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History of Changes for Study: NCT04559945
The LEADLESS II IDE Study (Phase II): A Safety and Effectiveness Trial for a Leadless Pacemaker System
Latest version (submitted June 13, 2022) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 September 17, 2020 None (earliest Version on record)
2 December 11, 2020 Recruitment Status, Study Status, Contacts/Locations and Oversight
3 March 19, 2021 Study Status and Contacts/Locations
4 April 27, 2021 Study Status and Contacts/Locations
5 May 7, 2021 Contacts/Locations and Study Status
6 June 21, 2021 Study Status and Contacts/Locations
7 November 15, 2021 Contacts/Locations, Study Status and Eligibility
8 April 15, 2022 Recruitment Status, Study Status, Contacts/Locations and Study Design
9 June 13, 2022 Outcome Measures, Arms and Interventions, Study Status, Study Identification and Conditions
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Study NCT04559945
Submitted Date:  September 17, 2020 (v1)

Open or close this module Study Identification
Unique Protocol ID: SJM-CIP-10226
Brief Title: The LEADLESS II IDE Study (Phase II): A Safety and Effectiveness Trial for a Leadless Pacemaker System
Official Title: The LEADLESS II IDE Study (Phase II)
Secondary IDs:
Open or close this module Study Status
Record Verification: September 2020
Overall Status: Not yet recruiting
Study Start: December 2020
Primary Completion: April 2021 [Anticipated]
Study Completion: March 2022 [Anticipated]
First Submitted: September 17, 2020
First Submitted that
Met QC Criteria:
September 17, 2020
First Posted: September 23, 2020 [Actual]
Last Update Submitted that
Met QC Criteria:
September 17, 2020
Last Update Posted: September 23, 2020 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: Abbott Medical Devices
Responsible Party: Sponsor
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug: No
U.S. FDA-regulated Device: Yes
Unapproved/Uncleared Device: Yes
Pediatric Postmarket Surveillance:
Data Monitoring: Yes
Open or close this module Study Description
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:
Open or close this module Conditions
Conditions:
Keywords:
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Not Applicable
Interventional Study Model: Single Group Assignment
Number of Arms: 1
Masking: None (Open Label)
Allocation: N/A
Enrollment: 615 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Experimental: Aveir Leadless Pacemaker
VVIR pacing
Device: Aveir Leadless Pacemaker System
Patients will undergo an attempted leadless pacemaker implant
Open or close this module Outcome Measures
Primary Outcome Measures:
1. complication-free rate
[ Time Frame: 6 week follow up visit ]

2. pacing thresholds and R-wave amplitudes within the therapeutic range
[ Time Frame: 6 week follow up visit ]

Secondary Outcome Measures:
1. Appropriate and proportional rate response during graded exercise testing
[ Time Frame: 3 month follow up ]

2. survival rate
[ Time Frame: 2 years ]

Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age:
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
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
Open or close this module Contacts/Locations
Central Contact Person: Sharon Rabine
Telephone: 2245549717
Email: sharon.rabine@abbott.com
Locations:
Open or close this module IPDSharing
Plan to Share IPD: No
Open or close this module References
Citations:
Links:
Available IPD/Information:

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