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

Cardiac Resynchronisation Therapy Clinical Trial

— AXONE-Acute-2  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04156412
• Other study ID #: 2019/127/HP
• Status: Recruiting
• Phase: N/A
• Start date: January 2, 2020
• Est. completion date: October 2020

Study information

• Verified date: June 2020
• Source: University Hospital, Rouen
• Contact: Frédéric ANSELME, Pr
• Phone: +3323288
• Email: frederic.anselme[@]chu-rouen.fr
• 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: Recruiting
• Enrollment: 28
• Est. completion date: October 2020
• Est. primary completion date: October 2020
• 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 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%.-

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	Clermont-Ferrand University Hospital	Clermont-Ferrand
France	Lille University Hospital	Lille
France	Rennes University Hospital	Rennes
France	Rouen University Hospital	Rouen
Spain	Hospital Universitari Germans Trias i Pujol	Badalona
Spain	Hospital Universitario y Politécnico La Fe	Valencia

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Rouen	MicroPort CRM

Countries where clinical trial is conducted

France,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	LV Bi-zone 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.	30 min
Primary	LV pacing success rate	Percent of patients where the placement of the AXONE lead allows at least one LV pacing vectors matching: Pacing Threshold = 3.5V/0.5ms.	30 min
Secondary	Device or Implant testing procedure-related Adverse Events		1 month post intervention
Secondary	Electrical performance (1)	LV pacing threshold (Volt)	30 min
Secondary	Electrical performance (2)	LV pacing impedance (Ohm)	30 min
Secondary	AXONE Implant Efficiency (1)	procedure time for successful placement	30 min
Secondary	AXONE Implant Efficiency (2)	fluoroscopic time	30 min
Secondary	AXONE Implant Efficiency (3)	radiation dose	30 min
Secondary	AXONE Implant Efficiency (4)	handling assessment.	30 min
Secondary	LV multipoint pacing success	the placement of the AXONE provides two pacing vectors matching	30 min