The LEADLESS II IDE Study for the Nanostim Leadless Pacemaker

Bradycardia Clinical Trial

Official title:

The LEADLESS II IDE Study (Phase I): Safety and Effectiveness Trial for the Nanostim Leadless Pacemaker

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02030418
• Other study ID #: DC-02374
• Status: Completed
• Phase: N/A
• Start date: February 2014
• Est. completion date: July 15, 2022

Study information

• Verified date: December 2022
• Source: Abbott Medical Devices
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 526
• Est. completion date: July 15, 2022
• Est. primary completion date: June 2015
• 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 =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:

1. Subject has 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; 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

Related Conditions & MeSH terms

• Bradycardia

Intervention

Device:
• Leadless Pacemaker
Patients will undergo an attempted leadless pacemaker implant

Locations

Country	Name	City	State
Australia	Royal Adelaide Hospital	Adelaide	South Australia
Australia	The Prince Charles Hospital	Chermside	Queensland
Australia	Princess Alexandra Hospital	Woolloongabba	Queensland
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)	Quebec
Canada	Vancouver General Hospital (U of BC)	Vancouver	British Columbia
United States	Clinical Tex Research, LLC	Amarillo	Texas
United States	Piedmont Athens Regional Medical Center	Athens	Georgia
United States	University Hospital - Univ. of Alabama at Birmingham	Birmingham	Alabama
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	Tufts Medical Center	Boston	Massachusetts
United States	Lahey Clinic Medical Center	Burlington	Massachusetts
United States	University of Chicago	Chicago	Illinois
United States	The Cleveland Clinic Foundation	Cleveland	Ohio
United States	University Hospitals of Cleveland	Cleveland	Ohio
United States	St. John Hospital and Medical Center	Detroit	Michigan
United States	Duke University Medical Center	Durham	North Carolina
United States	St. Elizabeth Medical Center	Edgewood	Kentucky
United States	Fairview Southdale Hospital	Edina	Minnesota
United States	Inova Fairfax Hospital	Falls Church	Virginia
United States	Parkview Research Center	Fort Wayne	Indiana
United States	Cone Health Medical Group HeartCare	Greensboro	North Carolina
United States	Memorial Hermann Hospital	Houston	Texas
United States	Heart Center Research, LLC.	Huntsville	Alabama
United States	Kansas University Medical Center	Kansas City	Kansas
United States	Scripps Health	La Jolla	California
United States	Sparrow Research	Lansing	Michigan
United States	Baptist Health Lexington	Lexington	Kentucky
United States	South Denver Cardiology Associates PC	Littleton	Colorado
United States	USC University Hospital	Los Angeles	California
United States	Methodist University Hospital	Memphis	Tennessee
United States	Aurora Medical Group	Milwaukee	Wisconsin
United States	El Camino Hospital	Mountain View	California
United States	Intermountain Heart Rhythm Specialists	Murray	Utah
United States	Naples Community Hospital	Naples	Florida
United States	Jersey Shore University Medical Center	Neptune	New Jersey
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	Advocate Christ Medical Center	Oak Lawn	Illinois
United States	Integris Baptist Medical Center	Oklahoma City	Oklahoma
United States	AdventHealth Orlando	Orlando	Florida
United States	Orlando Health	Orlando	Florida
United States	Huntington Memorial Hospital	Pasadena	California
United States	University of Pittsburgh Medical Center	Pittsburgh	Pennsylvania
United States	Sequoia Hospital	Redwood City	California
United States	Mayo Clinic	Rochester	Minnesota
United States	Redmond Regional Medical Center	Rome	Georgia
United States	Cardiac Arrhythmia and Pacemaker Center	Roslyn	New York
United States	Mercy Medical Group - Cardiology	Sacramento	California
United States	Mercy Hospital St. Louis	Saint Louis	Missouri
United States	South Texas Cardiovascular Consultants	San Antonio	Texas
United States	Munson Medical Center	Traverse	Michigan
United States	WellSpan Health	York	Pennsylvania
United States	Michigan Heart	Ypsilanti	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Abbott Medical Devices

Countries where clinical trial is conducted

United States,  Australia,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Complication-Free Rate		6 months
Primary	Pacing thresholds and R-wave amplitudes within the therapeutic range		6 months
Secondary	appropriate and proportional rate response during graded exercise testing		3-6 months