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

NCT04902079 | Unknown FDA Device

• 1 other identifier: CCM-001Mon
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Observational and perspective study with acute and chronic endpoint.

Conditions

Heart Failure, Systolic

Keywords

Heart Failure; Quality of Life; Cardiac Contractility Modulation

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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

Interventions

Device for Cardiac Contractility Modulation Therapy (CCM) DEVICE

Evaluate the effect from CCM Therapy in HF population

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with standard indication to CardiaC Contractility Modulation (CCM) therapy device system implantation

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Monaldi Hospital: lead

Study Sites (1)

Monaldi Hospital

Naples, 80131, Italy

RECRUITING

MeSH Terms

Conditions

Heart Failure, Systolic; Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Antonio D'Onofrio, MD

  Ao dei Colli - Monaldi Hospital

  STUDY DIRECTOR

Central Study Contacts

Antonio D'Onofrio, MD

CONTACT

337768956; donofrionat1@gmail.com

Giuliano D'Alterio, MD

CONTACT

3332785271; gdalterio@libero.it

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of UOSD Elettrofisiologia Studio e Terapia delle Aritmie

Study Record Dates

• First Submitted: May 15, 2021
• First Posted: May 26, 2021
• Study Start: March 8, 2021
• Primary Completion: June 30, 2022
• Study Completion: December 31, 2023
• Last Updated: June 3, 2021

Record last verified: 2021-06

Locations

IT (1)