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

Overview

About this study

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.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

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; or 
  • *Recent cardiovascular or peripheral vascular surgery within 30 days of enrollment is defined as the following:
    • Percutaneous valvular correction ≤ 30 days;
    • Femoral or abdominal vascular procedure involving incisional access ≤ 30 days;
    • Peripheral arterial endovascular procedure or surgery ≤ 30 days;Cardiac surgery ≤ 72 hrs with ongoing complications, ongoing mediastinal drainage, or re-do sternotomy attributed to bleeding ≤ 30 days;
    • Tricuspid valve replacement or annuloplasty ≤ 30 days;
    • Any endovascular procedure with specified complication ≤ 30 days;
    • Femoral access site-vascular complication including hematoma requiring transfusion, surgical intervention or prolongation of hospitalization, arterio-venous fistula, pseudoaneurysm or tear;
    • New pericardial effusion more than trivial/mild, or requiring percutaneous/surgical drainage.
    • Acute deep venous thrombosis.

Eligibility last updated 8/19/21. Questions regarding updates should be directed to the study team contact.

 

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Paul Friedman, M.D.

Open for enrollment

Contact information:

Lynn Stamschror R.N.

(507) 255-9019

Polk.Lynn@mayo.edu

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available