Clinical trial NCT05252702: Aveir DR i2i Study
Official title: Aveir Dual-Chamber Leadless i2i IDE Study
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Cardiac Pacemaker, Artificial
Cardiac Rhythm Disorder
Bradycardia
Keywords: Bradycardia
Sick Sinus Syndrome
Pacemaker
AV Block
Vasovagal Syncope
Lead sponsor: Abbott Medical Devices
Sponsor class: INDUSTRY
First posted: 2022-02-23
Enrollment: 464
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Prospective, multi-center, international, single-arm, pivotal investigational study
Primary purpose: TREATMENT

Brief summary: Prospective, non-randomized, multi-center, international study designed to evaluate the safety and effectiveness of the Aveir™ Dual-Chamber (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

Eligibility criteria: 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

Primary outcomes:
measure: Percentage of Participants Free From Aveir DR System-Related Complications at 3-months
timeFrame: 3 months
measure: Percentage of Participants Free From Aveir DR System-Related Complications at 12-months
timeFrame: 12 months
measure: Percentage of Subjects With Acceptable Atrial Threshold and Amplitude Measurements at 3-months
timeFrame: 3 months
measure: Percentage of Subjects With Acceptable Atrial Threshold and Amplitude Measurements at 12-months
timeFrame: 12 months
measure: Percentage of Participants With AV Synchrony Success Rate at Rest While Seated
timeFrame: 3 months
Secondary outcomes:
measure: Percentage of Participants Free From Aveir Atrial Leadless Pacemaker-Related Complications at 3-months
timeFrame: 3 months
measure: Percentage of Participants Free From Aveir Atrial Leadless Pacemaker-Related Complications at 12-months
timeFrame: 12 months
measure: Slope of the Normalized Increase in the Sensor Indicated Rate Versus Normalized Workload of the Aveir Atrial Leadless Pacemaker During Exercise Testing
timeFrame: 3 months
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: HonorHealth
state: Arizona
city: Jonesboro
country: United States
facility: Arrhythmia Research Group
state: Arkansas
city: Little Rock
country: United States
facility: Arkansas Heart Hospital
state: Arkansas
city: Los Angeles
country: United States
facility: Kaiser Permanente Los Angeles Medical Center
state: California
city: Los Angeles
country: United States
facility: USC University Hospital
state: California
city: Los Angeles
country: United States
facility: Cedars-Sinai Medical Center
state: California
city: Newport Beach
country: United States
facility: Premier Cardiology, Inc
state: California
city: Orange
country: United States
facility: Providence Medical Foundation
state: California
city: Pasadena
country: United States
facility: Huntington Memorial Hospital
state: California
city: San Diego
country: United States
facility: University of California at San Diego (UCSD) Medical Center
state: California
city: Santa Monica
country: United States
facility: Pacific Heart Institute
state: California
city: Littleton
country: United States
facility: South Denver Cardiology Associates PC
state: Colorado
city: Washington
country: United States
facility: Washington Hospital Center
state: District of Columbia
city: Jacksonville
country: United States
facility: Baptist Medical Center
state: Florida
city: Naples
country: United States
facility: Naples Heart Rhythm Specialists, PA
state: Florida
city: Orlando
country: United States
facility: AdventHealth Orlando
state: Florida
city: Sarasota
country: United States
facility: Sarasota Memorial Hospital
state: Florida
city: Atlanta
country: United States
facility: Piedmont Heart Institute
state: Georgia
city: Atlanta
country: United States
facility: Emory University Hospital
state: Georgia
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
city: Springfield
country: United States
facility: Prairie Education & Research Cooperative
state: Illinois
city: West Des Moines
country: United States
facility: Iowa Heart Center
state: Iowa
city: Lexington
country: United States
facility: Baptist Health Lexington
state: Kentucky
city: Fall River
country: United States
facility: Charlton Memorial Hospital
state: Massachusetts
city: Lansing
country: United States
facility: Sparrow Clinical Research Institute
state: Michigan
city: Southfield
country: United States
facility: Providence Hospital
state: Michigan
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Lincoln
country: United States
facility: Bryan Heart
state: Nebraska
city: Manchester
country: United States
facility: Catholic Medical Center
state: New Hampshire
city: Ocean City
country: United States
facility: Jersey Shore University Medical Center
state: New Jersey
city: Manhasset
country: United States
facility: North Shore University Hospital
state: New York
city: New York
country: United States
facility: New York University Hospital
state: New York
city: New York
country: United States
facility: New York Presbyterian Hospital/Cornell University
state: New York
city: New York
country: United States
facility: Mount Sinai Hospital
state: New York
city: New York
country: United States
facility: New York-Presbyterian/Columbia University Medical Center
state: New York
city: Roslyn
country: United States
facility: Cardiac Arrhythmia & Pacemaker Center
state: New York
city: Winston-Salem
country: United States
facility: Wake Forest University Medical Center Clinical Sciences
state: North Carolina
city: Cleveland
country: United States
facility: The Cleveland Clinic Foundation
state: Ohio
city: Columbus
country: United States
facility: Ohio Health Research Institute
state: Ohio
city: Oklahoma City
country: United States
facility: Hightower Clinical
state: Oklahoma
city: Oklahoma City
country: United States
facility: Oklahoma Heart Hospital South
state: Oklahoma
city: Portland
country: United States
facility: Providence St. Vincent Medical Center
state: Oregon
city: Lancaster
country: United States
facility: Lancaster General Hospital
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center
state: Pennsylvania
city: Sayre
country: United States
facility: Donald Guthrie Foundation for Education & Research
state: Pennsylvania
city: Sioux Falls
country: United States
facility: Sanford USD Medical Center
state: South Dakota
city: Nashville
country: United States
facility: Vanderbilt Heart & Vascular Institute
state: Tennessee
city: Austin
country: United States
facility: Texas Cardiac Arrhythmia
state: Texas
city: San Antonio
country: United States
facility: South Texas Cardiovascular Consultants
state: Texas
city: The Woodlands
country: United States
facility: Memorial Hermann Hospital
state: Texas
city: Salt Lake City
country: United States
facility: University of Utah Hospital
state: Utah
city: Tacoma
country: United States
facility: Franciscan Heart & Vascular Associates
state: Washington
city: Milwaukee
country: United States
facility: Aurora Medical Group
state: Wisconsin
city: Wausau
country: United States
facility: Aspirus Wausau Hospital
state: Wisconsin
city: Linz
country: Austria
facility: Kepler Universitätsklinikum GmbH
state: Upper Austria
city: Leuven
country: Belgium
facility: UZ Gasthuisberg
state: Flemish Brabant
city: Calgary
country: Canada
facility: Foothills Medical Centre
state: Alberta
city: Saint John's
country: Canada
facility: HSC, Eastern Health
state: Newfoundland and Labrador
city: Halifax
country: Canada
facility: QE II Health Sciences
state: Nova Scotia
city: Newmarket
country: Canada
facility: Southlake Regional Health Centre
state: Ontario
city: Montréal
country: Canada
facility: Institut de Cardiologie de Montreal (Montreal Heart Inst.)
state: Quebec
city: Prague
country: Czechia
facility: Nemocnice Na Homolce
city: Marseille
country: France
facility: Hopital d'adulte de la Timone
state: Alpes
city: Grenoble
country: France
facility: CHRU Albert Michallon
city: Hong Kong
country: Hong Kong
facility: Prince of Wales Hospital
state: Hk Sar
city: Hong Kong
country: Hong Kong
facility: Queen Mary Hospital
city: Milano
country: Italy
facility: Centro Cardiologico Monzino
city: Pisa
country: Italy
facility: Azienda Ospedaliero Universitaria Pisana
city: Kitakyushu
country: Japan
facility: Kokura Memorial Hospital
state: Fukuoka
city: Kurashiki-shi
country: Japan
facility: Kurashiki Central Hospital
state: Okayama
city: Suita
country: Japan
facility: National Cerebral & Cardiovascular Center Hospital
state: Osaka
city: Tokyo
country: Japan
facility: Tokyo Women's Medical University
city: Amsterdam
country: Netherlands
facility: Amsterdam Academic Medical Centre (AMC)
city: Badajoz
country: Spain
facility: Hospital Universitario de Badajoz
state: Extmdra
city: Barcelona
country: Spain
facility: Hospital Clínic de Barcelona
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
city: Oxford
country: United Kingdom
facility: John Radcliffe Hospital
state: Soeast
city: London
country: United Kingdom
facility: Royal Brompton Hospital
Study officials:
affiliation: Abbott
name: Nicole Harbert
role: STUDY_DIRECTOR
References: