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

Heart Failure, Systolic Clinical Trial

— REPORT-CCM  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04902079
• Other study ID #: CCM-001Mon
• Status: Recruiting
• Start date: March 8, 2021
• Est. completion date: December 31, 2023

Study information

• Verified date: June 2021
• Source: Monaldi Hospital
• Contact: Antonio D'Onofrio, MD
• Phone: 337768956
• Email: donofrionat1[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Observational and perspective study with acute and chronic endpoint.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: December 31, 2023
• Est. primary completion date: June 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Heart Failure
• Heart Failure, Systolic

Intervention

Device:
• Device for Cardiac Contractility Modulation Therapy (CCM)
Evaluate the effect from CCM Therapy in HF population

Locations

Country	Name	City	State
Italy	Monaldi Hospital	Naples

Sponsors (1)

Lead Sponsor	Collaborator
Monaldi Hospital

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improvement Quality of Life	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	12 months
Primary	Functional Capacity	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	12 months
Primary	Reduction of HF Hospitalizations and Emergency Ward accesses	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	12 months