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Trial record 1 of 1 for:    NCT04559945
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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

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.

Condition or disease Intervention/treatment Phase
Cardiac Rhythm Disorder Bradycardia Device: Aveir VR Leadless Pacemaker System Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 326 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The LEADLESS II IDE Study (Phase II): A Safety and Effectiveness Trial for a Leadless Pacemaker System
Actual Study Start Date : November 13, 2020
Estimated Primary Completion Date : July 15, 2022
Estimated Study Completion Date : July 15, 2022

Arm Intervention/treatment
Experimental: Aveir VR Leadless Pacemaker
VVIR pacing
Device: Aveir VR Leadless Pacemaker System
Patients will undergo an attempted leadless pacemaker implant




Primary Outcome Measures :
  1. Complication-Free Rate [ Time Frame: 6 weeks ]
  2. Complication-Free Rate [ Time Frame: 12 months ]
  3. Pacing thresholds and R-wave amplitudes within the therapeutic range [ Time Frame: 6 Weeks ]
  4. Pacing thresholds and R-wave amplitudes within the therapeutic range [ Time Frame: 12 months ]

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


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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 or
  10. Subject is implanted with an electrically-active implantable medical device with stimulation capabilities (such as neurological or cardiac stimulators).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04559945


Locations
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Sponsors and Collaborators
Abbott Medical Devices
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Responsible Party: Abbott Medical Devices
ClinicalTrials.gov Identifier: NCT04559945    
Other Study ID Numbers: SJM-CIP-10226
First Posted: September 23, 2020    Key Record Dates
Last Update Posted: June 15, 2022
Last Verified: June 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by Abbott Medical Devices:
Bradycardia
Pacemaker
Leadless
Additional relevant MeSH terms:
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Bradycardia
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes