Aveir DR i2i Study

Not Applicable

Active, not recruiting

Conditions: Cardiac Pacemaker, Artificial
Cardiac Rhythm Disorder
Bradycardia

Interventions: Device: Aveir DR Leadless Pacemaker System

Registration Number: NCT05252702

Lead Sponsor: Abbott Medical Devices

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

Recruitment & Eligibility

Status: ACTIVE_NOT_RECRUITING

Sex: All

Target Recruitment: 464

Inclusion Criteria

Subject must have at least one of the clinical indications before device implant in adherence with ACC/AHA/HRS/ESC dual chamber pacing guidelines
Subject is ≥ 18 years of age or age of legal consent, whichever age is greater
Subject has a life expectancy of at least one year
Subject is willing to comply with clinical investigation procedures and agrees to return to clinic for all required follow-up visits, tests, and exams
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

Subject is currently participating in another clinical investigation that may confound the results of this study as determined by the Sponsor
Subject is pregnant or nursing and those who plan pregnancy during the clinical investigation follow-up period
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
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
Subject has an implanted vena cava filter or mechanical tricuspid valve prosthesis
Subject has pre-existing, permanent endocardial pacing or defibrillation leads (does not include lead fragments)
Subject has current implantation of either conventional or subcutaneous implantable cardioverter defibrillator (ICD) or cardiac resynchronization therapy (CRT) device
Subject has an implanted leadless cardiac pacemaker (except for an Aveir ventricular leadless pacemaker)
Subject is implanted with an electrically-active implantable medical device with stimulation capabilities (such as neurological or cardiac stimulators)
Subject is unable to read or write

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Single Arm	Aveir DR Leadless Pacemaker System	Non randomized arm

Primary Outcome Measures

Name	Time	Method
Percentage of Participants Free From Aveir DR System-Related Complications at 3-months	3 months	Aveir DR Leadless Pacemaker system complication-free-rate in de novo subjects. A complication was defined as a device-or-procedure-related serious adverse event. Complications included Atrial LP, Ventricular LP, and implant procedure-related complications. Complications possibly related or related to COVID-19 were excluded.
Percentage of Participants Free From Aveir DR System-Related Complications at 12-months	12 months	Aveir DR Leadless Pacemaker system complication-free-rate in de novo subjects. A complication was defined as a device-or-procedure-related serious adverse event. Complications included Atrial LP, Ventricular LP, and implant procedure-related complications. Complications possibly related or related to COVID-19 were excluded.
Percentage of Subjects With Acceptable Atrial Threshold and Amplitude Measurements at 3-months	3 months	Composite success rate of acceptable atrial pacing thresholds and P-wave amplitudes in de novo subjects. A subject was considered to have met the primary effectiveness endpoint #1 if the pacing threshold voltage was ≤ 3.0 V at 0.4 ms at the 3-month visit and the sensed P-wave amplitude was ≥ 1.0 mV at the 3-month visit.
Percentage of Subjects With Acceptable Atrial Threshold and Amplitude Measurements at 12-months	12 months	Composite success rate of acceptable atrial pacing thresholds and P-wave amplitudes in de novo subjects. A subject was considered to have met the success criteria for the endpoint if the pacing threshold voltage was ≤ 3.0 V at 0.4 ms at the 12-month visit and the sensed P-wave amplitude was ≥ 1.0 mV at the 12-month visit.
Percentage of Participants With AV Synchrony Success Rate at Rest While Seated	3 months	AV synchrony success was defined as subjects with a paced or sensed ventricular beat within 300 ms following a paced or sensed atrial beat (i.e., a synchronous cycle) for at least 70% of evaluable cardiac cycles.

Secondary Outcome Measures

Name	Time	Method
Percentage of Participants Free From Aveir Atrial Leadless Pacemaker-Related Complications at 12-months	12 months	The secondary safety endpoint analysis evaluated the 12-month Atrial LP related complication-free rate (CFRA) based on CEC adjudication of adverse events. An Atrial LP complication was defined as an atrial device-or-procedure-related serious adverse event. Complications that were exclusively related to the Ventricular LP or its delivery/retrieval were not considered Atrial LP complications and were excluded from the evaluation. For a conservative approach, complications that could not exclusively be determined to be related to the ventricular or Atrial LP were still considered Atrial LP complications. For example, procedure-related femoral access complications were adjudicated as Atrial LP complications. Complications possibly related or related to COVID-19 were excluded.
Slope of the Normalized Increase in the Sensor Indicated Rate Versus Normalized Workload of the Aveir Atrial Leadless Pacemaker During Exercise Testing	3 months	Appropriate and proportional rate response of the Aveir Atrial Leadless Pacemaker in de novo subjects was tested during staged exercise testing. Exercise test data provided 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 and expresses it from 0-1.0. Since both axes are normalized sensor rate and workload, there is no distinct unit of measure. Values on the vertical axis are 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. A slope value of 1.0 indicates the pacemaker's sensor-indicated rate increases linearly with an increase in workload.
Percentage of Participants Free From Aveir Atrial Leadless Pacemaker-Related Complications at 3-months	3 months	The secondary safety endpoint evaluated a 3-month Atrial LP related complication-free rate based on CEC adjudication of adverse events. An Atrial LP complication was defined as an atrial device-or-procedure-related serious adverse event. Complications that were exclusively related to the Ventricular LP or its delivery/retrieval were not considered Atrial LP complications and were excluded from the evaluation. For a conservative approach, complications that could not exclusively be determined to be related to the ventricular or Atrial LP were still considered Atrial LP complications. For example, procedure-related femoral access complications were adjudicated as Atrial LP complications.

Trial Locations

Locations (78): Kaiser Permanente Los Angeles Medical Center
🇺🇸
Los Angeles, California, United States
USC University Hospital
🇺🇸
Los Angeles, California, United States
Charlton Memorial Hospital
🇺🇸
Fall River, Massachusetts, United States
Donald Guthrie Foundation for Education & Research
🇺🇸
Sayre, Pennsylvania, United States
Rush University Medical Center
🇺🇸
Chicago, Illinois, United States
Ohio Health Research Institute
🇺🇸
Columbus, Ohio, United States
Texas Cardiac Arrhythmia
🇺🇸
Austin, Texas, United States
Sanford USD Medical Center
🇺🇸
Sioux Falls, South Dakota, United States
Cardiac Arrhythmia & Pacemaker Center
🇺🇸
Roslyn, New York, United States
New York-Presbyterian/Columbia University Medical Center
🇺🇸
New York, New York, United States
Franciscan Heart & Vascular Associates
🇺🇸
Tacoma, Washington, United States
Wake Forest University Medical Center Clinical Sciences
🇺🇸
Winston-Salem, North Carolina, United States
Kokura Memorial Hospital
🇯🇵
Kitakyushu, Fukuoka, Japan
Southlake Regional Health Centre
🇨🇦
Newmarket, Ontario, Canada
Memorial Hermann Hospital
🇺🇸
The Woodlands, Texas, United States
University of Pittsburgh Medical Center
🇺🇸
Pittsburgh, Pennsylvania, United States
Nemocnice Na Homolce
🇨🇿
Prague, Czechia
The Cleveland Clinic Foundation
🇺🇸
Cleveland, Ohio, United States
Centro Cardiologico Monzino
🇮🇹
Milano, Italy
National Cerebral & Cardiovascular Center Hospital
🇯🇵
Suita, Osaka, Japan
Tokyo Women's Medical University
🇯🇵
Tokyo, Japan
Amsterdam Academic Medical Centre (AMC)
🇳🇱
Amsterdam, Netherlands
Hospital Universitario de Badajoz
🇪🇸
Badajoz, Extmdra, Spain
Hopital d'adulte de la Timone
🇫🇷
Marseille, Alpes, France
Aspirus Wausau Hospital
🇺🇸
Wausau, Wisconsin, United States
Foothills Medical Centre
🇨🇦
Calgary, Alberta, Canada
UZ Gasthuisberg
🇧🇪
Leuven, Flemish Brabant, Belgium
Kepler Universitätsklinikum GmbH
🇦🇹
Linz, Upper Austria, Austria
Emory University Hospital
🇺🇸
Atlanta, Georgia, United States
HSC, Eastern Health
🇨🇦
Saint John's, Newfoundland and Labrador, Canada
Huntington Memorial Hospital
🇺🇸
Pasadena, California, United States
University of California at San Diego (UCSD) Medical Center
🇺🇸
San Diego, California, United States
Mayo Clinic
🇺🇸
Rochester, Minnesota, United States
Hightower Clinical
🇺🇸
Oklahoma City, Oklahoma, United States
Oklahoma Heart Hospital South
🇺🇸
Oklahoma City, Oklahoma, United States
Providence St. Vincent Medical Center
🇺🇸
Portland, Oregon, United States
Vanderbilt Heart & Vascular Institute
🇺🇸
Nashville, Tennessee, United States
South Texas Cardiovascular Consultants
🇺🇸
San Antonio, Texas, United States
University of Utah Hospital
🇺🇸
Salt Lake City, Utah, United States
CHRU Albert Michallon
🇫🇷
Grenoble, France
Aurora Medical Group
🇺🇸
Milwaukee, Wisconsin, United States
National Taiwan University Hospital
🇨🇳
Taipei, Taiwan
Lancaster General Hospital
🇺🇸
Lancaster, Pennsylvania, United States
Arrhythmia Research Group
🇺🇸
Jonesboro, Arkansas, United States
HonorHealth
🇺🇸
Scottsdale, Arizona, United States
Arkansas Heart Hospital
🇺🇸
Little Rock, Arkansas, United States
Cedars-Sinai Medical Center
🇺🇸
Los Angeles, California, United States
Providence Medical Foundation
🇺🇸
Orange, California, United States
Pacific Heart Institute
🇺🇸
Santa Monica, California, United States
South Denver Cardiology Associates PC
🇺🇸
Littleton, Colorado, United States
Naples Heart Rhythm Specialists, PA
🇺🇸
Naples, Florida, United States
Washington Hospital Center
🇺🇸
Washington, District of Columbia, United States
Baptist Medical Center
🇺🇸
Jacksonville, Florida, United States
AdventHealth Orlando
🇺🇸
Orlando, Florida, United States
Sarasota Memorial Hospital
🇺🇸
Sarasota, Florida, United States
Piedmont Heart Institute
🇺🇸
Atlanta, Georgia, United States
Prairie Education & Research Cooperative
🇺🇸
Springfield, Illinois, United States
Iowa Heart Center
🇺🇸
West Des Moines, Iowa, United States
Baptist Health Lexington
🇺🇸
Lexington, Kentucky, United States
Providence Hospital
🇺🇸
Southfield, Michigan, United States
Sparrow Clinical Research Institute
🇺🇸
Lansing, Michigan, United States
Bryan Heart
🇺🇸
Lincoln, Nebraska, United States
Jersey Shore University Medical Center
🇺🇸
Ocean City, New Jersey, United States
North Shore University Hospital
🇺🇸
Manhasset, New York, United States
Catholic Medical Center
🇺🇸
Manchester, New Hampshire, United States
New York University Hospital
🇺🇸
New York, New York, United States
New York Presbyterian Hospital/Cornell University
🇺🇸
New York, New York, United States
Mount Sinai Hospital
🇺🇸
New York, New York, United States
QE II Health Sciences
🇨🇦
Halifax, Nova Scotia, Canada
Institut de Cardiologie de Montreal (Montreal Heart Inst.)
🇨🇦
Montréal, Quebec, Canada
Azienda Ospedaliero Universitaria Pisana
🇮🇹
Pisa, Italy
Kurashiki Central Hospital
🇯🇵
Kurashiki-shi, Okayama, Japan
Hospital Clínic de Barcelona
🇪🇸
Barcelona, Spain
John Radcliffe Hospital
🇬🇧
Oxford, Soeast, United Kingdom
Premier Cardiology, Inc
🇺🇸
Newport Beach, California, United States
Royal Brompton Hospital
🇬🇧
London, United Kingdom
Prince of Wales Hospital
🇭🇰
Hong Kong, Hk Sar, Hong Kong
Queen Mary Hospital
🇭🇰
Hong Kong, Hong Kong