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

NCT04559945 | Active Not Recruiting DMC FDA Device

• 1 other identifier: SJM-CIP-10226
• Study Type: interventional
• Target: 326
• Locations: 8 countries
• Sites: 53

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.

Conditions

Cardiac Rhythm Disorder; Bradycardia

Keywords

Bradycardia; Pacemaker; Leadless

Outcome Measures

Primary Outcomes (4)

• Complication-Free Rate

  6 weeks

• Complication-Free Rate

  12 months

• Pacing thresholds and R-wave amplitudes within the therapeutic range

  6 Weeks

• Pacing thresholds and R-wave amplitudes within the therapeutic range

  12 months

Secondary Outcomes (2)

• Appropriate and proportional rate response during graded exercise testing

  3 month follow up

• Survival Rate of Patients implanted with the Nanostim Leadless Pacemaker

  2 years

Study Arms (1)

Aveir VR Leadless Pacemaker

EXPERIMENTAL

VVIR pacing

Device: Aveir VR Leadless Pacemaker System

Interventions

Aveir VR Leadless Pacemaker System DEVICE

Patients will undergo an attempted leadless pacemaker implant

Aveir VR Leadless Pacemaker

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Subject is ≥18 years of age; and
• Subject has a life expectancy of at least one year; and
• Subject is not enrolled in another clinical investigation; and
• Subject is willing to comply with clinical investigation procedures and agrees to return for all required follow-up visits, tests, and exams; and
• 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
• Subject is not pregnant and does not plan to get pregnant during the course of the study.

You may not qualify if:

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

Sponsors & Collaborators

• Abbott Medical Devices: lead

Study Sites (53)

University Hospital - University of Alabama at Birmingham (UAB)

Birmingham, Alabama, 35294, United States

Location

The Heart Center PC

Huntsville, Alabama, 35801, United States

Location

Honor Health

Scottsdale, Arizona, 85258, United States

Location

University of Southern California

Long Beach, California, 90803, United States

Location

Premier Cardiology Inc

Newport Beach, California, 92663, United States

Location

Huntington Memorial Hospital

Pasadena, California, 91105, United States

Location

South Denver Cardiology Associates PC

Littleton, Colorado, 80120, United States

Location

Naples Heart Rhythm Specialists PA

Naples, Florida, 34119, United States

Location

Orlando Health

Orlando, Florida, 32806, United States

Location

Piedmont Athens Regional Medical Center

Athens, Georgia, 30306, United States

Location

Redmond Regional Medical Center

Rome, Georgia, 30165, United States

Location

Kansas University Medical Center

Kansas City, Kansas, 66160, United States

Location

Kansas City Cardiac Arrhythmia Research Foundation

Overland Park, Kansas, 66211, United States

Location

St. Elizabeth Medical Center - South Unit

Edgewood, Kentucky, 41017, United States

Location

Baptist Health Lexington

Lexington, Kentucky, 40503, United States

Location

University of Kentucky

Lexington, Kentucky, 40536, United States

Location

Ochsner Medical Center

New Orleans, Louisiana, 70121, United States

Location

Lahey Clinic Medical Center

Burlington, Massachusetts, 01805, United States

Location

Ascension St. John Hospital

Detroit, Michigan, 48236, United States

Location

Sparrow Clinical Research Institute

Lansing, Michigan, 48912, United States

Location

Munson Medical Center

Traverse City, Michigan, 49684, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Mercy Hospital St. Louis

St Louis, Missouri, 63141, United States

Location

Jersey Shore University Medical Center

Ocean Township, New Jersey, 07712, United States

Location

New York Presbyterian Hospital/Cornell University

New York, New York, 10021, United States

Location

Mount Sinai Hospital

New York, New York, 10029, United States

Location

Cardiac Arrhythmia & Pacemaker Center

Roslyn, New York, 11576, United States

Location

Cone Health Medical Group HeartCare

Greensboro, North Carolina, 27401, United States

Location

University Hospitals Cleveland Medical Center

Cleveland, Ohio, 44106, United States

Location

The Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

Integris Baptist Medical Center

Oklahoma City, Oklahoma, 73112, United States

Location

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15213, United States

Location

WellSpan Health

York, Pennsylvania, 17405, United States

Location

Methodist University Hospital

Memphis, Tennessee, 38104, United States

Location

South Texas Cardiovascular Consultants

San Antonio, Texas, 78201, United States

Location

Memorial Hermann Hospital

The Woodlands, Texas, 77380, United States

Location

University of Utah Hospital

Salt Lake City, Utah, 84132, United States

Location

Inova Fairfax Hospital

Falls Church, Virginia, 22042, United States

Location

Foothills Medical Centre

Calgary, Alberta, Canada

Location

HSC, Eastern Health

St. John's, Newfoundland and Labrador, A1B 3V6, Canada

Location

Kinsgston General Hospital

Kingston, Ontario, Canada

Location

Southlake Regional Health Centre

Newmarket, Ontario, Canada

Location

Institut de Cardiologie de Montreal (Montreal Heart Inst.)

Montreal, Quebec, Canada

Location

Institut de Cardiologie de Quebec (Hospital Laval)

Québec, Quebec, Canada

Location

Na Homolce Hospital

Prague, 150 30, Czechia

Location

CHRU Albert Michallon

Grenoble, France

Location

Hopital d'adulte de la Timone

Marseille, France

Location

CHRU Hopital de Pontchaillou

Rennes, France

Location

Centro Cardiologico Monzino

Milan, Italy

Location

Amsterdam Academic Medical Centre (AMC)

Amsterdam, Netherlands

Location

Isala - ZWolle

Zwolle, Netherlands

Location

Hospital Universitario Infanta Cristina

Badajoz, 6080, Spain

Location

Royal Brompton Hospital

London, United Kingdom

Location

Related Publications (1)

• Reddy VY, Exner DV, Doshi R, Tomassoni G, Bunch TJ, Friedman P, Estes NAM, Neuzil P, de la Concha JF, Cantillon DJ; LEADLESS II Investigators. 1-Year Outcomes of a Leadless Ventricular Pacemaker: The LEADLESS II (Phase 2) Trial. JACC Clin Electrophysiol. 2023 Jul;9(7 Pt 2):1187-1189. doi: 10.1016/j.jacep.2023.01.031. Epub 2023 Mar 22. No abstract available.

  PMID: 36951813 DERIVED

MeSH Terms

Conditions

Arrhythmias, Cardiac; Bradycardia

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 17, 2020
• First Posted: September 23, 2020
• Study Start: November 13, 2020
• Primary Completion: July 18, 2022
• Study Completion: August 31, 2023
• Last Updated: December 19, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

CZ (1); NL (2); ES (1); CA (6); IT (1); GB (1); US (38); FR (3)