The LEADLESS II IDE Study for the Aveir VR Leadless Pacemaker System

• ClinicalTrials.gov Identifier: NCT04559945
• Recruitment Status: Active, not recruiting
• First Posted: September 23, 2020
• Last Update Posted: June 15, 2022
• Sponsor: Abbott Medical Devices
• Information provided by (Responsible Party): Abbott Medical Devices

Tracking Information

• First Submitted Date: September 17, 2020
• First Posted Date: September 23, 2020
• Last Update Posted Date: June 15, 2022
• Actual Study Start Date: November 13, 2020
• Estimated Primary Completion Date: July 15, 2022 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: June 13, 2022)

• Complication-Free Rate [ Time Frame: 6 weeks ]
• Complication-Free Rate [ Time Frame: 12 months ]
• Pacing thresholds and R-wave amplitudes within the therapeutic range [ Time Frame: 6 Weeks ]
• Pacing thresholds and R-wave amplitudes within the therapeutic range [ Time Frame: 12 months ]

Original Primary Outcome Measures (submitted: September 17, 2020)

• complication-free rate [ Time Frame: 6 week follow up visit ]
• pacing thresholds and R-wave amplitudes within the therapeutic range [ Time Frame: 6 week follow up visit ]

Current Secondary Outcome Measures (submitted: June 13, 2022)

• Appropriate and proportional rate response during graded exercise testing [ Time Frame: 3 month follow up ]
• Survival Rate of Patients implanted with the Nanostim Leadless Pacemaker [ Time Frame: 2 years ]

Original Secondary Outcome Measures (submitted: September 17, 2020)

• Appropriate and proportional rate response during graded exercise testing [ Time Frame: 3 month follow up ]
• survival rate [ Time Frame: 2 years ]

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: The LEADLESS II IDE Study for the Aveir VR Leadless Pacemaker System
• Official Title: The LEADLESS II IDE Study (Phase II): A Safety and Effectiveness Trial for a Leadless Pacemaker System
• Brief Summary: prospective, non-randomized, multi-center, international clinical study is designed to confirm the safety and effectiveness of the Aveir LP System in a subject population indicated for a VVI(R) pacemaker.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment

Condition

• Cardiac Rhythm Disorder
• Bradycardia

Intervention

Device: Aveir VR Leadless Pacemaker System

Patients will undergo an attempted leadless pacemaker implant

Study Arms

Experimental: Aveir VR Leadless Pacemaker

VVIR pacing

Intervention: Device: Aveir VR Leadless Pacemaker System

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Active, not recruiting
• Actual Enrollment (submitted: April 15, 2022): 326
• Original Estimated Enrollment (submitted: September 17, 2020): 615
• Estimated Study Completion Date: July 15, 2022
• Estimated Primary Completion Date: July 15, 2022 (Final data collection date for primary outcome measure)

Eligibility Criteria

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 is ≥18 years of age; and
3. Subject has a 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 a signed written informed consent, approved by the IRB/EC; and
7. Subject is not pregnant and does not plan to get pregnant during the course of the study.

Exclusion Criteria:

1. Subject has known 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 (DSP);
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) device; 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 had recent cardiovascular or peripheral vascular surgery within 30 days of enrollment; or
9. Subject has an implanted leadless cardiac pacemaker or
10. Subject is implanted with an electrically-active implantable medical device with stimulation capabilities (such as neurological or cardiac stimulators).

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Canada, Czechia, France, Italy, Netherlands, Spain, United Kingdom, United States

Administrative Information

• NCT Number: NCT04559945
• Other Study ID Numbers: SJM-CIP-10226
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Device Product Not Approved or Cleared by U.S. FDA: Yes

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Abbott Medical Devices
• Original Responsible Party: Same as current
• Current Study Sponsor: Abbott Medical Devices
• Original Study Sponsor: Same as current
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Abbott Medical Devices
• Verification Date: June 2022