CCM OPEN HF Registry

Impulse Dynamics

Status: Enrolling

Conditions: Heart Failure

Study type: Observational

Funder types: Industry

Identifiers

NCT07112924

OPEN_CA_CP_2025

Details and patient eligibility

About

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

Full 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.

Enrollment: 5,500 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

5,500 participants in 3 patient groups

Retrospective Cohort

Description:

Prospective Cohort

Hybrid (Retrospective-Prospective) Cohort

Description:

Patients who will receive/ have received CCM therapy with an Impulse Dynamics devices

Prospective Cohort

Description:

Patients who will receive CCM therapy with an Impulse Dynamics devices