The LEADLESS II IDE Study for the Aveir VR Leadless Pacemaker System

Not Applicable

Active, not recruiting

• Conditions: Cardiac Rhythm Disorder; Bradycardia

• Registration Number: NCT04559945
• Lead Sponsor: Abbott Medical Devices

Brief Summary

prospective, non-randomized, multi-center, international clinical study is designed to confirm the safety and effectiveness of the Aveir LP System in a subject population indicated for a VVI(R) pacemaker.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-09-17
• Study First Submitted QC: 2020-09-17
• Study First Posted: 2020-09-23
• Study Start: 2020-11-13
• Primary Completion: 2022-07-18
• Status Verified: 2022-12
• Last Update Submitted: 2022-12-16
• Last Update Posted: 2022-12-19
• Study Completion: 2023-08-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 326

Inclusion Criteria

1. Subject must have one of the clinical indications before device implant in adherence with Medicare, ACC/AHA/HRS/ESC single chamber pacing guidelines including:

   • Chronic and/or permanent atrial fibrillation with 2° or 3° AV or bifascicular bundle branch block (BBB block), including slow ventricular rates (with or without medication) associated with atrial fibrillation; or
   • Normal sinus rhythm with 2° or 3° AV or BBB block and a low level of physical activity or short expected lifespan (but at least one year); or
   • Sinus bradycardia with infrequent pauses or unexplained syncope with EP findings; and

2. Subject is ≥18 years of age; and

3. Subject has a life expectancy of at least one year; and

4. Subject is not enrolled in another clinical investigation; and

5. Subject is willing to comply with clinical investigation procedures and agrees to return for all required follow-up visits, tests, and exams; and

6. Subject has been informed of the nature of the study, agrees to its provisions and has provided a signed written informed consent, approved by the IRB/EC; and

7. Subject is not pregnant and does not plan to get pregnant during the course of the study.

Exclusion Criteria

1. Subject has known pacemaker syndrome, has retrograde VA conduction, or suffers a drop in arterial blood pressure with the onset of ventricular pacing; or
2. Subject is allergic or hypersensitive to < 1 mg of dexamethasone sodium phosphate (DSP);
3. Subject has a mechanical tricuspid valve prosthesis; or
4. Subject has a pre-existing endocardial pacing or defibrillation leads; or
5. Subject has current implantation of either conventional or subcutaneous implantable cardioverter defibrillator (ICD) or cardiac resynchronization therapy (CRT) device; or
6. Subject has an implanted vena cava filter; or
7. Subject has evidence of thrombosis in one of the veins used for access during the procedure; or
8. Subject had recent cardiovascular or peripheral vascular surgery within 30 days of enrollment; or
9. Subject has an implanted leadless cardiac pacemaker or
10. Subject is implanted with an electrically-active implantable medical device with stimulation capabilities (such as neurological or cardiac stimulators).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Complication-Free Rate	12 months
Pacing thresholds and R-wave amplitudes within the therapeutic range	12 months

Secondary Outcome Measures

Name	Time	Method
Survival Rate of Patients implanted with the Nanostim Leadless Pacemaker	2 years
Appropriate and proportional rate response during graded exercise testing	3 month follow up

Trial Locations

Locations (53)

University Hospital - University of Alabama at Birmingham (UAB); 🇺🇸 Birmingham, Alabama, United States

The Heart Center PC; 🇺🇸 Huntsville, Alabama, United States

Honor Health; 🇺🇸 Scottsdale, Arizona, United States

University of Southern California; 🇺🇸 Long Beach, California, United States

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

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

South Denver Cardiology Associates PC; 🇺🇸 Littleton, Colorado, United States

Naples Heart Rhythm Specialists PA; 🇺🇸 Naples, Florida, United States

Orlando Health; 🇺🇸 Orlando, Florida, United States

Piedmont Athens Regional Medical Center; 🇺🇸 Athens, Georgia, United States

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