The LEADLESS II IDE Study for the Nanostim Leadless Pacemaker

Not Applicable

Completed

• Conditions: Bradycardia

• Registration Number: NCT02030418
• Lead Sponsor: Abbott Medical Devices

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.

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.

Study Timeline

• Study First Submitted: 2014-01-06
• Study First Submitted QC: 2014-01-06
• Study First Posted: 2014-01-08
• Study Start: 2014-02-01
• Primary Completion: 2015-06
• Study Completion: 2022-07-15
• Results First Submitted: 2025-04-30
• Status Verified: 2025-06
• Results First Submitted QC: 2025-06-20
• Last Update Submitted: 2025-06-20
• Results First Posted: 2025-07-09
• Last Update Posted: 2025-07-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 952

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Complication-Free Rate	6 months	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
Pacing Thresholds and R-wave Amplitudes Within the Therapeutic Range	6 months	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.

Secondary Outcome Measures

Name	Time	Method
Appropriate and Proportional Rate Response During Graded Exercise Testing	3-6 months	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.

Trial Locations

Locations (59)

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

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