CCM OPEN HF Registry

Purpose

The registry has been designed to evaluate the long-term safety and efficacy of CCM therapy in a real-world setting.

Condition

  • Heart Failure

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Patients who have /will be implanted with Impulse Dynamics CCM technologies (e.g. CCM or CCM-D when available) as determined by investigators - Willing and able to provide informed consent, including for use of data for research purposes (e.g. publication, sub-studies/sub-analyses)

Exclusion Criteria

  • Noncompliant patients (e.g. for follow-up visits, medication, etc.) as determined by investigators. - Subjects with a mechanical tricuspid valve

Study Design

Phase
Study Type
Observational [Patient Registry]
Observational Model
Cohort
Time Perspective
Cross-Sectional

Arm Groups

ArmDescriptionAssigned Intervention
Retrospective Cohort Prospective Cohort
Hybrid (Retrospective-Prospective) Cohort Patients who will receive/ have received CCM therapy with an Impulse Dynamics devices
Prospective Cohort Patients who will receive CCM therapy with an Impulse Dynamics devices

Recruiting Locations

Cardiovascular Associates of Mesa
Mesa, Arizona 85206
Contact:
Adam Gitkin, MS
480-641-5400
agitkin@cvam.com

Peak Heart and Vascular
Surprise, Arizona 85378
Contact:
Tasha Marriott
tasha.marriott@axsendoclinical.com

Massachusetts General Hospital
Boston, Massachusetts 02144
Contact:
Payton Black
617-643-1972
pblack3@mgh.harvard.edu

The Stern Cardiovascular Foundation, Inc
Germantown, Tennessee 38138
Contact:
Kari Fondren
901-271-4062
kari.fondren@sterncardio.com

David Turbay, MD
El Paso, Texas 79905
Contact:
Ricardo Pulido
915-600-2190
rpulido@davidturbaymd.com

Centra Health, Inc. dba Stroobants Cardiovascular Center
Lynchburg, Virginia 24501
Contact:
Cindy Baumann
434-200-2727
cindy.baumann@centrahealth.com

More Details

Status
Recruiting
Sponsor
Impulse Dynamics

Study Contact

Karl Van Wygerden
856-642-9933
kvanwygerden@impulsedynamics.com

Detailed Description

This is a global, prospective and retrospective, multicenter, single-arm, observational study intended to include patients who will receive/have received CCM therapy with an Impulse Dynamics system, including future CCM technologies (e.g. CCM-D), for a follow-up period of at least 5 years.