) is a serious clinical condition in which the aorta (central blood vessel in the body) abnormally dilates due to intrinsic structural abnormalities in the aortic wall or tensile stress imposed by abnormal blood flow (resulting in vessel wall dilation). Patients with TAA are prone to aortic rupture (dissection), which can result in devastating clinical consequences including death. Surgical aortic grafting can reduce aortic size, and potentially mitigate dissection risk. However, the impact of different surgical techniques (i.e. extent of aortic grafting) on aortic hemodynamics is not known.

Primary Objective: This study will employ state of the art magnetic resonance imaging techniques - including phase velocity encoded flow imaging and vessel wall imaging - to assess aortic hemodynamics prior to and following surgical grafting. MRI will be performed prior to (within 6 months), and following (within 120 months) aortic graft surgery (exact timing of imaging to be determined by clinicians in accordance with clinical standard of care). The primary aim is to evaluate the effect of surgical replacement of portion of the aorta on the remaining native parts in terms of aortic flow, distensibility, size, and wall shear stress. Secondary aims include evaluation of the modification in aortic flow dynamics after replacement of part of the aorta and the prospective assessment of the growth rate of different portions of the aorta in different clinical scenario before and after surgical interventions. To address these aims, primary image analysis will be used to assess aortic flow and distensibility in native aortic segments distal to grafts, for which paired analysis on a per-patient basis will be used to assess physiological changes following surgical grafting. In addition, computational modeling (e.g. finite element analysis and fluid mechanics) will be also be used to assess novel parameters including aortic flow, shear stress, and distensibility.

Principal Investigator: Jonathan Weinsaft, MD
IRB Protocol#: 1511016771
Status: Active
Patient Accrual: Open to Patient Accrual

Evaluation of the Thoraflex Hybrid Device for use in the repair or Replacement of the Ascending Aorta, Aortic Arch, and Descending Aorta in an Open Surgical Procedure (Thoraflex Hybrid IDE study)

Primary Objective:  To assess the effectiveness, safety and clinical outcomes of the Thoraflex™ Hybrid Device in the treatment of aortic disease affecting the aortic arch and the descending thoracic aorta, with or without involvement of ascending aorta.

Principal Investigator: Leonard Girardi, MD
Contact: Marshagay Rodriques, 212-746-5594
ClinicalTrials.gov Identifier: NCT02724072
Status: Active
Patient Accrual: Closed to Patient Accrual

Thoraflex Hybrid and Relay Extension Post-Approval Study (EXTEND)

Primary Objective: To evaluate the Thoraflex Hybrid device alone and in combination with the RelayPro NBS stent-graft in the treatment of aortic disease affecting the aortic arch and descending aorta with or without involvement of the ascending aorta. 

Principal Investigator: Leonard Girardi, MD
Contact: Marshagay Rodriques, 212-746-5594
IRB Protocol #: 23-03025826
Status: Active
Patient Accrual: Open to Patient Accrual

Coronary Artery Disease

Randomized comparison of the clinical Outcome of single versus Multiple Arterial grafts: the ROMA trial

Primary Objective: The primary hypothesis of ROMA is that in patients undergoing primary isolated non-emergent coronary artery bypass surgery (CABG), the use of two or more arterial grafts compared to a single arterial graft is associated with a reduction in the composite outcome of death from any cause, any stroke, post discharge myocardial infarction and/or repeat revascularization. The secondary hypothesis is that in patients undergoing primary isolated non-emergent CABG, the use of two or more arterial grafts compared to a single arterial graft is associated with improved survival. Ancillary studies being conducted in parallel with the ROMA Trial include ROMA Quality of Life, ROMA COG, and ROMA Echo. The aims of these ancillary trials are to determine how CABG patients surgical outcomes are also related to patient Quality of life, cognitive changes over time, and changes to the ROMA trial index CABG’s intraoperative Transesophageal Echo.  

Study Contact: Romatrial@med.cornell.edu 
Contact Website: ROMA Trial
ClinicalTrials.gov Identifier: NCT03217006 
Status: Active
Patient Accrual: Close to Patient Accrual

Canadian CABG or PCI in Patients With Ischemic Cardiomyopathy Trial (STICH3C)

Primary Objective: to determine whether CABG compared to PCI is associated with a reduction in all-cause death, stroke, spontaneous myocardial infarction (MI), urgent repeat revascularization (RR), or heart failure (HF) readmission over a median follow-up of 5 years in patients with multivessel/LM CAD and ischemic left ventricular dysfunction (iLVSD).

Study Contact: stich3c@med.cornell.edu
Trial Website (if applicable): NA
ClinicalTrials.gov Identifier: NCT05427370
Status: Active
Patient Accrual: Open to Patient Accrual

Comparison of the Outcomes of Single vs Multiple Arterial Grafts in Women (ROMA: Women)

Primary Objective: ROMA:Women will leverage the infrastructure and the existing women population of the ROMA trial. ROMA:Women has two key Aims. In Aim 1, the investigators will compare major adverse cardiac and cerebrovascular events (death, stroke, non-procedural myocardial infarction, repeat revascularization and hospital readmission for acute coronary syndrome or heart failure) in a cohort of 2,000 women randomized 1:1 to MAG or SAG (690 from the parent ROMA trial + 1,310 from ROMA:Women). In Aim 2, the investigators will compare generic (SF-12, EQ-5D) and disease-specific (Seattle Angina Questionnaire) QOL and physical and mental health symptoms (PROMIS-29) in a sub-cohort of 500 women randomized 1:1 to MAG or SAG. Differences by important subgroups (patients younger or older than 70 years, diabetics, racial and ethnic minorities, on vs off pump CABG, type of arterial grafts used) will also be evaluated.

Study Contact: Romatrial@med.cornell.edu
Trial Website (if applicable): Roma:Women
ClinicalTrials.gov Identifier: NCT04124120
Status: Active
Patient Accrual: Open to Patient Accrual

Atrial Fibrillation

Prevention of Atrial Fibrillation after Cardiac Surgery (PALACS). 

A prospective randomized clinical trial aimed at evaluating the efficacy of a new method for the prevention of postoperative atrial fibrillation: Posterior left pericardiotomy for the prevention of postoperative atrial fibrillation after cardiac surgery.

Primary Objective: To determine the incidence of Post-Operative Atrial Fibrillation (POAF) after cardiac surgery when posterior pericardiotomy is performed.

Secondary Objectives: To determine the incidence of post-operative pericardial or pleural effusions after cardiac surgery when posterior pericardiotomy is performed.

Principal Investigator: Leonard Girardi, MD
Contact Person: Marshagay Rodriques, 212-746-5594
ClinicalTrials.gov Identifier: NCT02875405
Additional Details: BioMed Central
Status: Active
Patient Accrual: Open to Patient Accrual

AtriCure CryoICE Lesions for Persistent and Long-standing Persistent Atrial Fibrillation Treatment during Concomitant On-Pump Endo/Epicardial Cardiac Surgery

Primary Objective: To evaluate the safety and effectiveness of the AtriCure CryoICE system in performing the Cox-Maze III lesion set, in conjunction with LAA exclusion using the AtriClip device. 

Principal Investigator: Leonard Girardi, MD
Contact Person: Marshagay Rodriques, 212-746-5594
ClinicalTrials.gov Identifier: NCT03732794
Status: Active
Patient Accrual: Open to Patient Accrual

 

Valvular Disease

A Prospective, global study designed to collect real-world clinical outcomes of the MITRIS RESILIA mitral valve - North America (MOMENTIS)

Primary Objective: Collect real-world data on acute and long-term safety and performance of the MITRIS RESILIA Mitral Valve, Model 11400M, in subjects requiring replacement of their native or prosthetic mitral valve with or without concomitant procedures.

Principal Investigator: Leonard Girardi, MD
Contact Person: Marshagay Rodriques, 212-746-5594
ClinicalTrials.gov Identifier: 22-09025314
Status: Active
Patient Accrual: Open to Patient Accrual

A retrospective, multi-center study to evaluate the safety and performance of the Edwards Lifesciences KONECT RESILIA aortic valved conduit (AVC)

Primary Objective: To collect data on the safety and performance of the Edwards Lifesciences KONECT RESILIA aortic valved conduit (AVC) in the treatment of patients who require replacement of their native or prosthetic aortic valve, and the associated repair or replacement of a damaged or diseased ascending aorta.

Principal Investigator: Leonard Girardi, MD
Contact Person: Marshagay Rodriques, 212-746-5594
ClinicalTrials.gov Identifier: 22-09025310
Status: Active
Patient Accrual: Open to Patient Accrual

Bicuspid Aortic Valve Repair with a Valve Sparing Reimplantation technique in a Gelweave Valsalva Graft: a Multicenter Retrospective Study (UNITED Trial)

Primary Objective: We propose to perform a retrospective chart review for a multicenter study with a large cohort of BAV patients undergoing a valve sparing reimplantation technique with the Gelweave™ Valsalva graft from 2002 - 2020.

Principal Investigator: Leonard Girardi, MD
Contact: Marshagay Rodriques, 212-746-5594
IRB Protocol#: 22-01024351
Status: Active
Patient Accrual: Open to Patient Accrual

Percutaneous or Surgical Repair in Mitral Prolapse and Regurgitation for > 65 Year-Olds (PRIMARY)

Primary Objective:  The primary aim of this study is to evaluate the long-term effectiveness and safety of MV TEER (percutaneous clip repair) compared with surgical repair in patients with primary, degenerative MR.

Secondary Objective: The secondary aim is to analyze the relationship between the adequacy of MR correction at one-year post randomization and longer-term clinical outcomes (death, heart failure hospitalizations/urgent care visits, valve re-interventions, and quality of life).

Contact: Stephanie L. Mick, MD (Cardiac Surgery), Mark Reisman (Interventional Cardiology)
Clinical Trials.Gov Identifier: NCT05051033
Status: Active
Patient Accrual: Open to Patient Accrual

Prospective Non-Randomized Single Arm Multi-Center Evaluation Of The Durability Of Aortic Bioprostheses/Valves With RESILIA Tissue In Subjects Under 65 (RESILIENCE Trial)

Primary Objective: To determine time to valve failure due to valve deterioration requiring re-intervention and collect/investigate early potential predictors of valve durability (e.g., calcification and hemodynamic deterioration) in RESILIA tissue valves.

Principal Investigator: Leonard Girardi, MD
Contact Person: Marshagay Rodriques, 212-746-5594
ClinicalTrials.gov Identifier: NCT03680040
Status: Active
Patient Accrual: Open to Patient Accrual

The PARTNER III

A Prospective, Randomized, Controlled, Multi-Center Study to Establish the Safety and Effectiveness of the SAPIEN 3 Transcatheter Heart Valve in Low Risk Patients who have Severe, Calcific, Aortic Stenosis Requiring Aortic Valve replacement

Primary Objective: The purpose of this trial is to establish the safety and efficacy of the Edwards SAPIEN 3 THV device in patients with severe, calcific, aortic stenosis who are at low operative risk for SAVR.

Secondary Objectives: CT Sub-Study: The purpose of the study is to investigate the prevalence of the imaging abnormality.

Principal Investigator: Stephanie Mick, MD and S. Chiu Wong, MD
Contact Person:William Acquavella Heart Valve Center, (646)697-8258
Contact Site: William Acquavella Heart Valve Center
ClinicalTrials.gov Identifier: NCT02675114
Status: Active
Patient Accrual: Open To Patient Accrual

PORTICO Trial  Portico Re-sheathable Transcatheter Aortic Valve System US IDE Trial

Primary Objective: The PORTICO clinical trial is designed to evaluate the safety and effectiveness of the SJM Portico Transcatheter Heart Valve and Delivery Systems (Portico) via transfemoral and alternative delivery methods.

Secondary Objectives: Objective for Version K: Enrollment of randomized subjects in the Portico IDE study is anticipated to be completed in September/October 2017. Conduct of the CAP will follow the pivotal IDE study

Principal Investigator:  Stephanie L. Mick, MD and S. Chiu Wong, MD
Contact:William Acquavella Heart Valve Center, (646) 697-8258
Contact WebSite: William Acquavella Heart Valve Center
ClinicalTrials.gov Identifier: NCT02000115
Status: Active
Patient Accrual: Open To Patient Accrual

Clinical Trial To Evaluate The Safety And Effectiveness Of Using The Tendyne Mitral Valve System For The Treatment Of Symptomatic Mitral Regurgitation (SUMMIT Trial)

Primary Objective: To evaluate the safety and effectiveness of the Tendyne Mitral Valve System for the treatment of patients with symptomatic, moderate-tosevere or severe mitral regurgitation or for patients with symptomatic mitral valve disease due to severe mitral annular calcification.

Principal Investigator: Stephanie L. Mick, MD
Contact Person: Marshagay Rodriques, 212-746-5594
ClinicalTrials.gov Identifier: NCT03433274
Status: Active
Patient Accrual: Open to Patient Accrual

Validation of a personal fitness tracker as a predictor and motivational tool in cardiac surgery

Primary Objective: The use of wearable personal fitness monitors (WPFMs) in risk assessment and as recuperation aids in minimally invasive cardiac surgery (e.g., transcatheter aortic valve replacement (TAVR)) are novel concepts and largely unreported in the literature. Hence, this study may potentially help to create new paradigms for cardiac surgery patient selection and postoperative recovery. 

Principal Investigator: Stephanie Mick, MD
Contact: Adham Elmously MD, (212) 746-6707
IRB Protocol#: 1710018685
Status: Pending
Patient Accrual: Pending

THE PARTNER II  Placement of AoRTic TraNscathetER Valve Trial

Primary Objective: This clinical trial is for men and women who are diagnosed with severe aortic stenosis and are at intermediate-risk for traditional open-heart surgery for aortic valve replacement.  

The purpose of the study is to assess the safety and effectiveness of the SAPIEN XT and SAPIEN 3 transcatheter heart valves. Unlike traditional replacement aortic valves, they are implanted with a catheter procedure to eliminate the need for surgery.  These devices are approved by FDA for patients who are at high-risk for traditional open-heart surgery.

Study subjects will be followed up for 5 years after placement of the stent.

Principal Investigator: Stephanie Mick, MD and S. Chiu Wong, MD
Contact Person: William Acquavella Heart Valve Center, (646) 697-8258
Contact Site: William Acquavella Heart Valve Center
ClinicalTrials.gov Identifier: NCT01314313
Status: Active
Patient Accrual: Closed to Patient Accrual

Clinical Investigation of the Perceval S Sutureless Heart Valve 

Primary Objective: To demonstrate the safety and effectiveness of the Perceval S heart valve when used to replace a diseased or dysfunctional aortic valve or aortic valve prosthesis.

This investigation is a prospective, non-randomized, multi-center trial of the PERCEVAL valve implanted in patients requiring aortic valve replacement. The study will be conducted in a maximum of 25 centers in the United States. Patients will be evaluated at each of the following time intervals:preoperative, at implant, in the early postoperative period, in the late postoperative period (between 3 and 6 months postoperatively), at 1 year (between 11 and 13 months postoperatively), and annually until study completion. The duration of the study is anticipated to be 5 years.

Principal Investigator: Leonard Girardi MD
ContactMarshagay Rodriques, 212-746-5594
ClinicalTrials.Gov Identifier: NCT01810679
Status: Active
Patient Accrual: Closed to Patient Accrual

Prospective, Non-Randomized, Multicenter Clinical evaluation of the Edwards Pericardial Aortic & Mitral Bioprostheses (Models 11000A & 11000M) with a new tissue treatment platform (COMMENCE TRIAL)

Primary Objective:  The objective of this trial is to confirm that the modifications to tissue processing, valve sterilization and packaging do not raise any new questions of safety and effectiveness in subjects who require replacement of their native or prosthetic aortic or mitral valve.

Multicenter, prospective, single arm trial - Up to seven hundred (700) aortic valve replacement (AVR) subjects and up to one hundred seventy-five (175) mitral valve replacement (MVR) subjects at up to forty (40) clinical sites will be enrolled. The trial will include male and female patients, 18 years or older, requiring replacement for a diseased, damaged, or malfunctioning native or prosthetic aortic or mitral valve. Patients will be followed and assessed after implant for up to 5 years.

Principal Investigator: Leonard Girardi, MD
Contact: Marshagay Rodriques, 212-746-5594
ClinicalTrials.Gov Identifier: NCT01757665
Status: Active
Patient Accrual:
Closed to Patient Accrual

Aortic Valve Operative Outcomes In Marfan Patients. (AVOMP)

Primary Objective:  To evaluate and compare operative outcomes of the aortic-valve sparing and aortic valve replacement surgical interventions in different categories of the patients with Marfan Syndrome and estimate the predictors of the surgical outcomes.

Principal Investigator: Leonard N. Girardi, MD
Contact Person: Marshagay Rodriques, 212-746-5594
IRB Protocol#: 408007398
Status: Active
Patient Accrual: Closed to Patient Accrual

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Phone: (212) 746-5166