Cardiothoracic Surgery

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Cardiac Surgery Clinical Trials

Aortic Disease

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
Contact: Nathan Palaparthi, (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: Nathan Palaparthi, (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: Nathan Palaparthi, (212) 746-5594
ClinicalTrials.gov Identifier: NCT02724072
Status: Active
Patient Accrual: Closed to Patient Accrual

 

Coronary Artery Disease

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.

Prospective event-driven unblinded randomized multicenter trial of at least 4,300 subjects enrolled in at least 25 international centers. Patients will be randomized to a single arterial graft (SAG) or multiple arterial grafts (MAG). Patients will be randomized in a 1:1 fashion between the two groups. Permuted block randomization with random blocks stratified by the center and the type of second arterial graft will be used to provide treatment distribution in equal proportion.

Principal Investigator: Mario Gaudino, MD
Contact: Nathan Palaparthi, (212)746-5594
Contact Website: ROMA
ClinicalTrials.gov Identifier: NCT03217006
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: Nathan Palaparthi, (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: Nathan Palaparthi, (212)746-5594
ClinicalTrials.gov Identifier: NCT03732794
Status: Active
Patient Accrual: Open to Patient Accrual

Valvular Disease

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: Nathan Palaparthi, (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: Arash Salemi, 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: Nathan Palaparthi, (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
Contact: Nathan Palaparthi, (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: Nathan Palaparthi, (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: Nathan Palaparthi, (212)746-5594
IRB Protocol#: 408007398
Status: Active
Patient Accrual: Closed to Patient Accrual

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Phone: (212) 746-5166