Aveir DR i2i Study

Not Applicable

Active, not recruiting

• Conditions: Cardiac Pacemaker, Artificial; Cardiac Rhythm Disorder; Bradycardia

• 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

Study Timeline

• Study Start: 2022-02-02
• Study First Submitted: 2022-02-09
• Study First Submitted QC: 2022-02-17
• Study First Posted: 2022-02-23
• Primary Completion: 2023-08-02
• Status Verified: 2024-06
• Results First Submitted: 2024-08-01
• Results First Submitted QC: 2024-11-01
• Last Update Submitted: 2024-11-01
• Results First Posted: 2024-11-05
• Last Update Posted: 2024-11-05
• Study Completion: 2025-11

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 464

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

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)

HonorHealth; 🇺🇸 Scottsdale, Arizona, United States

Arrhythmia Research Group; 🇺🇸 Jonesboro, Arkansas, United States

Arkansas Heart Hospital; 🇺🇸 Little Rock, Arkansas, United States

Kaiser Permanente Los Angeles Medical Center; 🇺🇸 Los Angeles, California, United States

USC University Hospital; 🇺🇸 Los Angeles, California, United States

Cedars-Sinai Medical Center; 🇺🇸 Los Angeles, California, United States

Premier Cardiology, Inc; 🇺🇸 Newport Beach, California, United States

Providence Medical Foundation; 🇺🇸 Orange, California, United States

Huntington Memorial Hospital; 🇺🇸 Pasadena, California, United States

University of California at San Diego (UCSD) Medical Center; 🇺🇸 San Diego, California, United States

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