The LEADLESS II IDE Study for the Aveir VR Leadless Pacemaker System

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

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.

Study Overview

• Status: Completed
• Conditions: Bradycardia; Cardiac Rhythm Disorder
• Intervention / Treatment: Device: Aveir VR Leadless Pacemaker System

• Study Type: Interventional
• Enrollment (Actual): 1276
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Alberta
    • Calgary, Alberta, Canada
      • Foothills Medical Centre
  • Newfoundland and Labrador
    • St. John's, Newfoundland and Labrador, Canada, A1B 3V6
      • HSC, Eastern Health
  • Ontario
    • Kingston, Ontario, Canada
      • Kinsgston General Hospital
    • Newmarket, Ontario, Canada
      • Southlake Regional Health Centre
  • Quebec
    • Montreal, Quebec, Canada
      • Institut de Cardiologie de Montreal (Montreal Heart Inst.)
    • Québec, Quebec, Canada
      • Institut de Cardiologie de Quebec (Hospital Laval)
• Czechia
  • Prague, Czechia, 150 30
    • Na Homolce Hospital
• France
  • Grenoble, France
    • CHRU Albert Michallon
  • Marseille, France
    • Hopital d'adulte de la Timone
  • Rennes, France
    • CHRU Hopital de Pontchaillou
• Italy
  • Milan, Italy
    • Centro Cardiologico Monzino
• Netherlands
  • Amsterdam, Netherlands
    • Amsterdam Academic Medical Centre (AMC)
  • Zwolle, Netherlands
    • Isala - ZWolle
• Spain
  • Badajoz, Spain, 6080
    • Hospital Universitario Infanta Cristina
• United Kingdom
  • London, United Kingdom
    • Royal Brompton Hospital
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35294
      • University Hospital - University of Alabama at Birmingham (UAB)
    • Huntsville, Alabama, United States, 35801
      • The Heart Center PC
  • Arizona
    • Scottsdale, Arizona, United States, 85258
      • Honor Health
  • California
    • Long Beach, California, United States, 90803
      • University of Southern California
    • Newport Beach, California, United States, 92663
      • Premier Cardiology Inc
    • Pasadena, California, United States, 91105
      • Huntington Memorial Hospital
  • Colorado
    • Littleton, Colorado, United States, 80120
      • South Denver Cardiology Associates PC
  • Florida
    • Naples, Florida, United States, 34119
      • Naples Heart Rhythm Specialists PA
    • Orlando, Florida, United States, 32806
      • Orlando Health
  • Georgia
    • Athens, Georgia, United States, 30306
      • Piedmont Athens Regional Medical Center
    • Rome, Georgia, United States, 30165
      • Redmond Regional Medical Center
  • Kansas
    • Kansas City, Kansas, United States, 66160
      • Kansas University Medical Center
    • Overland Park, Kansas, United States, 66211
      • Kansas City Cardiac Arrhythmia Research Foundation
  • Kentucky
    • Edgewood, Kentucky, United States, 41017
      • St. Elizabeth Medical Center - South Unit
    • Lexington, Kentucky, United States, 40536
      • University of Kentucky
    • Lexington, Kentucky, United States, 40503
      • Baptist Health Lexington
  • Louisiana
    • New Orleans, Louisiana, United States, 70121
      • Ochsner Medical Center
  • Massachusetts
    • Burlington, Massachusetts, United States, 01805
      • Lahey Clinic Medical Center
  • Michigan
    • Detroit, Michigan, United States, 48236
      • Ascension St. John Hospital
    • Lansing, Michigan, United States, 48912
      • Sparrow Clinical Research Institute
    • Traverse City, Michigan, United States, 49684
      • Munson Medical Center
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic
  • Missouri
    • St Louis, Missouri, United States, 63141
      • Mercy Hospital St. Louis
  • New Jersey
    • Ocean Township, New Jersey, United States, 07712
      • Jersey Shore University Medical Center
  • New York
    • New York, New York, United States, 10029
      • Mount Sinai Hospital
    • New York, New York, United States, 10021
      • New York Presbyterian Hospital/Cornell University
    • Roslyn, New York, United States, 11576
      • Cardiac Arrhythmia & Pacemaker Center
  • North Carolina
    • Greensboro, North Carolina, United States, 27401
      • Cone Health Medical Group HeartCare
  • Ohio
    • Cleveland, Ohio, United States, 44106
      • University Hospitals Cleveland Medical Center
    • Cleveland, Ohio, United States, 44195
      • The Cleveland Clinic Foundation
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73112
      • Integris Baptist Medical Center
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15213
      • University of Pittsburgh Medical Center
    • York, Pennsylvania, United States, 17405
      • WellSpan Health
  • Tennessee
    • Memphis, Tennessee, United States, 38104
      • Methodist University Hospital
  • Texas
    • San Antonio, Texas, United States, 78201
      • South Texas Cardiovascular Consultants
    • The Woodlands, Texas, United States, 77380
      • Memorial Hermann Hospital
  • Utah
    • Salt Lake City, Utah, United States, 84132
      • University of Utah Hospital
  • Virginia
    • Falls Church, Virginia, United States, 22042
      • Inova Fairfax Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. 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
2. Subject is ≥18 years of age; and
3. Subject has a life expectancy of at least one year; and
4. Subject is not enrolled in another clinical investigation; and
5. Subject is willing to comply with clinical investigation procedures and agrees to return for all required follow-up visits, tests, and exams; and
6. 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
7. Subject is not pregnant and does not plan to get pregnant during the course of the study.

Exclusion Criteria:

1. Subject has known pacemaker syndrome, has retrograde VA conduction, or suffers a drop in arterial blood pressure with the onset of ventricular pacing; or
2. Subject is allergic or hypersensitive to < 1 mg of dexamethasone sodium phosphate (DSP);
3. Subject has a mechanical tricuspid valve prosthesis; or
4. Subject has a pre-existing endocardial pacing or defibrillation leads; or
5. Subject has current implantation of either conventional or subcutaneous implantable cardioverter defibrillator (ICD) or cardiac resynchronization therapy (CRT) device; or
6. Subject has an implanted vena cava filter; or
7. Subject has evidence of thrombosis in one of the veins used for access during the procedure; or
8. Subject had recent cardiovascular or peripheral vascular surgery within 30 days of enrollment; or
9. Subject has an implanted leadless cardiac pacemaker or
10. Subject is implanted with an electrically-active implantable medical device with stimulation capabilities (such as neurological or cardiac stimulators).

Study Plan

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Aveir VR Leadless Pacemaker; VVIR pacing	Device: Aveir VR Leadless Pacemaker System; Patients will undergo an attempted leadless pacemaker implant

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Complication-Free Rate (CFR)	Complication is any device-or-procedure related serious adverse event, or serious adverse device effect, including those that prevented initial implantation. Complications possibly related or related to COVID-19 were excluded. Percentage of participants free from complications are reported	6 weeks
Complication-Free Rate (CFR)	Complication is any device-or-procedure related serious adverse event, or serious adverse device effect, including those that prevented initial implantation. Complications possibly related or related to COVID-19 were excluded. The complication free rate reported describes the Kaplan-Meier estimate of the percentage of patients that had no complications at the given time point.	12 months
Pacing Thresholds and R-wave Amplitudes Within the Therapeutic Range	Success Rate is percentage of subjects who have acceptable pacing threshold and sensing amplitudes, which are defined as pacing threshold <=2.0V at 0.4 ms pulse width and R-wave amplitude =>5.0 mV or => value at implant.	6 Weeks (Aveir VR Leadless Pacemaker arm)
Pacing Thresholds and R-wave Amplitudes Within the Therapeutic Range	Success Rate is percentage of subjects who have acceptable pacing threshold and sensing amplitudes at 12-Month post-implant visit, which are defined as pacing threshold <=2.0V at 0.4 ms pulse width and R-wave amplitude =>5.0 mV or => value at implant.	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Appropriate and Proportional Rate Response During Graded Exercise Testing	Temperature-based rate response feature was evaluated to determine whether an appropriate and proportional rate response was achieved during maximal effort graded treadmill exercise testing protocol (CAEP). Subjects were asked to perform a six-minute walk test to identify optimal sensor parameters prior to conducting a CAEP test. Exercise test data provide an estimate of the slope of the normalized increase in sensor-indicated rate versus normalized workload for each subject. Normalizing a variable eliminates the unit. Since both axes are normalized, there is no unit of measure. The vertical axis is derived from the difference of the sensor indicated rate at each exercise stage and the base rate, divided by the difference of the age-predicted maximum heart rate and base rate. Values on the horizontal axis are derived from the difference in the workload at each exercise stage and resting workload, divided by the difference of the maximum achieved workload and resting workload.	3 month follow up
Survival Rate of Patients Implanted With the Nanostim Leadless Pacemaker	All-Cause Mortality through 2 years among subjects implanted with the Nanostim Leadless Pacemaker. The Nanostim Leadless Pacemaker is functionally similar to the Aveir VR Leadless Pacemaker, and was evaluated in The LEADLESS II IDE Study (Phase I) - NCT02030418. For detailed demographic and study information including adverse events, refer to NCT02030418	2 years

Collaborators and Investigators

• Sponsor: Abbott Medical Devices
• Investigators: Study Director: Nicole Harbert, Abbott

Publications and helpful links

General Publications

• Reddy VY, Exner DV, Doshi R, Tomassoni G, Bunch TJ, Friedman P, Estes NAM, Neuzil P, de la Concha JF, Cantillon DJ; LEADLESS II Investigators. 1-Year Outcomes of a Leadless Ventricular Pacemaker: The LEADLESS II (Phase 2) Trial. JACC Clin Electrophysiol. 2023 Jul;9(7 Pt 2):1187-1189. doi: 10.1016/j.jacep.2023.01.031. Epub 2023 Mar 22. No abstract available.

Study record dates

Study Major Dates

• Study Start (Actual): November 13, 2020
• Primary Completion (Actual): July 18, 2022
• Study Completion (Actual): September 15, 2023

Study Registration Dates

• First Submitted: September 17, 2020
• First Submitted That Met QC Criteria: September 17, 2020
• First Posted (Actual): September 23, 2020

Study Record Updates

• Last Update Posted (Actual): May 20, 2026
• Last Update Submitted That Met QC Criteria: May 18, 2026
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Keywords: Pacemaker; Bradycardia; Leadless
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Pathological Conditions, Signs and Symptoms; Bradycardia; Arrhythmias, Cardiac
• Other Study ID Numbers: ABT-CIP-10355

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: Yes