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NCT Number: NCT07112924

CCM OPEN HF Registry

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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Key information

Conditions

Heart Failure Cardiovascular Diseases Heart Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Cardiovascular Associates of Mesa, Mesa, Arizona, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Assess CCM's effect on the rate and length of stay of heart failure (HF) hospitalizations

    Time frame: 1 Year

    Change in the HF hospitalization / urgent HF visit rate and hospital length of stay from 1 year prior to 1 year following index implantation.

  2. 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

    Rate of freedom from a composite of device- or procedure-related complication post-index implantation procedure.

    Serious procedure related complications occurring through the end of 30 days following the index procedure.

    Serious CCM device-related complications* occurring through the end of 1-year following the index procedure.

    • excluding lead-related complications

Secondary outcomes

  1. Assess CCM's effect on clinical outcomes

    Time frame: 5 Years

    Composite of all-cause mortality, heart-failure hospitalizations/urgent heart failure visits, progression to LVAD/heart transplant 1-, 3-, and 5-years following the index procedure.

  2. Assess CCM's effect on mortality (all-cause, cardiovascular, and heart failure related)

    Time frame: 5 Year

    All-cause: Observed mortality will be compared to predicted mortality for the subject group according to the Seattle Heart Failure Model (SHFM) and/or Meta-analysis Global Group in Chronic Heart Failure (MAGGIC) at 1-, 3-, and 5-years following the index procedure.

    Cardiovascular related mortality will be assessed at 1-, 3-, and 5-years following the index procedure.

  3. Assess CCM's effect on healthy days at home (HDAH)

    Time frame: 3 Years

    Assessment of HDAH 1 year prior to 3 years following index implantation.

  4. Assess CCM's effect on functional capacity

    Time frame: 5 Year

    Change in NYHA Functional Class from baseline to 1-, 2-, 3-, 4-, and 5-years following the index procedure.

    Change in 6-minute walk test (6MWT) from baseline to 1 year following the index procedure.

  5. Kansas City Cardiomyopathy Questionnaire (KCCQ)

    Time frame: 1 Year

    Change in KCCQ score from baseline to 6 months and 1 year after the index procedure. Scores range from 0 to 100, with higher scores showing better health status and lower scores showing worsen health status.

  6. Assess CCM's effect cardiovascular reverse remodeling

    Time frame: 5 Year

    Change in LVEF, LVESV, LVEDV from baseline to 1-, 2-, 3-, 4-, and 5-years following the index procedure.

  7. Assess CCM's effect QRS duration

    Time frame: 5 Years

    Change in QRS duration from baseline to 1-, 2-, 3-, 4-, and 5-years following the index procedure.

  8. Assess CCM's systemic effects

    Time frame: 5 Years

    Change in eGFR and BNP from baseline to 1-, 2-, 3-, 4-, and 5-years following the index procedure.

  9. Assess long-term CCM device-related adverse events and lead related events

    Time frame: 5 Years

    An assessment of the incidence of CCM device-related serious complications and non-serious CCM-device-related observations occurring during the 5-year period following the index procedure.

  10. Assess the dose response of CCM therapy

    Time frame: 5 Year

    Correlation of CCM % and milliamp (mA) delivered with clinical outcomes and health status

  11. Evaluate subject battery charging compliance

    Time frame: 5 Year

    Assess overall battery charging compliance defined as 60 minutes of charging per 10-day period between charging sessions (Expressed as percentage of compliant charging periods per subject over time e.g., number of compliant charging cycles ÷ total expected cycles × 100%).

  12. Assess the effect of ancillary equipment on clinical outcomes

    Time frame: 5 Years

    Impact of ancillary equipment on clinical outcomes at 1- 2-, 3-, 4-, and 5-years following the index procedure. Including but not limited to:

    Lead type: style-driven lead, lumenless lead

    Guiding sheath/catheter

  13. Assess CCM clinical outcomes by subject sub-groups

    Time frame: 5 Years

    Assess CCM effectiveness at various timepoints in sub-groups of interest, including but not limited to:

    Male vs female <65 vs ≥ 65-year-old Ischemic vs non-ischemic CRT non-responders Patients with concomitant devices (e.g. CRT, pacemaker, LBBP) Patients with wide, intermediate, narrow QRS Patients with cardiac amyloidosis

Study contacts

Contact information is provided by the study sponsor or research team.

Erika Mednick

CONTACT

[email protected]

8454990412

Karl Van Wygerden

CONTACT

[email protected]

856-642-9933

Sponsors and collaborators

Lead sponsor

Impulse Dynamics

Industry

Registry information

Official study title

CCM Technologies OPEN HF Registry: Observational Patient EvaluatioN of CCM® Therapy for Heart Failure

Acronym: CCM OPEN HF

Important dates

Study start
2025
Primary completion
2035
Study completion
2036
First posted
Aug 8, 2025
Registry last updated
Apr 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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