Paracor Ventricular Support System (PVSS) for Patients With Heart Failure

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

39 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-01-31

Study Completion Date

2011-04-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This is a limited safety and feasibility study to evaluate the PVSS Introducer and Paracor Ventricular Support System when used to treat patients with heart failure. The implant, which is loaded onto the delivery system, is placed over the epicardial surface of the right and left ventricles.

No formal hypothesis testing will be performed; descriptive statistics will be used to summarize patient outcomes. The results of the study will be used to guide the design and sample size estimation of future studies.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Prospective Evaluation of Elastic Restraint to LESSen the Effects of Heart Failure (PEERLESS-HF) Trial

NCT00382863

Heart Failure

TERMINATED PHASE2/PHASE3

BiVACOR® Total Artificial Heart Early Feasibility Study

NCT06174103

Heart Failure Biventricular Failure

RECRUITING NA

VentrAssistTM LVAD as a Bridge to Cardiac Transplantation - Feasibility Trial

NCT00490347

End-Stage Heart Failure Cardiomyopathies

COMPLETED PHASE2

Safety and Efficacy Study of the PTMA Device to Reduce Mitral Valve Regurgitation in Patients With Heart Failure

NCT00815386

Mitral Regurgitation Heart Failure

SUSPENDED PHASE2/PHASE3

Registry for Cardiogenic Shock: Utility and Efficacy of Device Therapy

NCT02790242

Heart Failure Cardiogenic Shock

TERMINATED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Please refer to brief summary.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Heart Failure, Congestive

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Placement of the PVSS Implant

Implant is placed on epicardial surface of the heart surrounding both the right and left ventricles, to provide mechanical support to the ventricular walls.

Intervention Type DEVICE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

HeartNet Ventricular support device Ventricular elastic support therapy

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* NYHA functional class II or III
* Best medical therapy
* Ejection fraction \<= 35%

Exclusion Criteria

* Heart measurements too large or small for implant sizes
* Intra-cardiac thrombus
* Restrictive cardiomyopathy
* Not a candidate for sternotomy
* Expected adhesions
* Previous coronary artery bypass graft (CABG)
* Active infection
* Stroke, surgery, or implantable cardioverter defibrillator (ICD) within 3 months
* Myocardial infarction (MI) within 1 month

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No