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

Bradycardia Clinical Trial

Official title:

The LEADLESS II IDE Study (Phase II): A Safety and Effectiveness Trial for a Leadless Pacemaker System

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04559945
• Other study ID #: SJM-CIP-10226
• Status: Active, not recruiting
• Phase: N/A
• Start date: November 13, 2020
• Est. completion date: August 31, 2023

Study information

• Verified date: December 2022
• Source: Abbott Medical Devices
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 326
• Est. completion date: August 31, 2023
• Est. primary completion date: July 18, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Arrhythmias, Cardiac
• Bradycardia
• Cardiac Rhythm Disorder

Intervention

Device:
• Aveir VR Leadless Pacemaker System
Patients will undergo an attempted leadless pacemaker implant

Locations

Country	Name	City	State
Canada	Foothills Medical Centre	Calgary	Alberta
Canada	Kinsgston General Hospital	Kingston	Ontario
Canada	Institut de Cardiologie de Montreal (Montreal Heart Inst.)	Montreal	Quebec
Canada	Southlake Regional Health Centre	Newmarket	Ontario
Canada	Institut de Cardiologie de Quebec (Hospital Laval)	Québec	Quebec
Canada	HSC, Eastern Health	Saint John's	Newfoundland and Labrador
Czechia	Na Homolce Hospital	Praha
France	CHRU Albert Michallon	Grenoble
France	Hopital d'adulte de la Timone	Marseille
France	CHRU Hopital de Pontchaillou	Rennes
Italy	Centro Cardiologico Monzino	Milano
Netherlands	Amsterdam Academic Medical Centre (AMC)	Amsterdam
Netherlands	Isala - ZWolle	Zwolle
Spain	Hospital Universitario Infanta Cristina	Badajoz
United Kingdom	Royal Brompton Hospital	London
United States	Piedmont Athens Regional Medical Center	Athens	Georgia
United States	University Hospital - University of Alabama at Birmingham (UAB)	Birmingham	Alabama
United States	Lahey Clinic Medical Center	Burlington	Massachusetts
United States	The Cleveland Clinic Foundation	Cleveland	Ohio
United States	University Hospitals Cleveland Medical Center	Cleveland	Ohio
United States	Ascension St. John Hospital	Detroit	Michigan
United States	St. Elizabeth Medical Center - South Unit	Edgewood	Kentucky
United States	Inova Fairfax Hospital	Falls Church	Virginia
United States	Cone Health Medical Group HeartCare	Greensboro	North Carolina
United States	The Heart Center PC	Huntsville	Alabama
United States	Kansas University Medical Center	Kansas City	Kansas
United States	Sparrow Clinical Research Institute	Lansing	Michigan
United States	Baptist Health Lexington	Lexington	Kentucky
United States	University of Kentucky	Lexington	Kentucky
United States	South Denver Cardiology Associates PC	Littleton	Colorado
United States	University of Southern California	Long Beach	California
United States	Methodist University Hospital	Memphis	Tennessee
United States	Naples Heart Rhythm Specialists PA	Naples	Florida
United States	Ochsner Medical Center	New Orleans	Louisiana
United States	Mount Sinai Hospital	New York	New York
United States	New York Presbyterian Hospital/Cornell University	New York	New York
United States	Premier Cardiology Inc	Newport Beach	California
United States	Jersey Shore University Medical Center	Ocean Township	New Jersey
United States	Integris Baptist Medical Center	Oklahoma City	Oklahoma
United States	Orlando Health	Orlando	Florida
United States	Kansas City Cardiac Arrhythmia Research Foundation	Overland Park	Kansas
United States	Huntington Memorial Hospital	Pasadena	California
United States	University of Pittsburgh Medical Center	Pittsburgh	Pennsylvania
United States	Mayo Clinic	Rochester	Minnesota
United States	Redmond Regional Medical Center	Rome	Georgia
United States	Cardiac Arrhythmia & Pacemaker Center	Roslyn	New York
United States	Mercy Hospital St. Louis	Saint Louis	Missouri
United States	University of Utah Hospital	Salt Lake City	Utah
United States	South Texas Cardiovascular Consultants	San Antonio	Texas
United States	Honor Health	Scottsdale	Arizona
United States	Memorial Hermann Hospital	The Woodlands	Texas
United States	Munson Medical Center	Traverse City	Michigan
United States	WellSpan Health	York	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Abbott Medical Devices

Countries where clinical trial is conducted

United States,  Canada,  Czechia,  France,  Italy,  Netherlands,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Complication-Free Rate		6 weeks
Primary	Complication-Free Rate		12 months
Primary	Pacing thresholds and R-wave amplitudes within the therapeutic range		6 Weeks
Primary	Pacing thresholds and R-wave amplitudes within the therapeutic range		12 months
Secondary	Appropriate and proportional rate response during graded exercise testing		3 month follow up
Secondary	Survival Rate of Patients implanted with the Nanostim Leadless Pacemaker		2 years