Assessment of the Axone Micro Quadripolar Lead for Enhanced Cardiac Resynchronization Therapy

NCT ID: NCT04463641

Last Updated: 2024-01-05

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 92 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-12-03
• Study Completion Date: 2027-12-31

Brief Summary

The primary objective of this study is to assess the chronic safety and performance of the Axone left ventricular (LV) micro-lead.

Detailed Description

This is a interventional, pivotal, prospective, single arm, open label, multicenter, international trial.

The device under investigation is the Axone system, consisting of:

• Axone 4LV: an ultrathin, lumenless, quadripolar, IS4-compatible lead designed for left ventricular pacing for cardiac resynchronization therapy (CRT).
• Axone µGuide: a dedicated, permanently implantable micro catheter designed for implantation of the Axone 4LV lead.

The primary endpoint data will be used to support CE marking of the Axone system.

The primary endpoints will be evaluated at 6 months post-implantation. Subjects will be followed-up at 6 weeks, 3 months, 6 months, 12 months post-implantation, then yearly until 4 years post-implantation.

Conditions

Heart Failure; Cardiac Resynchronization Therapy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Axone 4LV Lead

Subjects implanted with the Axone 4LV Lead

Group Type: EXPERIMENTAL

Implantation of the Axone 4LV Lead

Intervention Type: DEVICE

Implantation of the Axone 4LV Lead

Interventions

Implantation of the Axone 4LV Lead

Implantation of the Axone 4LV Lead

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Indication for cardiac resynchronization therapy-defibrillator (CRT-D) device implant according to the latest ESC (European Society of Cardiology) guidelines
• De-novo implant of a Platinium 4LV CRT-D device (or any newer 4LV CRT-D model manufactured by MicroPort CRM)
• Reviewed, signed and dated informed consent form

Exclusion Criteria

• LV lead previous implant attempt
• Upgrade to CRT from a previously implanted pacemaker or implantable cardioverter-defibrillator (ICD), or CRT device replacement
• Known allergy to contrast media used for imaging during cardiac catheterization
• Tricuspid valvular disease or any type of tricuspid replacement heart valve (mechanical or tissue)
• Severe renal failure (creatinine clearance according to the Modification of Diet in Renal Disease (MDRD) formula < 30ml/min/m²)
• Active myocarditis
• Stroke, myocardial infarction or cardiac revascularization within 40 days prior to implant
• Previous heart transplant or currently on heart transplant list
• Life expectancy less than 1 year
• Already included in another clinical study that could confound the results of this study
• Pre-menopausal women / women in childbearing age, including pregnant and breastfeeding women
• Less than 18 years old or under guardianship
• Incapacitated subject, inability to understand the purpose of the study, or to meet follow-up visits at the implanting site as defined in the protocol
• Diagnosis of drug addiction (substance use disorder)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

MicroPort CRM

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Frédéric Anselme, MD

Role: PRINCIPAL_INVESTIGATOR

CHU de Rouen, France

Locations

Kepler Universitätsklinikum

Linz, , Austria

CH Annecy Genevois

Annecy, , France

CHRU Hopital Trousseau

Chambray-lès-Tours, , France

CHU de Clermont-Ferrand

Clermont-Ferrand, , France

CHU Grenoble

Grenoble, , France

CHRU de Lille - Hôpital Cardiologique

Lille, , France

CHU Pontchaillou

Rennes, , France

CHU de Rouen

Rouen, , France

CHU Toulouse

Toulouse, , France

Universitätsklinikum Hamburg Eppendorf

Hamburg, , Germany

Universitätsklinikum Heidelberg

Heidelberg, , Germany

Universitätsklinikum Schleswig-Holstein Campus Kiel

Kiel, , Germany

ASST Spedali Civili di Brescia

Brescia, , Italy

Ospedale Pellegrini

Naples, , Italy

Ospedale Policlinico Federico II

Naples, , Italy

Isala Klinieken

Zwolle, , Netherlands

Centro Hospitalar Universitário Lisboa Norte - Hospital de Santa Maria

Lisbon, , Portugal

Centro Hospitalar Universitário do Porto

Porto, , Portugal

Hospital Universitario General de Alicante

Alicante, , Spain

Hospital Universitario La Fe

Valencia, , Spain

Hospital Álvaro Cunqueiro

Vigo, , Spain

Countries

Austria; France; Germany; Italy; Netherlands; Portugal; Spain

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Other Identifiers

LAXI01

Identifier Type: -

Identifier Source: org_study_id