Status:
UNKNOWN
CCM Italian Registry
Lead Sponsor:
S. Andrea Hospital
Collaborating Sponsors:
Ospedale Umberto I di Torino
A.O.U. Città della Salute e della Scienza - Molinette Hospital
Conditions:
Heart Failure
Eligibility:
All Genders
18-90 years
Brief Summary
The Cardiac Contractility Modulation (CCM) system is a cardiac implantable device indicated for the treatment of patients with symptomatic heart failure with left ventricular systolic dysfunction desp...
Detailed Description
Introduction The Cardiac Contractility Modulation (CCM) system is a cardiac implantable device indicated for the treatment of patients with symptomatic heart failure with left ventricular systolic dys...
Eligibility Criteria
Inclusion
- chronic heart failure with reduced left ventricular systolic function (EF ≤ 45%), symptomatic (class NYHA III or greater; or class II with previous episodes of acute decompensation for patients with FE 36-45%);
- presence of appropriate and optimized medical therapy, including: beta-blocker and angiotensin-converting enzyme inhibitor or angiotensin-receptor blocker or angiotensin-receptor neprylysin inhibitor and anti-aldosterone agent, titrated as tolerated by the patients;
- narrow QRS (\<120 msec) or cardiac resynchronization carriers with documented non-response to this treatment;
- age above 18 years;
- written informed consent for enrollment and participation in the prospective register.
Exclusion
- life expectancy \< 1 year due to non-cardiac comorbidities that reduce the prognosis;
- absence of vascular access that can be used for the implant;
- other contraindications to the CCM implantation procedure (e.g. active infective processes, active severe coagulopathies);
- refusal to be enrolled in the registry.
Key Trial Info
Start Date :
September 1 2019
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
September 1 2023
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT04327323
Start Date
September 1 2019
End Date
September 1 2023
Last Update
March 31 2020
Active Locations (1)
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1
Sant'Andrea Hospital
Vercelli, VC, Italy, 13100