Heart Valves Clinical Trials
Cedars-Sinai Heart Institute is currently conducting the following heart valve clinical trials:
• Percutaneous Aortic Valve Implantation –the SAPIEN™ Transcatheter Heart Valve (THV) - in Aortic Stenosis - Partner Trial
• EVALVE EVEREST II: Mitral Valve Clip for Patients with Severe Mitral Regurgitation
• Implantation of the SAPIEN™ Transcatheter Heart Valve (THV) in the Pulmonic Position “Compassion” Study
Percutaneous Aortic Valve Implantation –the SAPIEN™ Transcatheter Heart Valve (THV)- in Aortic Stenosis - Partner Trial
Principal Investigator(s): Rajendra Makkar, MD; Greg Fontana, MD
IRB Approval Number: 12966
Contact: Mitch Gheorghiu (310) 423-6152
Summary: Symptomatic patients with severe aortic stenosis will be considered for this study. Patients with high risk but operable (Group A) will undergo either (1:1 chance) Aortic Valve Replacement (AVR) surgery or Transcatheter Heart Valve implantation (THV). The objective for this group is to demonstrate that valve implantation procedure (THV) is non-inferior to the gold standard open heart surgery (AVR). Patients considered with even higher risk (non-operable) Group B, will undergo either (1:1 chance) Transcatheter Heart Valve implantation or best medical treatment. The objective for this group is to demonstrate that valve implantation procedure is superior to best medical treatment. Implantation of the transcatheter heart valve may result in improved valvular function, acute alleviation of symptoms and improved morbidity and mortality.
At the moment, the Trial is in the “Continued Access” phase, in which all suitable patients (operable and non-operable) will have the aortic valve replacement through the Transcatheter procedure.
Principal Investigator: Saibal Kar, MD
IRB Approval Number: 6381
Contact: Simmy Shirazi (310) 248-6673 or Diana Remba (310) 423-6586
Summary: The purpose of this study is to evaluate and monitor the safety and effectiveness of an endovascular approach to the treatment of the mitral valve regurgitation using Evalve Cardiovascular Valve Repair System.
Mitral valve regurgitation (MR) occurs when the two leaflets of the mitral valve do not close properly. This device consists of a delivery catheter and an implantable Clip ( called the MitraClip device ). The delivery catheter guides the MitraClip device into place so that it can be attached to the leaflets of the mitral valve. This procedure is performed using TEE and fluoroscopy under general anaesthesia in the catheterization laboratory.
MitraClip is manufactured and sponsored by Evalve, Inc. The study is powered to show superiority of safety of an endovascular treatment strategy with the Clip as compared to the treatment strategy of mitral valve repair or replacement surgery.
Implantation of the SAPIEN™ Transcatheter Heart Valve (THV) in the Pulmonic Position “Compassion” Study
Principal Investigator: Raj Makkar, MD
IRB Approval Number: 17547
Contact: Mitch Gheorghiu (310) 423-6152
Summary: This is a non-randomized, feasibility, multi center study, evaluating safety and effectiveness of pulmonary transcatheter heart valve (Edwards SAPIEN THV) implantation (the study investigational device/procedure) in subjects with diseased conduit between the right ventricle and pulmonary artery. These patients require treatment for moderate or severe pulmonic valve regurgitation (PR – backflow of blood) insufficiency. The implantation of the THV does not require open-heart surgery and can be done in a catheterization laboratory (as used for balloon angioplasty procedures). This procedure uses the transfemoral approach (through the leg) and will be performed under local and/or general anesthesia, using fluoroscopy (x-rays) for visualization.
The Primary End Point of the study: freedom from device or procedure related death and/or reoperation at 1 year. The Secondary End Points are: freedom from death, stroke, MI, vascular injury, pulmonary embolism, at 6 months,
as well as assessment of functional improvement (decrease of pulmonic regurgitation). It has been shown that pulmonary valve replacement may decrease the incidence of atrial and ventricular arrhythmias as well.