CCM OPEN HF Registry

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

5500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-11-01

Study Completion Date

2036-08-01

Brief Summary

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

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Detailed Description

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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.

Conditions

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Heart Failure

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Retrospective Cohort

Prospective Cohort

No interventions assigned to this group

Hybrid (Retrospective-Prospective) Cohort

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

No interventions assigned to this group

Prospective Cohort

Patients who will receive CCM therapy with an Impulse Dynamics devices

No interventions assigned to this group

Eligibility Criteria

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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)