Observational and Prospective Registry on Cardiac Contractility Modulation (CCM) Therapy

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-03-08

Study Completion Date

2023-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Observational and perspective study with acute and chronic endpoint.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

CCM and Implementation of Guideline-Directed Medical Therapy in Patients With Heart Failure (Fix-GDMT-HF)

NCT06580392

Heart Failure

RECRUITING

Cardiac Contractility Modulation (CCM) Therapy in Subjects With Medically Refractory Heart Failure

NCT02857309

Heart Failure

TERMINATED NA

Effects of CCM-therapy in Patients With Heart Failure

NCT02895048

Heart Failure

COMPLETED

CCM in Heart Failure With Preserved Ejection Fraction

NCT03240237

Heart Failure, Diastolic

COMPLETED NA

Propensity-Matched Study of Cardiac Contractility Modulation Therapy in Heart Failure

NCT07209098

Heart Failure and Reduced Ejection Fraction NYHA Class III Heart Failure

RECRUITING

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

This registry includes patients who have undergone implantation of the cardiac contractility modulation device due to the presence of heart failure with reduced left ventricular systolic function and symptomatic despite optimal therapy, as indicated in the guidelines of the ESC of 2016 and the Expert Consensus Document of the ESC Heart Failure group published in May 2019 for to assess the benefits after the CCM device.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Heart Failure, Systolic

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Device for Cardiac Contractility Modulation Therapy (CCM)

Evaluate the effect from CCM Therapy in HF population

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Male or non-pregnant female, aged 18 or older;
* chronic heart failure with symptomatic left ventricular systolic function; (NYHA class II-IVa) with or without device already implanted (for example AICD, pace-maker);
* Appropriate and optimized medical therapy
* Patient signed and dated informed consent form at enrollment;
* life expectancy\> 1 year due to the absence of comorbidities that reduce the prognosis

Exclusion Criteria

* absence of venous access available for implant;
* contraindication to the interventional procedure of CCM device implant (for example presence of Mechanical tricuspid vale);
* pregnant patients

Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes