Bradycardia Clinical Trial
Official title:
The LEADLESS II IDE Study (Phase II): A Safety and Effectiveness Trial for a Leadless Pacemaker System
Verified date | December 2022 |
Source | Abbott Medical Devices |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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). |
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 |
Lead Sponsor | Collaborator |
---|---|
Abbott Medical Devices |
United States, Canada, Czechia, France, Italy, Netherlands, Spain, United Kingdom,
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 |
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