Heart Failure Clinical Trial
Official title:
Clinical Evaluation of Acorn CorCap Cardiac Support Device Concomitant to MVR - A Confirmatory Trial
The purpose of this study to evaluate patients when they have an Acorn CorCapTM Cardiac
Support Device (CSD) placed around their heart for the treatment of heart failure at the
same time as their mitral valve surgery.
The CorCapTM CSD is intended to support the heart, potentially preventing further dilation
that is associated with progressive heart failure, thereby potentially preserving or
improving heart function.
The Acorn CorCap Cardiac Support Device (CSD) is a new therapy for the treatment of heart
failure that is designed to reduce left ventricular dilation, which is one of the most
important pathophysiological mechanisms underlying the clinical syndrome of heart failure.
The Acorn CorCap CSD is intended to reduce wall stress and support the heart, in order to
prevent further dilation that is associated with progressive heart failure. It is designed
to result in reduced left ventricular size and improve left ventricluar function, which
should result in improved patient functional status.
The purpose of the study is to provide confirmatory data to demonstrate an improved
benefit-risk profile in support of a Pre-Market Approval (PMA) application for the Acorn
CorCap CSD when placed concomitant to Mitral Valve Repair/Replacement (MVR).
The primary efficacy objective is to evaluate patient functional status after 6 months of
follow-up. The safety endpoint is perioperative (30 day) mortality.
;
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT05654272 -
Development of CIRC Technologies
|
||
| Recruiting |
NCT05196659 -
Collaborative Quality Improvement (C-QIP) Study
|
N/A | |
| Recruiting |
NCT05650307 -
CV Imaging of Metabolic Interventions
|
||
| Active, not recruiting |
NCT05896904 -
Clinical Comparison of Patients With Transthyretin Cardiac Amyloidosis and Patients With Heart Failure With Reduced Ejection Fraction
|
N/A | |
| Completed |
NCT05077293 -
Building Electronic Tools To Enhance and Reinforce Cardiovascular Recommendations - Heart Failure
|
||
| Recruiting |
NCT05631275 -
The Role of Bioimpedance Analysis in Patients With Chronic Heart Failure and Systolic Ventricular Dysfunction
|
||
| Enrolling by invitation |
NCT05564572 -
Randomized Implementation of Routine Patient-Reported Health Status Assessment Among Heart Failure Patients in Stanford Cardiology
|
N/A | |
| Enrolling by invitation |
NCT05009706 -
Self-care in Older Frail Persons With Heart Failure Intervention
|
N/A | |
| Recruiting |
NCT04177199 -
What is the Workload Burden Associated With Using the Triage HF+ Care Pathway?
|
||
| Terminated |
NCT03615469 -
Building Strength Through Rehabilitation for Heart Failure Patients (BISTRO-STUDY)
|
N/A | |
| Recruiting |
NCT06340048 -
Epicardial Injection of hiPSC-CMs to Treat Severe Chronic Ischemic Heart Failure
|
Phase 1/Phase 2 | |
| Recruiting |
NCT05679713 -
Next-generation, Integrative, and Personalized Risk Assessment to Prevent Recurrent Heart Failure Events: the ORACLE Study
|
||
| Completed |
NCT04254328 -
The Effectiveness of Nintendo Wii Fit and Inspiratory Muscle Training in Older Patients With Heart Failure
|
N/A | |
| Completed |
NCT03549169 -
Decision Making for the Management the Symptoms in Adults of Heart Failure
|
N/A | |
| Recruiting |
NCT05572814 -
Transform: Teaching, Technology, and Teams
|
N/A | |
| Enrolling by invitation |
NCT05538611 -
Effect Evaluation of Chain Quality Control Management on Patients With Heart Failure
|
||
| Recruiting |
NCT04262830 -
Cancer Therapy Effects on the Heart
|
||
| Completed |
NCT06026683 -
Conduction System Stimulation to Avoid Left Ventricle Dysfunction
|
N/A | |
| Withdrawn |
NCT03091998 -
Subcu Administration of CD-NP in Heart Failure Patients With Left Ventricular Assist Device Support
|
Phase 1 | |
| Recruiting |
NCT05564689 -
Absolute Coronary Flow in Patients With Heart Failure With Reduced Ejection Fraction and Left Bundle Branch Block With Cardiac Resynchronization Therapy
|