Aveir DR i2i Study

Study Overview
=================
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

Official Title
-----------------
Aveir Dual-Chamber Leadless i2i IDE Study

Conditions
-----------------
Cardiac Pacemaker, Artificial, Cardiac Rhythm Disorder, Bradycardia

Intervention / Treatment
-----------------
* Device: Aveir DR Leadless Pacemaker System


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Prospective, multi-center, international, single-arm, pivotal investigational study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Single Arm<br>Non randomized arm | Device: Aveir DR Leadless Pacemaker System<br>* Patients will undergo a dual chamber leadless pacemaker system implant wherein a leadless pacemaker will be implanted in the right ventricle and right atrium<br>|

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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Bradycardia, Sick Sinus Syndrome, Pacemaker, AV Block, Vasovagal Syncope