The LEADLESS II IDE Study for the Nanostim Leadless Pacemaker
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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: NCT02030418 |
Recruitment Status :
Completed
First Posted : January 8, 2014
Last Update Posted : December 19, 2022
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Prospective, non-randomized, single-arm, international multicenter, clinical safety and effectiveness of a leadless pacemaker system in patients who are indicated for a VVIR pacemaker.
Following completion of enrollments in the IDE, patients will continue to be enrolled in the continued access phase of the study under the same protocol.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Bradycardia | Device: Leadless Pacemaker | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 526 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | The LEADLESS II IDE Study (Phase I): Safety and Effectiveness Trial for the Nanostim Leadless Pacemaker |
Actual Study Start Date : | February 2014 |
Actual Primary Completion Date : | June 2015 |
Actual Study Completion Date : | July 15, 2022 |
Arm | Intervention/treatment |
---|---|
Experimental: Leadless Pacemaker
VVIR pacing
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Device: Leadless Pacemaker
Patients will undergo an attempted leadless pacemaker implant |
- Complication-Free Rate [ Time Frame: 6 months ]
- Pacing thresholds and R-wave amplitudes within the therapeutic range [ Time Frame: 6 months ]
- appropriate and proportional rate response during graded exercise testing [ Time Frame: 3-6 months ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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 ≥18 years of age; and
- Subject has 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 written informed consent, approved by the IRB; and
- Subject is not pregnant and does not plan to get pregnant during the course of the study.
Exclusion Criteria:
- Subject has 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; or
- 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); 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 has an implanted leadless cardiac pacemaker; or
- Subject had recent cardiovascular or peripheral vascular surgery within 30 days of enrollment

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): NCT02030418

Principal Investigator: | Vivik Reddy, MD | MOUNT SINAI HOSPITAL |
Responsible Party: | Abbott Medical Devices |
ClinicalTrials.gov Identifier: | NCT02030418 |
Other Study ID Numbers: |
DC-02374 |
First Posted: | January 8, 2014 Key Record Dates |
Last Update Posted: | December 19, 2022 |
Last Verified: | December 2022 |
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 |
Bradycardia Arrhythmias, Cardiac Heart Diseases Cardiovascular Diseases Pathologic Processes |