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

Cardiac Resynchronisation Therapy Clinical Trial

— AXONE-Acute  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03750058
• Other study ID #: 2017/170/HP
• Status: Completed
• Phase: N/A
• Start date: August 8, 2018
• Est. completion date: December 13, 2018

Study information

• Verified date: February 2019
• Source: University Hospital, Rouen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: December 13, 2018
• Est. primary completion date: December 13, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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%).

Related Conditions & MeSH terms

• Cardiac Resynchronisation Therapy

Intervention

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

Locations

Country	Name	City	State
France	Bordeaux University Hospital	Bordeaux
France	Lille University Hospital	Lille
France	Rennes University Hospital	Rennes
France	Rouen University Hospital	Rouen

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Rouen	MicroPort CRM

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	LV Multizone pacing success rate	Percent of patients where the placement of the AXONE lead provides two distant LV pacing vectors matching Pacing Threshold = 3.5V/0.5ms	20 min
Primary	LV pacing success rate	Percent of patients where the placement of the AXONE lead allows at least one LV pacing vector matching Pacing Threshold = 3.5V/0.5ms	20 min
Secondary	Implant testing Procedure-related Adverse Events procedure.		1 month post testing
Secondary	Electrical performance of device (1)	Electrical performance focusing on LV pacing threshold (Volts)	20 min
Secondary	Electrical performance of device (2)	Electrical performance focusing on LV pacing impedance (Ohm)	20 min
Secondary	Lead Implant Efficiency	procedure time for successful placement	20 min
Secondary	Lead Implant Efficiency	Radiation dose during implant	20 min
Secondary	Satisfaction of implanter	handling assessment of implanter using satisfaction scale	20 min