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
| Arm | Description | Assigned 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
Massachusetts General Hospital
Boston, Massachusetts 02144
Boston, Massachusetts 02144
More Details
- Status
- Recruiting
- Sponsor
- Impulse Dynamics
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.