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

• Sponsor: University Hospital, Rouen (Other)
• Overall Status: Completed
• CT.gov ID: NCT03750058
• Collaborator: MicroPort CRM (Industry)
• Enrollment: 20
• Locations: 4
• Arm: 1
• Actual Duration (Months): 4.2
• Patients Per Site: 5
• Patients Per Site Per Month: 1.2

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Cardiac Resynchronisation Therapy	Device: Implant test procedure	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 20 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Device Feasibility
• Official Title: AXONE -Acute : Acute Assessment of a Micro Multipolar Lead for Enhanced Cardiac Resynchronisation Therapy
• Actual Study Start Date: Aug 8, 2018
• Actual Primary Completion Date: Dec 13, 2018
• Actual Study Completion Date: Dec 13, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Implant test procedure Implant test procedure with new LV quadripolar lead before a standard implantation for Cardiac resynchronisation therapy	Device: Implant test procedure; Implant test procedure with new LV quadripolar lead before a standard implantation for Cardiac resynchronisation therapy

Outcome Measures

Primary Outcome Measures

1. LV Multizone pacing success rate [20 min]

   Percent of patients where the placement of the AXONE lead provides two distant LV pacing vectors matching Pacing Threshold ≤ 3.5V/0.5ms

2. LV pacing success rate [20 min]

   Percent of patients where the placement of the AXONE lead allows at least one LV pacing vector matching Pacing Threshold ≤ 3.5V/0.5ms

Secondary Outcome Measures

1. Implant testing Procedure-related Adverse Events procedure. [1 month post testing]

2. Electrical performance of device (1) [20 min]

   Electrical performance focusing on LV pacing threshold (Volts)

3. Electrical performance of device (2) [20 min]

   Electrical performance focusing on LV pacing impedance (Ohm)

4. Lead Implant Efficiency [20 min]

   procedure time for successful placement

5. Lead Implant Efficiency [20 min]

   Radiation dose during implant

6. Satisfaction of implanter [20 min]

   handling assessment of implanter using satisfaction scale

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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%).

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Bordeaux University Hospital	Bordeaux		France
2	Lille University Hospital	Lille		France
3	Rennes University Hospital	Rennes		France
4	Rouen University Hospital	Rouen		France

Sponsors and Collaborators

• University Hospital, Rouen
• MicroPort CRM

Investigators

• Principal Investigator: Frédéric ANSELME, Pr, Rouen University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University Hospital, Rouen
• ClinicalTrials.gov Identifier: NCT03750058
• Other Study ID Numbers: 2017/170/HP
• First Posted: Nov 21, 2018
• Last Update Posted: Feb 19, 2019
• Last Verified: Feb 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by University Hospital, Rouen: quadripolar LV leads

Study Results

No Results Posted as of Feb 19, 2019