Status:
UNKNOWN
Observational and Prospective Registry on Cardiac Contractility Modulation (CCM) Therapy
Lead Sponsor:
Monaldi Hospital
Conditions:
Heart Failure, Systolic
Eligibility:
All Genders
18-90 years
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 8 2021
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2023
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT04902079
Start Date
March 8 2021
End Date
December 31 2023
Last Update
June 3 2021
Active Locations (1)
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1
Monaldi Hospital
Naples, Italy, 80131