Aveir DR i2i Study

Aveir Dual-Chamber Leadless i2i IDE Study

Prospective, non-randomized, multi-center, international study designed to evaluate the safety and effectiveness of the Aveir™ Dual-Chamber (DR) Leadless Pacemaker system.

Study Overview

• Status: Active, not recruiting
• Conditions: Bradycardia; Cardiac Pacemaker, Artificial; Cardiac Rhythm Disorder
• Intervention / Treatment: Device: Aveir DR Leadless Pacemaker System

Detailed Description

The purpose of this clinical investigation is to evaluate the clinical safety and effectiveness of the Aveir DR Leadless Pacemaker system in a patient population indicated for a DDD(R) pacemaker.

Subjects participating in the study are followed through at least 12 months with data collected at baseline, implant procedure, pre (hospital) discharge, and follow-up at 1 month, 3 months, 6 months, 12 months, and every 6 months thereafter until study completion

• Study Type: Interventional
• Enrollment (Actual): 500
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Binh Ngo; Phone Number: 8184932060; Email: binh.ngo1@abbott.com
• Study Contact Backup: Name: Mariah Tackett; Email: mariah.tackett@abbott.com

Study Locations

• Austria
  • Upper Austria
    • Linz, Upper Austria, Austria, 4021
      • Kepler Universitätsklinikum GmbH
• Belgium
  • Flemish Brabant
    • Leuven, Flemish Brabant, Belgium, 3000
      • Uz Gasthuisberg
• Canada
  • Alberta
    • Calgary, Alberta, Canada, T2N 4N1
      • Foothills Medical Centre
  • Newfoundland and Labrador
    • Saint John's, Newfoundland and Labrador, Canada, A1B 3V6
      • HSC, Eastern Health
  • Nova Scotia
    • Halifax, Nova Scotia, Canada, B3H 3A7
      • QE II Health Sciences
  • Ontario
    • Newmarket, Ontario, Canada, L3Y2P9
      • Southlake Regional Health Centre
  • Quebec
    • Montréal, Quebec, Canada
      • Institut de Cardiologie de Montreal (Montreal Heart Inst.)
• Czechia
  • Prague, Czechia
    • Nemocnice Na Homolce
• France
  • Grenoble, France, 38043
    • CHRU Albert Michallon
  • Alpes
    • Marseille, Alpes, France, 13005
      • Hopital d'adulte de la Timone
• Hong Kong
  • Hong Kong, Hong Kong, HK SAR
    • Queen Mary Hospital
  • Hk Sar
    • Hong Kong, Hk Sar, Hong Kong
      • Prince of Wales Hospital
• Italy
  • Milano, Italy, 20138
    • Centro Cardiologico Monzino
  • Pisa, Italy, 56100
    • Azienda Ospedaliero Universitaria Pisana
• Japan
  • Tokyo, Japan
    • Tokyo Women's Medical University
  • Fukuoka
    • Kitakyushu, Fukuoka, Japan
      • Kokura Memorial Hospital
  • Okayama
    • Kurashiki-shi, Okayama, Japan
      • Kurashiki Central Hospital
  • Osaka
    • Suita, Osaka, Japan
      • National Cerebral & Cardiovascular Center Hospital
• Netherlands
  • Amsterdam, Netherlands, 1105 AZ
    • Amsterdam Academic Medical Centre (AMC)
• Spain
  • Barcelona, Spain, 08036
    • Hospital Clínic de Barcelona
  • Extmdra
    • Badajoz, Extmdra, Spain, 06080
      • Hospital Universitario de Badajoz
• Taiwan
  • Taipei, Taiwan
    • National Taiwan University Hospital
• United Kingdom
  • London, United Kingdom, SW3 6NP
    • Royal Brompton Hospital
  • Soeast
    • Oxford, Soeast, United Kingdom, OX3 9DU
      • John Radcliffe Hospital
• United States
  • Arizona
    • Scottsdale, Arizona, United States, 85258
      • Honorhealth
  • Arkansas
    • Jonesboro, Arkansas, United States, 72401
      • Arrhythmia Research Group
    • Little Rock, Arkansas, United States, 72211
      • Arkansas Heart Hospital
  • California
    • Los Angeles, California, United States, 90048
      • Cedars-Sinai Medical Center
    • Los Angeles, California, United States, 90027
      • Kaiser Permanente Los Angeles Medical Center
    • Los Angeles, California, United States, 90033
      • USC University Hospital
    • Newport Beach, California, United States, 92663
      • Premier Cardiology, Inc
    • Orange, California, United States, 92868
      • Providence Medical Foundation
    • Pasadena, California, United States, 91105
      • Huntington Memorial Hospital
    • San Diego, California, United States, 92118-8411
      • University of California at San Diego (UCSD) Medical Center
    • Santa Monica, California, United States, 90404
      • Pacific Heart Institute
  • Colorado
    • Littleton, Colorado, United States, 80120
      • South Denver Cardiology Associates PC
  • District of Columbia
    • Washington, District of Columbia, United States, 20010
      • Washington Hospital Center
  • Florida
    • Jacksonville, Florida, United States, 32207
      • Baptist Medical Center
    • Naples, Florida, United States, 34119
      • Naples Heart Rhythm Specialists, PA
    • Orlando, Florida, United States, 32803
      • AdventHealth Orlando
    • Sarasota, Florida, United States, 34239
      • Sarasota Memorial Hospital
  • Georgia
    • Atlanta, Georgia, United States, 30309
      • Piedmont Heart Institute
    • Atlanta, Georgia, United States, 30342
      • Emory University Hospital
  • Illinois
    • Chicago, Illinois, United States, 60612
      • Rush University Medical Center
    • Springfield, Illinois, United States, 62769
      • Prairie Education & Research Cooperative
  • Iowa
    • West Des Moines, Iowa, United States, 50266
      • Iowa Heart Center
  • Kentucky
    • Lexington, Kentucky, United States, 40503
      • Baptist Health Lexington
  • Massachusetts
    • Fall River, Massachusetts, United States, 02720
      • Charlton Memorial Hospital
  • Michigan
    • Lansing, Michigan, United States, 48912
      • Sparrow Clinical Research Institute
    • Southfield, Michigan, United States, 48075
      • Providence Hospital
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic
  • Nebraska
    • Lincoln, Nebraska, United States, 68506
      • Bryan Heart
  • New Hampshire
    • Manchester, New Hampshire, United States, 03102
      • Catholic Medical Center
  • New Jersey
    • Ocean City, New Jersey, United States, 07712
      • Jersey Shore University Medical Center
  • New York
    • Manhasset, New York, United States, 11030
      • North Shore University Hospital
    • New York, New York, United States, 10016
      • New York University Hospital
    • New York, New York, United States, 10029
      • Mount Sinai Hospital
    • New York, New York, United States, 10032
      • New York-Presbyterian/Columbia University Medical Center
    • 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
    • Winston-Salem, North Carolina, United States, 27157
      • Wake Forest University Medical Center Clinical Sciences
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • The Cleveland Clinic Foundation
    • Columbus, Ohio, United States, 43214
      • Ohio Health Research Institute
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73102
      • Hightower Clinical
    • Oklahoma City, Oklahoma, United States, 73135
      • Oklahoma Heart Hospital South
  • Oregon
    • Portland, Oregon, United States, 97225
      • Providence St. Vincent Medical Center
  • Pennsylvania
    • Lancaster, Pennsylvania, United States, 17602
      • Lancaster General Hospital
    • Pittsburgh, Pennsylvania, United States, 15213
      • University of Pittsburgh Medical Center
    • Sayre, Pennsylvania, United States, 18840
      • Donald Guthrie Foundation for Education & Research
  • South Dakota
    • Sioux Falls, South Dakota, United States, 57104
      • Sanford USD Medical Center
  • Tennessee
    • Nashville, Tennessee, United States, 37232
      • Vanderbilt Heart & Vascular Institute
  • Texas
    • Austin, Texas, United States, 78705
      • Texas Cardiac Arrhythmia
    • 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
  • Washington
    • Tacoma, Washington, United States, 98405
      • Franciscan Heart & Vascular Associates
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53215
      • Aurora Medical Group
    • Wausau, Wisconsin, United States, 54401
      • Aspirus Wausau 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 at least one of the clinical indications before device implant in adherence with ACC/AHA/HRS/ESC dual chamber pacing guidelines
2. Subject is ≥ 18 years of age or age of legal consent, whichever age is greater
3. Subject has a life expectancy of at least one year
4. Subject is willing to comply with clinical investigation procedures and agrees to return to clinic for all required follow-up visits, tests, and exams
5. Subject has been informed of the nature of the clinical investigation, agrees to its provisions and has provided a signed written informed consent, approved by the IRB/EC

Exclusion Criteria:

1. Subject is currently participating in another clinical investigation that may confound the results of this study as determined by the Sponsor
2. Subject is pregnant or nursing and those who plan pregnancy during the clinical investigation follow-up period
3. Subject has presence of anatomic or comorbid conditions, or other medical, social, or psychological conditions that, in the investigator's opinion, could confound the assessment of the investigational device and/or implant procedure, limit the subject's ability to participate in the clinical investigation or to comply with follow-up requirements of the clinical investigation results
4. Subject has a known allergy or hypersensitivity to < 1 mg of dexamethasone sodium phosphate or any blood or tissue contacting material listed in the IFU
5. Subject has an implanted vena cava filter or mechanical tricuspid valve prosthesis
6. Subject has pre-existing, permanent endocardial pacing or defibrillation leads (does not include lead fragments)
7. Subject has current implantation of either conventional or subcutaneous implantable cardioverter defibrillator (ICD) or cardiac resynchronization therapy (CRT) device
8. Subject has an implanted leadless cardiac pacemaker (except for an Aveir ventricular leadless pacemaker)
9. Subject is implanted with an electrically-active implantable medical device with stimulation capabilities (such as neurological or cardiac stimulators)
10. Subject is unable to read or write

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
Other: Single Arm; Non randomized arm	Device: Aveir DR Leadless Pacemaker System; Patients will undergo a dual chamber leadless pacemaker system implant wherein a leadless pacemaker will be implanted in the right ventricle and right atrium

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Subjects Free from Aveir DR System-Related Complications	Aveir DR Leadless Pacemaker system complication-free-rate in de novo subjects	3 months
Number of Subjects Free from Aveir DR System-Related Complications	Aveir DR Leadless Pacemaker system complication-free-rate in de novo subjects	12 months
Percentage of Subjects with Acceptable Atrial Threshold and Amplitude Measurements	Composite success rate of acceptable atrial pacing thresholds and P-wave amplitudes in de novo subjects	3 months
Percentage of Subjects with Acceptable Atrial Threshold and Amplitude Measurements	Composite success rate of acceptable atrial pacing thresholds and P-wave amplitudes in de novo subjects	12 months
Percentage of Subjects with a Ventricular Beat Followed by an Atrial Beat	AV synchrony success rate at rest while seated in de novo subjects defined as the percentage of subjects with a ventricular paced or sensed beat followed by an atrial paced or sensed beat.	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Subjects Free from Aveir Atrial Leadless Pacemaker-Related Complications	Aveir Atrial Leadless Pacemaker complication-free-rate in de novo subjects	3 months
Number of Subjects Free from Aveir Atrial Leadless Pacemaker-Related Complications	Aveir Atrial Leadless Pacemaker complication-free-rate in de novo subjects	12 months
Appropriate Rate Response of the Aveir Atrial Leadless Pacemaker During Exercise Testing	Appropriate and proportional rate response of the Aveir Atrial Leadless Pacemaker in de novo subjects during graded exercise testing	3 months

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): February 2, 2022
• Primary Completion (Actual): August 2, 2023
• Study Completion (Estimated): November 1, 2025

Study Registration Dates

• First Submitted: February 9, 2022
• First Submitted That Met QC Criteria: February 17, 2022
• First Posted (Actual): February 23, 2022

Study Record Updates

• Last Update Posted (Actual): February 2, 2024
• Last Update Submitted That Met QC Criteria: February 1, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Pacemaker; Bradycardia; Vasovagal Syncope; Sick Sinus Syndrome; AV Block
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Bradycardia; Arrhythmias, Cardiac
• Other Study ID Numbers: ABT-CIP-10416

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Any de-identified individual participant data collected will be shared with investigators or other study committee members whose proposed use of the data has been approved by the Aveir DR i2i Study Steering Committee.
• IPD Sharing Time Frame: IPD will be available following publication of primary results for 25 years following study completion date.
• IPD Sharing Access Criteria: Proposals for requesting individual data may be submitted to the Sponsor at AveirDR_IDE@abbott.com.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes