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

Monaldi Hospital

Status: Unknown

Conditions: Heart Failure, Systolic

Treatments: Device: Device for Cardiac Contractility Modulation Therapy (CCM)

Study type: Observational

Funder types: Other

Identifiers

NCT04902079

CCM-001Mon

Details and patient eligibility

About

Observational and perspective study with acute and chronic endpoint.

Full description

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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18 to 90 years old

Volunteers: Accepts Healthy Volunteers

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