The LEADLESS II IDE Study for the Nanostim Leadless Pacemaker

Completed · Not applicable

Conditions studied: Bradycardia

In brief

Prospective, non-randomized, single-arm, international multicenter, clinical safety and effectiveness of a leadless pacemaker system in patients who are indicated for a VVIR pacemaker. Following completion of enrollments in the IDE, patients will continue to be enrolled in the continued access phase of the study under the same protocol.

Key facts

Study ID

NCT02030418

Run by

Abbott Medical Devices

People needed

952

Starts

2014-02-01

Expected to finish

2022-07-15

Last updated by the study team

2025-07-09

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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 ≥18 years of age; and
• Subject has 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 written informed consent, approved by the IRB; 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 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; or
• 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); 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 has an implanted leadless cardiac pacemaker; or
• Subject had recent cardiovascular or peripheral vascular surgery within 30 days of enrollment

Where it is running

• Heart Center Research, LLC. — Huntsville, Alabama, United States
• Scripps Health — La Jolla, California, United States
• USC University Hospital — Los Angeles, California, United States
• El Camino Hospital — Mountain View, California, United States
• Premier Cardiology, Inc — Newport Beach, California, United States
• Huntington Memorial Hospital — Pasadena, California, United States
• Sequoia Hospital — Redwood City, California, United States
• Mercy Medical Group - Cardiology — Sacramento, California, United States
• South Denver Cardiology Associates PC — Littleton, Colorado, United States
• Naples Community Hospital — Naples, Florida, United States
• AdventHealth Orlando — Orlando, Florida, United States
• Orlando Health — Orlando, Florida, United States
• Piedmont Athens Regional Medical Center — Athens, Georgia, United States
• Redmond Regional Medical Center — Rome, Georgia, United States
• University of Chicago — Chicago, Illinois, United States
• Advocate Christ Medical Center — Oak Lawn, Illinois, United States
• Parkview Research Center — Fort Wayne, Indiana, United States
• Kansas University Medical Center — Kansas City, Kansas, United States
• St. Elizabeth Medical Center — Edgewood, Kentucky, United States
• Baptist Health Lexington — Lexington, Kentucky, United States
• Ochsner Medical Center — New Orleans, Louisiana, United States
• Tufts Medical Center — Boston, Massachusetts, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• Lahey Clinic Medical Center — Burlington, Massachusetts, United States
• University Hospital - Univ. of Alabama at Birmingham — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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