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The LEADLESS II IDE Study (Phase I)

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ClinicalTrials.gov Identifier: NCT02030418
Recruitment Status : Active, not recruiting
First Posted : January 8, 2014
Last Update Posted : June 24, 2021
Sponsor:
Information provided by (Responsible Party):
Abbott Medical Devices

Study Description
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Brief Summary:

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

Detailed Description:
The purpose of this study is to evaluate the safety and effectiveness of the leadless pacemaker system in treating patients with a slow heart rate or irregular heartbeats. The Nanostim leadless pacemaker provides bradycardia pacing as a pulse generator with built-in battery and electrodes, for permanent implantation in the right ventricle. As a leadless pacemaker, it does not need a connector, pacing lead, or pulse generator pocket, but it has the same operating principles as a conventional pacemaker.
Study Design
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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
Estimated Study Completion Date : December 31, 2021
Arms and Interventions
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Arm Intervention/treatment
Experimental: Leadless Pacemaker
VVIR pacing
 Device: Leadless Pacemaker
Patients will undergo an attempted leadless pacemaker implant


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

Secondary Outcome Measures :
  1. appropriate and proportional rate response during graded exercise testing [ Time Frame: 3-6 months ]

Eligibility Criteria
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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 ≥18 years of age; and
  3. Subject has 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 written informed consent, approved by the IRB; and
  7. Subject is not pregnant and does not plan to get pregnant during the course of the study.

Exclusion Criteria:

  1. Subject has 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; or
  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); 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 has an implanted leadless cardiac pacemaker; or
  9. Subject had recent cardiovascular or peripheral vascular surgery within 30 days of enrollment
Contacts and Locations
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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): NCT02030418


Locations
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Sponsors and Collaborators
Abbott Medical Devices
Investigators
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Principal Investigator: Vivik Reddy, MD MOUNT SINAI HOSPITAL
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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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: June 24, 2021
Last Verified: June 2021

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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
Additional relevant MeSH terms:
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Bradycardia
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes