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AXONE-Acute II: Acute Assessment of a Micro Multipolar Lead for Enhanced Cardiac Resynchronisation Therapy (AXONE-Acute-2)

U

University Hospital, Rouen

Status

Unknown

Conditions

Cardiac Resynchronisation Therapy

Treatments

Device: Implant test procedure

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT04156412
2019/127/HP

Details and patient eligibility

About

Pilot study to evaluate the performance of a lead below 2 French with specific distal shape to deliver efficient LV pacing

Enrollment

28 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Male or female patient aged ≥18 years old.
  • Patient presenting a CRT-P or CRT-D indication according to the latest ESC guidelines1.
  • Primary implant of a CRT device (including upgrade from a single or dual-chamber pacemaker or ICD).
  • Signed and dated informed consent.

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 according to Modification of diet in renal disease formula (MDRD) < 30ml/mn/m²).
  • Previous failure of 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.
  • Vulnerable patient such as person deprived of liberty by administrative or judicial decision or placed under judicial protection (guardianship or supervision).
  • Known pregnancy, breastfeeding or women in childbearing age without an adequate contraceptive method with a known failure rate < 1%.-

Trial design

Primary purpose

Other

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

28 participants in 1 patient group

Implant test procedure
Experimental group
Description:
Implant test procedure with new LV quadripolar lead before a standard implantation for Cardiac resynchronisation therapy
Treatment:
Device: Implant test procedure

Trial contacts and locations

7

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Central trial contact

Frédéric ANSELME, Pr; Julien BLOT

Data sourced from clinicaltrials.gov

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