Status:
COMPLETED
Acute Assessment of a Micro Multipolar Lead for Enhanced Cardiac Resynchronisation Therapy
Lead Sponsor:
University Hospital, Rouen
Collaborating Sponsors:
MicroPort CRM
Conditions:
Cardiac Resynchronisation Therapy
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Pilot study to evaluate the performance of a lead below 2 French with specific distal shape to deliver efficient LV pacing
Eligibility Criteria
Inclusion
- Male or female patient aged ≥18 years old.
- Patient presenting a CRT-P or CRT-D indication according to the latest ESC guidelines .
- Primary implant of a CRT device (including upgrade from a single or dual-chamber pacemaker or ICD).
- Signed and dated informed consent.
- Patient affiliated with, or beneficiary of a social security category.
Exclusion
- Class IV of NYHA (ambulatory or not).
- Allergy to contrast media used for imaging during cardiac catheterization.
- Severe Renal Failure (clearance of creatinine \< 30ml/mn/m²).
- Previous failure catheterization of the coronary sinus, or previous failure of left ventricular lead implantation.
- Already included in another clinical study involving intra-cardiac active implantable device, or participation to any other clinical trial in the last 2 weeks.
- Person deprived of liberty by administrative or judicial decision or placed under judicial protection (guardianship or supervision).
- Known pregnancy, breastfeeding women or in childbearing age without an adequate contraceptive method (failure rate \< 1%).
Key Trial Info
Start Date :
August 8 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 13 2018
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT03750058
Start Date
August 8 2018
End Date
December 13 2018
Last Update
February 19 2019
Active Locations (4)
Enter a location and click search to find clinical trials sorted by distance.
1
Bordeaux University Hospital
Bordeaux, France
2
Lille University Hospital
Lille, France
3
Rennes University Hospital
Rennes, France
4
Rouen University Hospital
Rouen, France