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

• Conditions: Heart Failure, Systolic

• Registration Number: NCT04902079
• Lead Sponsor: Monaldi Hospital

Brief Summary

Observational and perspective study with acute and chronic endpoint.

Detailed 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.

Study Timeline

• Study Start: 2021-03-08
• Study First Submitted: 2021-05-15
• Study First Submitted QC: 2021-05-20
• Study First Posted: 2021-05-26
• Status Verified: 2021-06
• Last Update Submitted: 2021-06-02
• Last Update Posted: 2021-06-03
• Primary Completion: 2022-06-30
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Improvement Quality of Life	12 months	Evaluatation of the impact on CCM Therapy on Quality of Life evaluated from the reduction of MLWHFQ score at FU post implant of CCM device compared to baseline
Functional Capacity	12 months	Evaluation of the impact on CCM Therapy on Functional Capacity evaluated from the gain of distance traveled in the 6MWT at FU post implant of CCM device compared to baseline
Reduction of HF Hospitalizations and Emergency Ward accesses	12 months	Reduction of HF Hospitalizations and Emergency Ward accesses at FU post implant of CCM device compared to number of HF hospitalization an Emergency Ward accesses collected 1 year before the implant of CCM therapy

Trial Locations

Locations (1)

Monaldi Hospital; 🇮🇹 Naples, Italy