Assessment of the Axone Micro Quadripolar Lead for Enhanced Cardiac Resynchronization Therapy (ASTRAL-4LV)

January 3, 2024 updated by: MicroPort CRM
The primary objective of this study is to assess the chronic safety and performance of the Axone left ventricular (LV) micro-lead.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

92

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Austria
      • Linz, Austria
        • Kepler Universitätsklinikum
  • France
      • Annecy, France
        • CH Annecy Genevois
      • Chambray-lès-Tours, France
        • CHRU Hopital Trousseau
      • Clermont-Ferrand, France
        • CHU de Clermont-Ferrand
      • Grenoble, France
        • CHU Grenoble
      • Lille, France
        • CHRU de Lille - Hopital Cardiologique
      • Rennes, France
        • CHU Pontchaillou
      • Rouen, France
        • CHU de Rouen
      • Toulouse, France
        • CHU Toulouse
  • Germany
      • Hamburg, Germany
        • Universitätsklinikum Hamburg Eppendorf
      • Heidelberg, Germany
        • Universitätsklinikum Heidelberg
      • Kiel, Germany
        • Universitätsklinikum Schleswig-Holstein Campus Kiel
  • Italy
      • Brescia, Italy
        • ASST Spedali Civili di Brescia
      • Naples, Italy
        • Ospedale Pellegrini
      • Naples, Italy
        • Ospedale Policlinico Federico II
  • Netherlands
      • Zwolle, Netherlands
        • Isala Klinieken
  • Portugal
      • Lisbon, Portugal
        • Centro Hospitalar Universitário Lisboa Norte - Hospital De Santa Maria
      • Porto, Portugal
        • Centro Hospitalar Universitario do Porto
  • Spain
      • Alicante, Spain
        • Hospital Universitario General de Alicante
      • Valencia, Spain
        • Hospital Universitario La Fe
      • Vigo, Spain
        • Hospital Álvaro Cunqueiro

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Axone 4LV Lead
Subjects implanted with the Axone 4LV Lead
Device: Implantation of the Axone 4LV Lead
Implantation of the Axone 4LV Lead

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety co-primary endpoint, defined as Axone system related complication free rate at 6 months post implant
Time Frame: 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).
6 months
Performance co-primary endpoint, defined as LV pacing success rate at 6 months post implant
Time Frame: 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.
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Bizone LV pacing success rate at 6 months post implant
Time Frame: 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.
6 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Axone 4LV implantation success rate
Time Frame: At implant, preferably within 15 days of enrollment
At implant, preferably within 15 days of enrollment
Implantation duration
Time Frame: At implant, preferably within 15 days of enrollment
At implant, preferably within 15 days of enrollment
Fluoroscopy time
Time Frame: At implant, preferably within 15 days of enrollment
Fluoroscopy time is measured in minutes
At implant, preferably within 15 days of enrollment
Fluoroscopy dose
Time Frame: At implant, preferably within 15 days of enrollment
Fluoroscopy dose is measured using dose area product (Gray.cm^2)
At implant, preferably within 15 days of enrollment
Axone system handling assessment
Time Frame: At implant, preferably within 15 days of enrollment
Implanters will be asked to fill in a handling questionnaire and record observations related to the use of the Axone system.
At implant, preferably within 15 days of enrollment
Axone implanters' learning curve
Time Frame: At implant, preferably within 15 days of enrollment
This endpoint will be based on fluoroscopy time for implantation. The effect of removing the 1st, 2nd, 3rd, etc implanted subjects on mean fluoroscopy time (per implanter and per site) will be calculated.
At implant, preferably within 15 days of enrollment
Number of excitable myocardium areas at implant
Time Frame: At implant, preferably within 15 days of enrollment
"Excitable myocardium areas" are areas that can be paced by the implanted Axone 4LV lead.
At implant, preferably within 15 days of enrollment
Effect of CRT therapy, in particular bizone pacing, on QRS parameters, at discharge and 6 months post implant
Time Frame: At discharge, within 7 days of implant, and at 6 months
The effect of monozone and bizone CRT pacing on duration of QRS is measured in milliseconds.
At discharge, within 7 days of implant, and at 6 months
Effect of CRT therapy, in particular bizone pacing, on Left Pre-Ejection Interval (LPEI), at discharge
Time Frame: At discharge, within 7 days of implant
LPEI (in milliseconds) is an electromechanical parameter that can be assessed using echocardiography.
At discharge, within 7 days of implant
Axone 4LV lead pacing threshold
Time Frame: Discharge (within 7 days of implant), 6 weeks, 3 months, 6 months, 12 months, 24 months 36 months, 48 months
Pacing threshold is measured in Volts.
Discharge (within 7 days of implant), 6 weeks, 3 months, 6 months, 12 months, 24 months 36 months, 48 months
Axone 4LV lead pacing impedance
Time Frame: Discharge (within 7 days of implant), 6 weeks, 3 months, 6 months, 12 months, 24 months 36 months, 48 months
Pacing impedance is measured in Ohms.
Discharge (within 7 days of implant), 6 weeks, 3 months, 6 months, 12 months, 24 months 36 months, 48 months
Presence of phrenic nerve stimulation (PNS) with the Axone 4LV lead
Time Frame: Implant (preferably within 15 days of enrollment), discharge (within 7 days of implant), 6 weeks, 3 months, 6 months
The presence of PNS will be assessed at 10V using an external pacing system analyzer at implant, or at pacing threshold +2V at other visits.
Implant (preferably within 15 days of enrollment), discharge (within 7 days of implant), 6 weeks, 3 months, 6 months
Axone 4LV lead programming
Time Frame: Discharge (within 7 days of implant), 6 weeks, 3 months, 6 months, 12 months, 24 months 36 months, 48 months
Lead programming will be reported using: (i) pacing amplitude (Volts), pulse width (milliseconds) and pacing vector(s) selected.
Discharge (within 7 days of implant), 6 weeks, 3 months, 6 months, 12 months, 24 months 36 months, 48 months
Energy consumption associated with Axone 4LV lead
Time Frame: 6 months
Energy will be calculated using the formula: E=(pacing amplitude^2 x pulse width)/impedance. Energy, pacing amplitude, pulse width and impedance are measured in Joules, Volts, milliseconds, and Ohms, respectively.
6 months
Axone system-related annual complication-free rate
Time Frame: 12 months, 24 months 36 months, 48 months
Definition of Axone system related complication is the same as for primary safety endpoint.
12 months, 24 months 36 months, 48 months
Clinical response to CRT at 12 months post implant
Time Frame: 12 months

Clinical response will be determined by looking at functional improvement, reverse remodelling, freedom from heart failure events, and rate of non-responders:

(i) functional improvement is defined as improvement in ≥1 NYHA (New York Heart Association) class from baseline to 12 months.

(ii) reverse remodelling is a ≥12% increase in left ventricular end systolic volume index (LVESVi: LVESV [mL] and body surface area [m^2] will be combined to report LVESVi).

(iii) freedom from heart failure events is defined as an absence of death or HF hospitalization.

(iv) non-responders are all those who are not responders. A responder is defined as a subject that is not dead and who did not experience any HF hospitalization and that has a stable or improved NYHA class versus baseline.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

MicroPort CRM

Investigators

  • Principal Investigator: Frédéric Anselme, MD, CHU de Rouen, France

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 3, 2020

Primary Completion (Estimated)

June 1, 2024

Study Completion (Estimated)

December 1, 2027

Study Registration Dates

First Submitted

June 23, 2020

First Submitted That Met QC Criteria

July 3, 2020

First Posted (Actual)

July 9, 2020

Study Record Updates

Last Update Posted (Actual)

January 5, 2024

Last Update Submitted That Met QC Criteria

January 3, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LAXI01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Heart Failure

Clinical Trials on Implantation of the Axone 4LV Lead

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Belgium

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe