Status:
TERMINATED
Electrical Optimization of Cardiac Resynchronization Therapy in Non-responder Patients
Lead Sponsor:
CMC Ambroise Paré
Conditions:
Heart Failure
Cardiac Resynchronization Therapy
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Cardiac Resynchronization Therapy (CRT) is an established treatment for patients with systolic heart failure and bundle branch block, improving functional capacity, quality of life and reducing morbi-...
Detailed Description
This study is non-randomized, prospective, interventional, multicentric study. Patients who have been implanted with a CRT device between 6 and 18 months prior to inclusion and are considered non-resp...
Eligibility Criteria
Inclusion
- Patient older than 18
- Patient implanted with a CRT (CRT-P or CRT-D) more than 6 months but less than 18 months before inclusion
- Non-responder patients:
- Clinical criteria (Packer classification):
- Lack of improvement of NYHA functional class And/or hospitalization for heart failure
- Echocardiographic criteria:
- Lack of improvement of LVEF \> 5points And/or reduction of LVESV \< 15%
- Patient who had signed an informed consent and is willing to comply with study requirements
- Patient covered by French national healthcare insurance
Exclusion
- Permanent/persistant atrial fibrillation/ supra-ventricular tachycardia
- Scheduled hospitalization for major cardiac intervention or cardiac surgery in the 6 coming months
- Life-expectancy of less than 6 months
- Pregnant or breastfeeding women
- Adults under legal protection
Key Trial Info
Start Date :
February 22 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 14 2020
Estimated Enrollment :
27 Patients enrolled
Trial Details
Trial ID
NCT03789487
Start Date
February 22 2019
End Date
September 14 2020
Last Update
January 27 2021
Active Locations (3)
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1
GHEM Eaubonne
Montmorency, France, 95160
2
CHU de Poitiers
Poitiers, France, 86021
3
CMC Ambroise Paré
Neuilly-sur-Seine, Île-de-France Region, France, 92200