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

Not Applicable

Active, not recruiting

• Conditions: Heart Failure; Cardiac Resynchronization Therapy
• Interventions: Device: Implantation of the Axone 4LV Lead

• Registration Number: NCT04463641
• Lead Sponsor: MicroPort CRM

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.

Study Timeline

• Study First Submitted: 2020-06-23
• Study First Submitted QC: 2020-07-03
• Study First Posted: 2020-07-09
• Study Start: 2020-12-03
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-03
• Last Update Posted: 2024-01-05
• Primary Completion: 2024-06
• Study Completion: 2027-12

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 92

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Axone 4LV Lead	Implantation of the Axone 4LV Lead	Subjects implanted with the Axone 4LV Lead

Primary Outcome Measures

Name	Time	Method
Performance co-primary endpoint, defined as LV pacing success rate at 6 months post implant	6 months	LV pacing success is defined as at least one LV pacing vector with: * Pacing Threshold (PT) ≤ 3.5V at 1ms pulse width, and; * No phrenic nerve stimulation at PT+2V / 1ms pulse width.
Safety co-primary endpoint, defined as Axone system related complication free rate at 6 months post implant	6 months	A complication is defined as any Serious Adverse Device Effect (SADE) resulting in death or requiring invasive intervention. Safety co-primary endpoint assessment will be based on independent event adjudication by a Clinical Event Committee (CEC).

Secondary Outcome Measures

Name	Time	Method
Bizone LV pacing success rate at 6 months post implant	6 months	Bizone LV pacing success is defined as two distant pacing vectors with: * A Pacing Threshold (PT) ≤ 3.5V at 1ms pulse width, and; * No phrenic nerve stimulation at PT +2V / 1ms pulse width. Two pacing vectors are considered distant when cathode electrodes are separated by at least 30 mm.

Trial Locations

Locations (21)

CHU Grenoble; 🇫🇷 Grenoble, France

ASST Spedali Civili di Brescia; 🇮🇹 Brescia, Italy

CHU de Clermont-Ferrand; 🇫🇷 Clermont-Ferrand, France

Ospedale Pellegrini; 🇮🇹 Naples, Italy

Hospital Álvaro Cunqueiro; 🇪🇸 Vigo, Spain

CHRU Hopital Trousseau; 🇫🇷 Chambray-lès-Tours, France

Hospital Universitario General de Alicante; 🇪🇸 Alicante, Spain

Universitätsklinikum Hamburg Eppendorf; 🇩🇪 Hamburg, Germany

Universitätsklinikum Heidelberg; 🇩🇪 Heidelberg, Germany

CH Annecy Genevois; 🇫🇷 Annecy, France

Kepler Universitätsklinikum; 🇦🇹 Linz, Austria

CHU Pontchaillou; 🇫🇷 Rennes, France

CHU de Rouen; 🇫🇷 Rouen, France

Universitätsklinikum Schleswig-Holstein Campus Kiel; 🇩🇪 Kiel, Germany

Hospital Universitario La Fe; 🇪🇸 Valencia, Spain

Isala Klinieken; 🇳🇱 Zwolle, Netherlands

Centro Hospitalar Universitário do Porto; 🇵🇹 Porto, Portugal

Ospedale Policlinico Federico II; 🇮🇹 Naples, Italy

Centro Hospitalar Universitário Lisboa Norte - Hospital de Santa Maria; 🇵🇹 Lisbon, Portugal

CHRU de Lille - Hôpital Cardiologique; 🇫🇷 Lille, France

CHU Toulouse; 🇫🇷 Toulouse, France