BradycardiaNCT02030418
The LEADLESS II IDE Study for the Nanostim Leadless Pacemaker
A study testing Leadless Pacemaker in people with Bradycardia, run by Abbott Medical Devices at 59 sites in 3 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bradycardia
- What is being tested?
- Leadless Pacemaker
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 952 participants
- Where
- 59 sitesin 3 countries
- Study dates
- Feb 2014to 15 Jul 2022
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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
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- 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
Trial locations and contacts
59 sites in 3 countries.
59 sites in 3 countries
United States50 sites
Clinical Tex Research, LLC
Amarillo, Texas, 79106
Piedmont Athens Regional Medical Center
Athens, Georgia, 30306
University Hospital - Univ. of Alabama at Birmingham
Birmingham, Alabama, 35294
Tufts Medical Center
Boston, Massachusetts, 02111
Massachusetts General Hospital
Boston, Massachusetts, 02114
Lahey Clinic Medical Center
Burlington, Massachusetts, 01805
University of Chicago
Chicago, Illinois, 60637
University Hospitals of Cleveland
Cleveland, Ohio, 44106
The Cleveland Clinic Foundation
Cleveland, Ohio, 44195
St. John Hospital and Medical Center
Detroit, Michigan, 48236
Duke University Medical Center
Durham, North Carolina, 27710
St. Elizabeth Medical Center
Edgewood, Kentucky, 41017
Fairview Southdale Hospital
Edina, Minnesota, 55435
Inova Fairfax Hospital
Falls Church, Virginia, 22031
Parkview Research Center
Fort Wayne, Indiana, 46845
Cone Health Medical Group HeartCare
Greensboro, North Carolina, 27401
Memorial Hermann Hospital
Houston, Texas, 77380
Heart Center Research, LLC.
Huntsville, Alabama, 35801
Kansas University Medical Center
Kansas City, Kansas, 66160
Scripps Health
La Jolla, California, 92037
Sparrow Research
Lansing, Michigan, 48910
Baptist Health Lexington
Lexington, Kentucky, 40503
South Denver Cardiology Associates PC
Littleton, Colorado, 80120
USC University Hospital
Los Angeles, California, 90033
Methodist University Hospital
Memphis, Tennessee, 38104
Aurora Medical Group
Milwaukee, Wisconsin, 53215
El Camino Hospital
Mountain View, California, 94040
Intermountain Heart Rhythm Specialists
Murray, Utah, 84107
Naples Community Hospital
Naples, Florida, 34102
Jersey Shore University Medical Center
Neptune City, New Jersey, 07712
Ochsner Medical Center
New Orleans, Louisiana, 70121
New York Presbyterian Hospital/Cornell University
New York, New York, 10021
Mount Sinai Hospital
New York, New York, 10029
Premier Cardiology, Inc
Newport Beach, California, 92663
Advocate Christ Medical Center
Oak Lawn, Illinois, 60453
Integris Baptist Medical Center
Oklahoma City, Oklahoma, 73112
AdventHealth Orlando
Orlando, Florida, 32803
Orlando Health
Orlando, Florida, 32806
Huntington Memorial Hospital
Pasadena, California, 91105
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213
Sequoia Hospital
Redwood City, California, 94303
Mayo Clinic
Rochester, Minnesota, 55905
Redmond Regional Medical Center
Rome, Georgia, 30165
Cardiac Arrhythmia and Pacemaker Center
Roslyn, New York, 11576
Mercy Medical Group - Cardiology
Sacramento, California, 95819
South Texas Cardiovascular Consultants
San Antonio, Texas, 78201
Mercy Hospital St. Louis
St Louis, Missouri, 63141
Munson Medical Center
Traverse, Michigan, 49684
WellSpan Health
York, Pennsylvania, 17405
Michigan Heart
Ypsilanti, Michigan, 48197
Canada6 sites
Foothills Medical Centre
Calgary, Alberta
Kinsgston General Hospital
Kingston, Ontario
Institut de Cardiologie de Montreal (Montreal Heart Inst.)
Montreal, Quebec
Southlake Regional Health Centre
Newmarket, Ontario
Institut de Cardiologie de Quebec (Hospital Laval)
Québec
Vancouver General Hospital (U of BC)
Vancouver, British Columbia
Australia3 sites
Royal Adelaide Hospital
Adelaide, South Australia
The Prince Charles Hospital
Chermside, Queensland
Princess Alexandra Hospital
Woolloongabba, Queensland
About this study
Official title: The LEADLESS II IDE Study (Phase I): Safety and Effectiveness Trial for the Nanostim Leadless Pacemaker
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.
Read the detailed description
The purpose of this study is to evaluate the safety and effectiveness of the leadless pacemaker system in treating patients with a slow heart rate or irregular heartbeats. The Nanostim leadless pacemaker provides bradycardia pacing as a pulse generator with built-in battery and electrodes, for permanent implantation in the right ventricle. As a leadless pacemaker, it does not need a connector, pacing lead, or pulse generator pocket, but it has the same operating principles as a conventional pacemaker.
- Conditions
- Bradycardia
- Being tested
- Leadless Pacemaker
- Medical subject headings
- Bradycardia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Leadless PacemakerDevice
Patients will undergo an attempted leadless pacemaker implant
| Study group | Role | What they receive |
|---|---|---|
| Leadless Pacemaker | Experimental | VVIR pacing Receives: Device: Leadless Pacemaker |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complication-Free Rate
Complication is any device-or-procedure related serious adverse event, or serious adverse device effect, including those that prevented initial implantation. Percentage of participants free from complications are reported
Measured: 6 months
Pacing Thresholds and R-wave Amplitudes Within the Therapeutic Range
Success Rate is percentage of subjects who have acceptable pacing threshold and sensing amplitudes, which are defined as pacing threshold <=2.0V at 0.4 ms pulse width and R-wave amplitude either =>5.0 mV at the 6 month visit or => value at implant.
Measured: 6 months
Secondary outcomes (1)
Appropriate and Proportional Rate Response During Graded Exercise Testing
Temperature-based rate response feature was evaluated to determine whether an appropriate and proportional rate response was achieved during maximal effort graded treadmill exercise testing protocol (CAEP). All capable subjects who have completed the 6-minute walk test (6MWT) were asked to perform a maximal effort CAEP exercise protocol to demonstrate an appropriate and proportional response of sensor-indicated rate in graded exercise tests.
Data from subjects who have completed the 6MWT and have completed at least stage 3 of the CAEP exercise protocol, or 3.6 metabolic equivalent of task (METs), were included in the analysis.
Measured: 3-6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2014 (estimated)
- Study startFeb 2014
- Primary completionJun 2015
- Study completion15 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for BradycardiaStudies of the same condition, open and under way.
- More trials run by Abbott Medical DevicesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 952 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Medical Devices
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Vivik Reddy, MD, Principal investigator, MOUNT SINAI HOSPITAL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02030418
- Sponsor's protocol ID
- DC-02374
- Status last verified
- Jun 2025
- First submitted
- 6 Jan 2014
- Last updated
- 9 Jul 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
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.
PubMed 27932427Reddy 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.
PubMed 26321198