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.

Valve Disease Clinical Trials

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

Arrhythmia Clinical Trials

ProMRI Study of the Entovis Pacemaker System

Sponsor: Biotronik, Inc.

Intervention: Device: ProMRI Pacemaker System for Bradycardia (Slow Heart Beat).

Other: Magnetic Resonance Imaging (MRI) scan of head and lower back.

Purpose of Study: The objective of the ProMRI Study is to demonstrate the clinical safety of the ProMRI Pacemaker System when used under specific MRI conditions.

Study Description: This is an observational study of 245 subjects; selection for participation should be from the investigators' general patient population according to the inclusion and exclusion criteria. Implanted with a pacemaker system consisting only of an Entovis pacemaker (DR-T, SR-T) and one or two Setrox S 53 or Setrox S 60 pacemaker lead(s). (No leads other than Setrox S (53 or 60 cm) leads may be implanted. This includes lead extensions or abandoned leads in the subject.) All pacemaker system components implanted, repositioned, or exchanged at least 5 weeks prior to enrollment.

Subjects must be able and willing to:

  • Complete MRI testing
  • Provide written informed consent
  • Available for follow-up visit at the study site
  • Baseline Evaluation
  • MRI procedure
  • One Month Follow-up (post MRI)
  • Three Month Follow-up (post MRI)

For more information, go to www.ClinicalTrials.gov

ClinicalTrials.gov Identifier: NCT01761162

Pacing Clinical Trials

The LEADLESS II Study

Sponsor: St.Jude Medical

Intervention:

Device: Leadless Pacemaker

Purpose of Study: The purpose of this research study is to evaluate the safety and effectiveness of the leadless pacemaker system in treating patients with a slow heart rate or irregular heartbeats. This Investigational Device Exemption (IDE) study is a prospective, non-randomized, single-arm, international multicenter, clinical safety and effectiveness investigation.

Study Description: This is an interventional study that will be conducted at a maximum of 50 investigational centers located in the U.S. A maximum of 667 patients implanted with the Leadless Pacemaker will be enrolled in the study. The implanted leadless pacemaker is intended to help reduce certain complications associated with traditional pacemakers and leads.

Subjects must be able and willing to:

  • Receive a new Pacemaker implant
  • Provide written informed consent
  • Available for follow-up visits, required tests and exams at the study site at:
    • Baseline Evaluation
    • Implant Procedure
    • 2 week, 6 week, 3 month, 6 month
    • Every 6 months after until study completion and then every year for 7 years post implant

For more information, go to www.ClinicalTrials.gov

ClinicalTrials.gov Identifier: NCT02030418

Or contact

Study Research Coordinators:

Amy Perez, RN or Michaela Toney, RN

949-764-4509 / 949-764-4510

amy.perez@hoag.org

michaela.toney@hoag.org

Hoag Memorial Hospital Presbyterian

MultiPoint™ Pacing IDE Study (MPP IDE)

Sponsor: St.Jude Medical

Intervention:

Device: CRT-D, MultiPoint™ Pacing (MPP)

Purpose of Study: This IDE study is a prospective, randomized, double-blind, multi-center clinical study to evaluate the safety and efficacy of patient treatment with MPP compared to patient treatment with standard BiV pacing at 9 months.

Study Description: This is an interventional study that will be conducted at a maximum of 50 investigational centers located in the U.S. A maximum of 506 patients implanted with the Quadripolar CRT-D device system will be enrolled in the study.

Subjects must be able and willing to:

  • Receive a new CRT implant
  • Provide written informed consent
  • Available for follow-up visit at the study site
  • Baseline Evaluation
  • Implant Procedure
  • 3, 6, 9 month follow-up visits
  • Every 6 months after until study completion

For more information, go to www.ClinicalTrials.gov

ClinicalTrials.gov Identifier: NCT01786993