Aveir DR i2i Study

Bradycardia Clinical Trial

Official title:

Aveir Dual-Chamber Leadless i2i IDE Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05252702
• Other study ID #: ABT-CIP-10416
• Status: Active, not recruiting
• Phase: N/A
• Start date: February 2, 2022
• Est. completion date: November 2025

Study information

• Verified date: June 2024
• Source: Abbott Medical Devices
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 500
• Est. completion date: November 2025
• Est. primary completion date: August 2, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arrhythmias, Cardiac
• Bradycardia
• Cardiac Pacemaker, Artificial
• Cardiac Rhythm Disorder

Intervention

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

Locations

Country	Name	City	State
Austria	Kepler Universitätsklinikum GmbH	Linz	Upper Austria
Belgium	UZ Gasthuisberg	Leuven	Flemish Brabant
Canada	Foothills Medical Centre	Calgary	Alberta
Canada	QE II Health Sciences	Halifax	Nova Scotia
Canada	Institut de Cardiologie de Montreal (Montreal Heart Inst.)	Montréal	Quebec
Canada	Southlake Regional Health Centre	Newmarket	Ontario
Canada	HSC, Eastern Health	Saint John's	Newfoundland and Labrador
Czechia	Nemocnice Na Homolce	Prague
France	CHRU Albert Michallon	Grenoble
France	Hopital d'adulte de la Timone	Marseille	Alpes
Hong Kong	Prince of Wales Hospital	Hong Kong	Hk Sar
Hong Kong	Queen Mary Hospital	Hong Kong
Italy	Centro Cardiologico Monzino	Milano
Italy	Azienda Ospedaliero Universitaria Pisana	Pisa
Japan	Kokura Memorial Hospital	Kitakyushu	Fukuoka
Japan	Kurashiki Central Hospital	Kurashiki-shi	Okayama
Japan	National Cerebral & Cardiovascular Center Hospital	Suita	Osaka
Japan	Tokyo Women's Medical University	Tokyo
Netherlands	Amsterdam Academic Medical Centre (AMC)	Amsterdam
Spain	Hospital Universitario de Badajoz	Badajoz	Extmdra
Spain	Hospital Clínic de Barcelona	Barcelona
Taiwan	National Taiwan University Hospital	Taipei
United Kingdom	Royal Brompton Hospital	London
United Kingdom	John Radcliffe Hospital	Oxford	Soeast
United States	Emory University Hospital	Atlanta	Georgia
United States	Piedmont Heart Institute	Atlanta	Georgia
United States	Texas Cardiac Arrhythmia	Austin	Texas
United States	Rush University Medical Center	Chicago	Illinois
United States	The Cleveland Clinic Foundation	Cleveland	Ohio
United States	Ohio Health Research Institute	Columbus	Ohio
United States	Charlton Memorial Hospital	Fall River	Massachusetts
United States	Baptist Medical Center	Jacksonville	Florida
United States	Arrhythmia Research Group	Jonesboro	Arkansas
United States	Lancaster General Hospital	Lancaster	Pennsylvania
United States	Sparrow Clinical Research Institute	Lansing	Michigan
United States	Baptist Health Lexington	Lexington	Kentucky
United States	Bryan Heart	Lincoln	Nebraska
United States	Arkansas Heart Hospital	Little Rock	Arkansas
United States	South Denver Cardiology Associates PC	Littleton	Colorado
United States	Cedars-Sinai Medical Center	Los Angeles	California
United States	Kaiser Permanente Los Angeles Medical Center	Los Angeles	California
United States	USC University Hospital	Los Angeles	California
United States	Catholic Medical Center	Manchester	New Hampshire
United States	North Shore University Hospital	Manhasset	New York
United States	Aurora Medical Group	Milwaukee	Wisconsin
United States	Naples Heart Rhythm Specialists, PA	Naples	Florida
United States	Vanderbilt Heart & Vascular Institute	Nashville	Tennessee
United States	Mount Sinai Hospital	New York	New York
United States	New York Presbyterian Hospital/Cornell University	New York	New York
United States	New York University Hospital	New York	New York
United States	New York-Presbyterian/Columbia University Medical Center	New York	New York
United States	Premier Cardiology, Inc	Newport Beach	California
United States	Jersey Shore University Medical Center	Ocean City	New Jersey
United States	Hightower Clinical	Oklahoma City	Oklahoma
United States	Oklahoma Heart Hospital South	Oklahoma City	Oklahoma
United States	Providence Medical Foundation	Orange	California
United States	AdventHealth Orlando	Orlando	Florida
United States	Huntington Memorial Hospital	Pasadena	California
United States	University of Pittsburgh Medical Center	Pittsburgh	Pennsylvania
United States	Providence St. Vincent Medical Center	Portland	Oregon
United States	Mayo Clinic	Rochester	Minnesota
United States	Cardiac Arrhythmia & Pacemaker Center	Roslyn	New York
United States	University of Utah Hospital	Salt Lake City	Utah
United States	South Texas Cardiovascular Consultants	San Antonio	Texas
United States	University of California at San Diego (UCSD) Medical Center	San Diego	California
United States	Pacific Heart Institute	Santa Monica	California
United States	Sarasota Memorial Hospital	Sarasota	Florida
United States	Donald Guthrie Foundation for Education & Research	Sayre	Pennsylvania
United States	HonorHealth	Scottsdale	Arizona
United States	Sanford USD Medical Center	Sioux Falls	South Dakota
United States	Providence Hospital	Southfield	Michigan
United States	Prairie Education & Research Cooperative	Springfield	Illinois
United States	Franciscan Heart & Vascular Associates	Tacoma	Washington
United States	Memorial Hermann Hospital	The Woodlands	Texas
United States	Washington Hospital Center	Washington	District of Columbia
United States	Aspirus Wausau Hospital	Wausau	Wisconsin
United States	Iowa Heart Center	West Des Moines	Iowa
United States	Wake Forest University Medical Center Clinical Sciences	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Abbott Medical Devices

Countries where clinical trial is conducted

United States,  Austria,  Belgium,  Canada,  Czechia,  France,  Hong Kong,  Italy,  Japan,  Netherlands,  Spain,  Taiwan,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Subjects Free from Aveir DR System-Related Complications	Aveir DR Leadless Pacemaker system complication-free-rate in de novo subjects	3 months
Primary	Number of Subjects Free from Aveir DR System-Related Complications	Aveir DR Leadless Pacemaker system complication-free-rate in de novo subjects	12 months
Primary	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
Primary	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
Primary	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	Number of Subjects Free from Aveir Atrial Leadless Pacemaker-Related Complications	Aveir Atrial Leadless Pacemaker complication-free-rate in de novo subjects	3 months
Secondary	Number of Subjects Free from Aveir Atrial Leadless Pacemaker-Related Complications	Aveir Atrial Leadless Pacemaker complication-free-rate in de novo subjects	12 months
Secondary	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