Acute Assessment of a Micro Multipolar Lead for Enhanced Cardiac Resynchronisation Therapy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-08-08

Study Completion Date

2018-12-13

Brief Summary

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

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Detailed Description

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Conditions

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Cardiac Resynchronisation Therapy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DEVICE_FEASIBILITY

Blinding Strategy

NONE

Study Groups

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Implant test procedure

Implant test procedure with new LV quadripolar lead before a standard implantation for Cardiac resynchronisation therapy

Group Type EXPERIMENTAL

Implant test procedure

Intervention Type DEVICE

Implant test procedure with new LV quadripolar lead before a standard implantation for Cardiac resynchronisation therapy

Interventions

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Implant test procedure

Implant test procedure with new LV quadripolar lead before a standard implantation for Cardiac resynchronisation therapy

Intervention Type DEVICE

Eligibility Criteria

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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%).

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No