Propensity-Matched Study of Cardiac Contractility Modulation Therapy in Heart Failure
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorImpulse Dynamics
About this trial
The purpose of this prospective, multi-center, propensity-matched coverage with evidence development (CED) study is to assess the impact of cardiac contractility modulation (CCM) on mortality and heart failure hospitalizations in Medicare-eligible patients with heart failure who meet indications for CCM.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Continuous representation in the database in the year prior to index.
Age 18 or older will be enrolled in either the treatment or control arm of the study.
NYHA III heart failure,
Not receiving CRT
Disqualifiers
Subject has had a prior heart transplant
Subject with mechanical tricuspid valve.
Subject has a left ventricular assist device (LVAD).
Trial population
Participants are patients with heart failure who are identified from a large, de-identified, multi-system electronic health record (EHR) database representing diverse healthcare settings across the United States. The database includes patients receiving care in hospitals, outpatient clinics, and other sites where cardiac contractility modulation (CCM) therapy is delivered. The population reflects typical sites of CCM implantation in Medicare-eligible adults across multiple states and integrated delivery networks (IDNs).
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Cardiac Contractility Modulation (CCM)
DeviceCCM is a therapy delivered via the Optimizer System, which is implanted in eligible heart failure patients. The device delivers non-excitatory electrical signals to the heart during the absolute refractory period, enhancing the strength of cardiac contractions without increasing myocardial oxygen consumption.
Treatment groups
4,200 Participants
are divided into 2 treatment groupsGroup A: Treatment Group1 intervention
Group B: Control Group0 interventions
Trial outcomes
Primary outcomes
1
Time to first heart failure hospitalization or all-cause death
Time from index date to the first occurrence of either heart failure-related hospitalization or death in patients with a clinical indication for cardiac contractility modulation (CCM) therapy. Outcomes will be compared between patients implanted with the Optimizer System (treatment arm) and a propensity score-matched control group of patients who are eligible for CCM but did not receive the device. Data will be collected from a large, de-identified, multi-system electronic health record database representing diverse sites of care across the United States.
Time frame
Up to 2 years post-index date for each patient; follow-up will continue until 2 years after the last patient is enrolled to allow at least 2 years of observation for all participants.Other outcomes
1
Time to recurrent heart failure hospitalization
Time from index date (CCM implantation for treatment patients) to each heart failure-related hospitalization, including first and subsequent hospitalizations, in patients receiving CCM therapy compared with a matched control group of patients eligible for CCM but not treated. This outcome is exploratory and hypothesis-generating.
Time frame
Up to 2 years post-index date for each patient; follow-up continues until 2 years after the last patient is enrolled to allow at least 2 years of observation.2
Time to all-cause mortality
Time from index date (CCM implantation for treatment patients) to death from any cause, in patients receiving CCM therapy compared with a matched control group of patients eligible for CCM but not treated. This outcome is exploratory and hypothesis-generating.
Time frame
Up to 2 years post-index date for each patient; follow-up continues until 2 years after the last patient is enrolled to allow at least 2 years of observation.Sponsors and contacts
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Source ClinicalTrials.gov