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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04559945
Recruitment Status : Active, not recruiting
First Posted : September 23, 2020
Last Update Posted : June 15, 2022
Sponsor:
Information provided by (Responsible Party):
Abbott Medical Devices

Tracking Information
First Submitted Date  ICMJE September 17, 2020
First Posted Date  ICMJE September 23, 2020
Last Update Posted Date June 15, 2022
Actual Study Start Date  ICMJE November 13, 2020
Estimated Primary Completion Date July 15, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (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  ICMJE
 (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 ]
Change History
Current Secondary Outcome Measures  ICMJE
 (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  ICMJE
 (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  ICMJE The LEADLESS II IDE Study for the Aveir VR Leadless Pacemaker System
Official Title  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Cardiac Rhythm Disorder
  • Bradycardia
Intervention  ICMJE Device: Aveir VR Leadless Pacemaker System
Patients will undergo an attempted leadless pacemaker implant
Study Arms  ICMJE Experimental: Aveir VR Leadless Pacemaker
VVIR pacing
Intervention: Device: Aveir VR Leadless Pacemaker System
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: April 15, 2022)
326
Original Estimated Enrollment  ICMJE
 (submitted: September 17, 2020)
615
Estimated Study Completion Date  ICMJE July 15, 2022
Estimated Primary Completion Date July 15, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada,   Czechia,   France,   Italy,   Netherlands,   Spain,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04559945
Other Study ID Numbers  ICMJE 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  ICMJE
Plan to Share IPD: No
Current Responsible Party Abbott Medical Devices
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Abbott Medical Devices
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Abbott Medical Devices
Verification Date June 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP