Acute Assessment of a Micro Multipolar Lead for Enhanced Cardiac Resynchronisation Therapy (NCT03750058) | Clinical Trial Compass
CompletedNot Applicable
Acute Assessment of a Micro Multipolar Lead for Enhanced Cardiac Resynchronisation Therapy
France20 participantsStarted 2018-08-08
Plain-language summary
Pilot study to evaluate the performance of a lead below 2 French with specific distal shape to deliver efficient LV pacing
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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 Criteria:
* 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%).