The LEADLESS II IDE Study for the Nanostim Leadless Pacemaker
NCT ID: NCT02030418
Last Updated: 2025-07-09
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
952 participants
INTERVENTIONAL
2014-02-28
2022-07-15
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
The LEADLESS II IDE Study for the Aveir VR Leadless Pacemaker System
NCT04559945
The LEADLESS Observational Study
NCT02051972
Efficacy and Safety of Leadless Pacemakers Versus Left Bundle Area Pacing - A Preliminary Exploration
NCT06690333
AVEIR™ Leadless Pacemaker (LP) United Kingdom (UK) Registry
NCT06854484
Aveir DR i2i Study
NCT05252702
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Leadless Pacemaker
VVIR pacing
Leadless Pacemaker
Patients will undergo an attempted leadless pacemaker implant
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Leadless Pacemaker
Patients will undergo an attempted leadless pacemaker implant
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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 ≥18 years of age; and
3. Subject has 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 written informed consent, approved by the IRB; and
7. Subject is not pregnant and does not plan to get pregnant during the course of the study.
Exclusion Criteria
2. Subject is allergic or hypersensitive to \<1 mg of dexamethasone sodium phosphate; or
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); 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 has an implanted leadless cardiac pacemaker; or
9. Subject had recent cardiovascular or peripheral vascular surgery within 30 days of enrollment
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Abbott Medical Devices
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Vivik Reddy, MD
Role: PRINCIPAL_INVESTIGATOR
MOUNT SINAI HOSPITAL
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University Hospital - Univ. of Alabama at Birmingham
Birmingham, Alabama, United States
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
St. John Hospital and Medical Center
Detroit, Michigan, United States
Sparrow Research
Lansing, Michigan, United States
Munson Medical Center
Traverse, Michigan, United States
Michigan Heart
Ypsilanti, Michigan, United States
Fairview Southdale Hospital
Edina, Minnesota, United States
Mayo Clinic
Rochester, Minnesota, United States
Mercy Hospital St. Louis
St Louis, Missouri, United States
Jersey Shore University Medical Center
Neptune City, New Jersey, United States
New York Presbyterian Hospital/Cornell University
New York, New York, United States
Mount Sinai Hospital
New York, New York, United States
Cardiac Arrhythmia and Pacemaker Center
Roslyn, New York, United States
Duke University Medical Center
Durham, North Carolina, United States
Cone Health Medical Group HeartCare
Greensboro, North Carolina, United States
University Hospitals of Cleveland
Cleveland, Ohio, United States
The Cleveland Clinic Foundation
Cleveland, Ohio, United States
Integris Baptist Medical Center
Oklahoma City, Oklahoma, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States
WellSpan Health
York, Pennsylvania, United States
Methodist University Hospital
Memphis, Tennessee, United States
Clinical Tex Research, LLC
Amarillo, Texas, United States
Memorial Hermann Hospital
Houston, Texas, United States
South Texas Cardiovascular Consultants
San Antonio, Texas, United States
Intermountain Heart Rhythm Specialists
Murray, Utah, United States
Inova Fairfax Hospital
Falls Church, Virginia, United States
Aurora Medical Group
Milwaukee, Wisconsin, United States
The Prince Charles Hospital
Chermside, Queensland, Australia
Princess Alexandra Hospital
Woolloongabba, Queensland, Australia
Royal Adelaide Hospital
Adelaide, South Australia, Australia
Foothills Medical Centre
Calgary, Alberta, Canada
Vancouver General Hospital (U of BC)
Vancouver, British Columbia, Canada
Kinsgston General Hospital
Kingston, Ontario, Canada
Southlake Regional Health Centre
Newmarket, Ontario, Canada
Institut de Cardiologie de Montreal (Montreal Heart Inst.)
Montreal, Quebec, Canada
Institut de Cardiologie de Quebec (Hospital Laval)
Québec, , Canada
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Reddy VY, Miller MA, Knops RE, Neuzil P, Defaye P, Jung W, Doshi R, Castellani M, Strickberger A, Mead RH, Doppalapudi H, Lakkireddy D, Bennett M, Sperzel J. Retrieval of the Leadless Cardiac Pacemaker: A Multicenter Experience. Circ Arrhythm Electrophysiol. 2016 Dec;9(12):e004626. doi: 10.1161/CIRCEP.116.004626.
Reddy VY, Exner DV, Cantillon DJ, Doshi R, Bunch TJ, Tomassoni GF, Friedman PA, Estes NA 3rd, Ip J, Niazi I, Plunkitt K, Banker R, Porterfield J, Ip JE, Dukkipati SR; LEADLESS II Study Investigators. Percutaneous Implantation of an Entirely Intracardiac Leadless Pacemaker. N Engl J Med. 2015 Sep 17;373(12):1125-35. doi: 10.1056/NEJMoa1507192. Epub 2015 Aug 30.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
DC-02374
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.