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

N/AUnknownNCT04902079

Monaldi Hospital20 enrolled

Overview

Observational and perspective study with acute and chronic endpoint.

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 Type

OBSERVATIONAL

Enrollment

Conditions

Heart Failure, Systolic

Interventions

Device for Cardiac Contractility Modulation Therapy (CCM)DEVICE

Evaluate the effect from CCM Therapy in HF population

Eligibility

Sex: ALLMin age: 18 YearsMax age: 90 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Monaldi Hospital

Naples, Italy

RECRUITING

Outcomes

Primary Outcomes

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

Time frame: 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

Time frame: 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

Time frame: 12 months

Central Contacts

Antonio D'Onofrio, MD

CONTACT

337768956 donofrionat1@gmail.com

Giuliano D'Alterio, MD

CONTACT

3332785271 gdalterio@libero.it

Data from ClinicalTrials.gov

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