The LEADLESS II IDE Study for the Nanostim Leadless Pacemaker

NCT02030418 | Completed Results DMC FDA Device

• 1 other identifier: DC-02374
• Study Type: interventional
• Target: 952
• Locations: 3 countries
• Sites: 59

Brief 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. 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.

Conditions

Bradycardia

Outcome Measures

Primary Outcomes (2)

• 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

  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.

  6 months

Secondary Outcomes (1)

• Appropriate and Proportional Rate Response During Graded Exercise Testing

  3-6 months

Study Arms (1)

Leadless Pacemaker

EXPERIMENTAL

VVIR pacing

Device: Leadless Pacemaker

Interventions

Leadless Pacemaker DEVICE

Patients will undergo an attempted leadless pacemaker implant

Leadless Pacemaker

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Abbott Medical Devices: lead

Study Sites (59)

University Hospital - Univ. of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

Heart Center Research, LLC.

Huntsville, Alabama, 35801, United States

Location

Scripps Health

La Jolla, California, 92037, United States

Location

USC University Hospital

Los Angeles, California, 90033, United States

Location

El Camino Hospital

Mountain View, California, 94040, United States

Location

Premier Cardiology, Inc

Newport Beach, California, 92663, United States

Location

Huntington Memorial Hospital

Pasadena, California, 91105, United States

Location

Sequoia Hospital

Redwood City, California, 94303, United States

Location

Mercy Medical Group - Cardiology

Sacramento, California, 95819, United States

Location

South Denver Cardiology Associates PC

Littleton, Colorado, 80120, United States

Location

Naples Community Hospital

Naples, Florida, 34102, United States

Location

AdventHealth Orlando

Orlando, Florida, 32803, United States

Location

Orlando Health

Orlando, Florida, 32806, United States

Location

Piedmont Athens Regional Medical Center

Athens, Georgia, 30306, United States

Location

Redmond Regional Medical Center

Rome, Georgia, 30165, United States

Location

University of Chicago

Chicago, Illinois, 60637, United States

Location

Advocate Christ Medical Center

Oak Lawn, Illinois, 60453, United States

Location

Parkview Research Center

Fort Wayne, Indiana, 46845, United States

Location

Kansas University Medical Center

Kansas City, Kansas, 66160, United States

Location

St. Elizabeth Medical Center

Edgewood, Kentucky, 41017, United States

Location

Baptist Health Lexington

Lexington, Kentucky, 40503, United States

Location

Ochsner Medical Center

New Orleans, Louisiana, 70121, United States

Location

Tufts Medical Center

Boston, Massachusetts, 02111, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Lahey Clinic Medical Center

Burlington, Massachusetts, 01805, United States

Location

St. John Hospital and Medical Center

Detroit, Michigan, 48236, United States

Location

Sparrow Research

Lansing, Michigan, 48910, United States

Location

Munson Medical Center

Traverse, Michigan, 49684, United States

Location

Michigan Heart

Ypsilanti, Michigan, 48197, United States

Location

Fairview Southdale Hospital

Edina, Minnesota, 55435, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Mercy Hospital St. Louis

St Louis, Missouri, 63141, United States

Location

Jersey Shore University Medical Center

Neptune City, New Jersey, 07712, United States

Location

New York Presbyterian Hospital/Cornell University

New York, New York, 10021, United States

Location

Mount Sinai Hospital

New York, New York, 10029, United States

Location

Cardiac Arrhythmia and Pacemaker Center

Roslyn, New York, 11576, United States

Location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Cone Health Medical Group HeartCare

Greensboro, North Carolina, 27401, United States

Location

University Hospitals of Cleveland

Cleveland, Ohio, 44106, United States

Location

The Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

Integris Baptist Medical Center

Oklahoma City, Oklahoma, 73112, United States

Location

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15213, United States

Location

WellSpan Health

York, Pennsylvania, 17405, United States

Location

Methodist University Hospital

Memphis, Tennessee, 38104, United States

Location

Clinical Tex Research, LLC

Amarillo, Texas, 79106, United States

Location

Memorial Hermann Hospital

Houston, Texas, 77380, United States

Location

South Texas Cardiovascular Consultants

San Antonio, Texas, 78201, United States

Location

Intermountain Heart Rhythm Specialists

Murray, Utah, 84107, United States

Location

Inova Fairfax Hospital

Falls Church, Virginia, 22031, United States

Location

Aurora Medical Group

Milwaukee, Wisconsin, 53215, United States

Location

The Prince Charles Hospital

Chermside, Queensland, Australia

Location

Princess Alexandra Hospital

Woolloongabba, Queensland, Australia

Location

Royal Adelaide Hospital

Adelaide, South Australia, Australia

Location

Foothills Medical Centre

Calgary, Alberta, Canada

Location

Vancouver General Hospital (U of BC)

Vancouver, British Columbia, Canada

Location

Kinsgston General Hospital

Kingston, Ontario, Canada

Location

Southlake Regional Health Centre

Newmarket, Ontario, Canada

Location

Institut de Cardiologie de Montreal (Montreal Heart Inst.)

Montreal, Quebec, Canada

Location

Institut de Cardiologie de Quebec (Hospital Laval)

Québec, Canada

Location

Related Publications (2)

• 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.

  PMID: 27932427 DERIVED

• 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.

  PMID: 26321198 DERIVED

MeSH Terms

Conditions

Bradycardia

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

Although the LEADLESS II Phase 1 study met the primary and secondary endpoints, the Nanostim LP device was not commercialized in the US and commercial sales in the EU were discontinued in 2016. The Nanostim LP device was redesigned into the Aveir VR LP device- evaluated in the LEADLESS II Phase 2 study (NCT04559945.)

Results Point of Contact

• Title: Nicole Harbert, Director Clinical Research
• Organization: Abbott Cardiac Rhythm Management

nicole.harbert@abbott.com

972-526-4841

Study Officials

• Vivik Reddy, MD

  MOUNT SINAI HOSPITAL

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 6, 2014
• First Posted: January 8, 2014
• Study Start: February 1, 2014
• Primary Completion: June 1, 2015
• Study Completion: July 15, 2022
• Last Updated: July 9, 2025
• Results First Posted: July 9, 2025

Record last verified: 2025-06

Locations

US (50); AU (3); CA (6)