Recruiting

CCM Therapy

Sponsor:

Impulse Dynamics

Code:

NCT07112924

Conditions

Heart Failure

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Study Details

Brief summary:

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

Conditions

Heart Failure

Study ID

NCT07112924

Start date

Nov 1, 2025

Status verified date

Apr, 2026

Completion date

Aug 1, 2036

Anticipated

Primary completion date

Aug 15, 2035

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

5500 participants

Anticipated

Interventions and Outcome Measures

Arms

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

Primary outcome measure

  • Assess CCM's effect on the rate and length of stay of heart failure (HF) hospitalizations [ Time Frame: 1 Year ]
  • Demonstrate the long-term safety of CCM therapy in a real-world setting, by assessing the rate of device- or procedure-related complications. [ Time Frame: 5 Years ]

Central Contacts and Locations

Central contacts

Karl Van Wygerden

856-642-9933kvanwygerden@impulsedynamics.com

Erika Mednick

8454990412emednick@impulsedynamics.com

Locations

Cardiovascular Associates of Mesa

Recruiting

Mesa, Arizona, United States, 85206

Contacts

Adam Gitkin, MS

480-641-5400agitkin@cvam.com

Principal Investigator:

Ambrose Panico, DO

Peak Heart and Vascular

Recruiting

Surprise, Arizona, United States, 85378

Contacts

Tasha Marriott

tasha.marriott@axsendoclinical.com

Principal Investigator:

Andy Tran, MD

Massachusetts General Hospital

Recruiting

Boston, Massachusetts, United States, 02144

Contacts

Payton Black

617-643-1972pblack3@mgh.harvard.edu

Chris Azzam

617-643-9621cazzam@mgh.harvard.edu

Principal Investigator:

Theofanie Mela, MD

The Stern Cardiovascular Foundation, Inc

Recruiting

Germantown, Tennessee, United States, 38138

Contacts

Kari Fondren

901-271-4062kari.fondren@sterncardio.com

Principal Investigator:

Steven Gubin, MD

David Turbay, MD

Recruiting

El Paso, Texas, United States, 79905

Contacts

Ricardo Pulido

915-600-2190rpulido@davidturbaymd.com

Principal Investigator:

David Turbay, MD

Centra Health, Inc. dba Stroobants Cardiovascular Center

Recruiting

Lynchburg, Virginia, United States, 24501

Contacts

Cindy Baumann

434-200-2727cindy.baumann@centrahealth.com

Principal Investigator:

Matthew Sackett, MD

More Information

Sponsor

Impulse Dynamics

Last update posted

Apr 23, 2026

Last verified

Apr, 2026

Keywords

  • Heart Failure
  • CCM
  • Optimizer
  • Implantable Pulse Generator
  • FDA Approved
  • Heart Failure Hospitalization
  • Ischemic vs non-ischemic
  • CRT non-responders
  • Patients with concomitant devices
  • Patients with wide, intermediate, narrow QRS
  • Patients with cardiac amyloidosis

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Impulse Dynamics on 2026-04-23.