Clinical Research Studies at Jeffrey M. Carlton Heart & Vascular Institute

The Jeffrey M. Carlton Heart and Vascular Institute is committed to supporting clinical research which complements our patient care initiatives.

Clinical Research at the Jeffrey M. Carlton Heart and Vascular Institute is supported by Hoag’s Institute for Research & Education (HIRE) and includes various industry sponsored studies which include both drug and medical devices. Major areas of focus include cardiac imaging studies, techniques for testing and programming implantable cardiac defibrillators/pacemakers and cardiac valve surgery.

For more information about our Cardiovascular Clinical Trials, please contact the research coordinators Amy Perez at 949-764-4509 or Michaela Toney 949-764-4510.

The Safety and Effectiveness of the SAPIEN 3 Transcatheter Heart Valve in Low Risk Patients With Aortic Stenosis (PARTNER 3)

Study Title: A Prospective, Randomized, Controlled, Multi-Center Study to Establish the Safety and Effectiveness of the SAPIEN 3 Transcatheter Heart Valve in Low Risk Patients Requiring Aortic Valve Replacement Who Have Severe, Calcific, Symptomatic Aortic Stenosis

Sponsor: Edwards Lifesciences

Intervention: Device: Edwards SAPIEN 3 THV

Purpose of Study: To establish the safety and effectiveness of the Edwards SAPIEN 3 Transcatheter Heart Valve in patients with severe, symptomatic aortic stenosis who are at low operative risk for standard aortic valve replacement (AVR).

Click here for more information.

Or contact

Wendy Price, BSN, RN
Study Research Coordinator
Office: 949-764-4510
[email protected]
Hoag Memorial Hospital Presbyterian

Kathy Binder, RN
Study Research Coordinator
Office: 949-764-4509
[email protected]
Hoag Memorial Hospital Presbyterian

Surgical Treatment of Aortic Stenosis With a Next Generation, Rapid Deployment Surgical Aortic Valve (TRANSFORM™)

Sponsor: Edwards Lifesciences

Intervention: Surgical replacement of the aortic valve with the EDWARDS INTUITY valve.

Purpose of Study: The purpose of the clinical study is to prove that the heart valve device is safe, effective, and performs as intended.

Study Description: This is a prospective, non-randomized, multi-center trial. Up to 650 subjects will be enrolled at up to 25 centers in the US. After re-placement of their aortic heart valve with the EDWARDS INTUITY valve system, each patient will have routine follow-up tests at the following intervals: discharge, 3 months, 1 year, and annually there-after for a minimum of five years.

Primary Outcome Measures: Long term Performance: Clinically acceptable function by echocardiogram: Time Frame: All subjects will be assessed for clinical follow-up at the following intervals: Discharge, 1 mo., 3 mo., 1 yr and annually thereafter thru 5 yr follow-up per subject. The safety endpoints consist of mortality, valve thrombosis, thromboembolism, hemorrhage, paravalvular leak, endocarditis, structural and non-structural valve deterioration, explant, hemolysis, re-operation, and implant related new or worsening of a cardiac conduction issue.

For more information, go to www.ClinicalTrials.gov

ClinicalTrials.gov Study Identifier: NCT01700439