The LEADLESS II IDE Study (Phase II): A Safety and Effectiveness Trial for a Leadless Pacemaker System

  • STATUS
    Recruiting
  • End date
    Mar 27, 2022
  • participants needed
    615
  • sponsor
    Abbott Medical Devices
Updated on 27 June 2021
Investigator
Sharon Rabine
Primary Contact
Na Homolce Hospital (1.2 mi away) Contact
+52 other location

Summary

prospective, non-randomized, multi-center, international clinical study is designed to confirm the safety and effectiveness of the Aveir LP System in a subject population indicated for a VVI(R) pacemaker.

Details
Treatment Aveir Leadless Pacemaker System
Clinical Study IdentifierNCT04559945
SponsorAbbott Medical Devices
Last Modified on27 June 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Subject must have one of the clinical indications before device implant in adherence with Medicare, ACC/AHA/HRS/ESC single chamber pacing guidelines including
Chronic and/or permanent atrial fibrillation with 2 or 3 AV or bifascicular bundle branch block (BBB block), including slow ventricular rates (with or without medication) associated with atrial fibrillation; or
Normal sinus rhythm with 2 or 3 AV or BBB block and a low level of physical activity or short expected lifespan (but at least one year); or
Sinus bradycardia with infrequent pauses or unexplained syncope with EP findings; and
Subject is 18 years of age; and
Subject has a life expectancy of at least one year; and
Subject is not enrolled in another clinical investigation; and
Subject is willing to comply with clinical investigation procedures and agrees to return for all required follow-up visits, tests, and exams; and
Subject has been informed of the nature of the study, agrees to its provisions and has provided a signed written informed consent, approved by the IRB/EC; and
Subject is not pregnant and does not plan to get pregnant during the course of the study

Exclusion Criteria

Subject has known pacemaker syndrome, has retrograde VA conduction, or suffers a drop in arterial blood pressure with the onset of ventricular pacing; or
Subject is allergic or hypersensitive to < 1 mg of dexamethasone sodium phosphate (DSP)
Subject has a mechanical tricuspid valve prosthesis; or
Subject has a pre-existing endocardial pacing or defibrillation leads; or
Subject has current implantation of either conventional or subcutaneous implantable cardioverter defibrillator (ICD) or cardiac resynchronization therapy (CRT) device; or
Subject has an implanted vena cava filter; or
Subject has evidence of thrombosis in one of the veins used for access during the procedure; or
Subject had recent cardiovascular or peripheral vascular surgery within 30 days of enrollment; or
Subject has an implanted leadless cardiac pacemaker
Clear my responses

How to participate?

Step 1 Connect with a site
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
Name

Primary Contact

site
Name

0/250
Preferred Language
Other Language
Please verify that you are not a bot.

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...

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