Clinical trial NCT04559945: The LEADLESS II IDE Study for the Aveir VR Leadless Pacemaker System
Official title: The LEADLESS II IDE Study (Phase II): A Safety and Effectiveness Trial for a Leadless Pacemaker System
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Cardiac Rhythm Disorder
Bradycardia
Keywords: Bradycardia
Pacemaker
Leadless
Lead sponsor: Abbott Medical Devices
Sponsor class: INDUSTRY
First posted: 2020-09-23
Enrollment: 326
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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).

Primary outcomes:
measure: Complication-Free Rate
timeFrame: 6 weeks
measure: Complication-Free Rate
timeFrame: 12 months
measure: Pacing thresholds and R-wave amplitudes within the therapeutic range
timeFrame: 6 Weeks
measure: Pacing thresholds and R-wave amplitudes within the therapeutic range
timeFrame: 12 months
Secondary outcomes:
measure: Appropriate and proportional rate response during graded exercise testing
timeFrame: 3 month follow up
measure: Survival Rate of Patients implanted with the Nanostim Leadless Pacemaker
timeFrame: 2 years
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University Hospital - University of Alabama at Birmingham (UAB)
state: Alabama
city: Huntsville
country: United States
facility: The Heart Center PC
state: Alabama
city: Scottsdale
country: United States
facility: Honor Health
state: Arizona
city: Long Beach
country: United States
facility: University of Southern California
state: California
city: Newport Beach
country: United States
facility: Premier Cardiology Inc
state: California
city: Pasadena
country: United States
facility: Huntington Memorial Hospital
state: California
city: Littleton
country: United States
facility: South Denver Cardiology Associates PC
state: Colorado
city: Naples
country: United States
facility: Naples Heart Rhythm Specialists PA
state: Florida
city: Orlando
country: United States
facility: Orlando Health
state: Florida
city: Athens
country: United States
facility: Piedmont Athens Regional Medical Center
state: Georgia
city: Rome
country: United States
facility: Redmond Regional Medical Center
state: Georgia
city: Kansas City
country: United States
facility: Kansas University Medical Center
state: Kansas
city: Overland Park
country: United States
facility: Kansas City Cardiac Arrhythmia Research Foundation
state: Kansas
city: Edgewood
country: United States
facility: St. Elizabeth Medical Center - South Unit
state: Kentucky
city: Lexington
country: United States
facility: Baptist Health Lexington
state: Kentucky
city: Lexington
country: United States
facility: University of Kentucky
state: Kentucky
city: New Orleans
country: United States
facility: Ochsner Medical Center
state: Louisiana
city: Burlington
country: United States
facility: Lahey Clinic Medical Center
state: Massachusetts
city: Detroit
country: United States
facility: Ascension St. John Hospital
state: Michigan
city: Lansing
country: United States
facility: Sparrow Clinical Research Institute
state: Michigan
city: Traverse City
country: United States
facility: Munson Medical Center
state: Michigan
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Saint Louis
country: United States
facility: Mercy Hospital St. Louis
state: Missouri
city: Ocean Township
country: United States
facility: Jersey Shore University Medical Center
state: New Jersey
city: New York
country: United States
facility: New York Presbyterian Hospital/Cornell University
state: New York
city: New York
country: United States
facility: Mount Sinai Hospital
state: New York
city: Roslyn
country: United States
facility: Cardiac Arrhythmia & Pacemaker Center
state: New York
city: Greensboro
country: United States
facility: Cone Health Medical Group HeartCare
state: North Carolina
city: Cleveland
country: United States
facility: University Hospitals Cleveland Medical Center
state: Ohio
city: Cleveland
country: United States
facility: The Cleveland Clinic Foundation
state: Ohio
city: Oklahoma City
country: United States
facility: Integris Baptist Medical Center
state: Oklahoma
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center
state: Pennsylvania
city: York
country: United States
facility: WellSpan Health
state: Pennsylvania
city: Memphis
country: United States
facility: Methodist University Hospital
state: Tennessee
city: San Antonio
country: United States
facility: South Texas Cardiovascular Consultants
state: Texas
city: The Woodlands
country: United States
facility: Memorial Hermann Hospital
state: Texas
city: Salt Lake City
country: United States
facility: University of Utah Hospital
state: Utah
city: Falls Church
country: United States
facility: Inova Fairfax Hospital
state: Virginia
city: Calgary
country: Canada
facility: Foothills Medical Centre
state: Alberta
city: Saint John's
country: Canada
facility: HSC, Eastern Health
state: Newfoundland and Labrador
city: Kingston
country: Canada
facility: Kinsgston General Hospital
state: Ontario
city: Newmarket
country: Canada
facility: Southlake Regional Health Centre
state: Ontario
city: Montreal
country: Canada
facility: Institut de Cardiologie de Montreal (Montreal Heart Inst.)
state: Quebec
city: Québec
country: Canada
facility: Institut de Cardiologie de Quebec (Hospital Laval)
state: Quebec
city: Praha
country: Czechia
facility: Na Homolce Hospital
city: Grenoble
country: France
facility: CHRU Albert Michallon
city: Marseille
country: France
facility: Hopital d'adulte de la Timone
city: Rennes
country: France
facility: CHRU Hopital de Pontchaillou
city: Milano
country: Italy
facility: Centro Cardiologico Monzino
city: Amsterdam
country: Netherlands
facility: Amsterdam Academic Medical Centre (AMC)
city: Zwolle
country: Netherlands
facility: Isala - ZWolle
city: Badajoz
country: Spain
facility: Hospital Universitario Infanta Cristina
city: London
country: United Kingdom
facility: Royal Brompton Hospital
Study officials:
References: