Trial record 1 of 1 for:
NCT04559945
The LEADLESS II IDE Study (Phase II): A Safety and Effectiveness Trial for a Leadless Pacemaker System
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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 |
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Recruitment Status :
Active, not recruiting
First Posted : September 23, 2020
Last Update Posted : April 19, 2022
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Sponsor:
Abbott Medical Devices
Information provided by (Responsible Party):
Abbott Medical Devices
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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.
| Intervention/treatment | Phase |
|---|---|
| Device: Aveir Leadless Pacemaker System | Not Applicable |
| 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) |
| Actual Study Start Date : | November 13, 2020 |
| Estimated Primary Completion Date : | July 15, 2022 |
| Estimated Study Completion Date : | July 15, 2022 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Aveir Leadless Pacemaker
VVIR pacing
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Device: Aveir Leadless Pacemaker System
Patients will undergo an attempted leadless pacemaker implant |
Primary Outcome Measures :
- 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 ]
Secondary Outcome Measures :
- Appropriate and proportional rate response during graded exercise testing [ Time Frame: 3 month follow up ]
- survival rate [ 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:
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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
- Subject is ≥18 years of age; and
- Subject has a life expectancy of at least one year; and
- Subject is not enrolled in another clinical investigation; and
- Subject is willing to comply with clinical investigation procedures and agrees to return for all required follow-up visits, tests, and exams; and
- 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
- Subject is not pregnant and does not plan to get pregnant during the course of the study.
Exclusion Criteria:
- Subject has known pacemaker syndrome, has retrograde VA conduction, or suffers a drop in arterial blood pressure with the onset of ventricular pacing; or
- Subject is allergic or hypersensitive to < 1 mg of dexamethasone sodium phosphate (DSP);
- Subject has a mechanical tricuspid valve prosthesis; or
- Subject has a pre-existing endocardial pacing or defibrillation leads; or
- Subject has current implantation of either conventional or subcutaneous implantable cardioverter defibrillator (ICD) or cardiac resynchronization therapy (CRT) device; or
- Subject has an implanted vena cava filter; or
- Subject has evidence of thrombosis in one of the veins used for access during the procedure; or
- Subject had recent cardiovascular or peripheral vascular surgery within 30 days of enrollment; or
- Subject has an implanted leadless cardiac pacemaker or
- 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
| 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: | April 19, 2022 |
| Last Verified: | April 2022 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| 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 |