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

Sponsor
Monaldi Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT04902079
Collaborator
(none)
20
1
33.8
0.6

Study Details

Study Description

Brief Summary

Observational and perspective study with acute and chronic endpoint.

Condition or Disease Intervention/Treatment Phase
  • Device: Device for Cardiac Contractility Modulation Therapy (CCM)

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 Design

Study Type:
Observational
Anticipated Enrollment :
20 participants
Observational Model:
Other
Time Perspective:
Prospective
Official Title:
Observational and Prospective Registry on Cardiac Contractility Modulation (CCM) Therapy
Actual Study Start Date :
Mar 8, 2021
Anticipated Primary Completion Date :
Jun 30, 2022
Anticipated Study Completion Date :
Dec 31, 2023

Outcome Measures

Primary Outcome Measures

  1. 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

  2. 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

  3. 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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 90 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Monaldi Hospital Naples Italy 80131

Sponsors and Collaborators

  • Monaldi Hospital

Investigators

  • Study Director: Antonio D'Onofrio, MD, Ao dei Colli - Monaldi Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Antonio D'Onofrio, Head of UOSD Elettrofisiologia Studio e Terapia delle Aritmie, Monaldi Hospital
ClinicalTrials.gov Identifier:
NCT04902079
Other Study ID Numbers:
  • CCM-001Mon
First Posted:
May 26, 2021
Last Update Posted:
Jun 3, 2021
Last Verified:
Jun 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
Yes
Product Manufactured in and Exported from the U.S.:
No
Keywords provided by Antonio D'Onofrio, Head of UOSD Elettrofisiologia Studio e Terapia delle Aritmie, Monaldi Hospital
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 3, 2021