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

  • STATUS
    Recruiting
  • End date
    Dec 18, 2025
  • participants needed
    152
  • sponsor
    MicroPort CRM
Updated on 18 December 2021
cardiac resynchronization therapy

Summary

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

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.

Details
Condition Heart Failure, Cardiac Resynchronization Therapy
Treatment Implantation of the Axone 4LV Lead
Clinical Study IdentifierNCT04463641
SponsorMicroPort CRM
Last Modified on18 December 2021

Eligibility

Yes No Not Sure

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)
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

0/250

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note