The LEADLESS II IDE

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by St. Jude Medical
Sponsor:
Information provided by (Responsible Party):
St. Jude Medical
ClinicalTrials.gov Identifier:
NCT02030418
First received: January 6, 2014
Last updated: April 1, 2014
Last verified: April 2014
  Purpose

Prospective, non-randomized, single-arm, international multicenter, clinical safety and effectiveness investigation.


Condition Intervention Phase
Subjects Who Are Indicated for a VVI(R) Pacemaker.
Device: Leadless Pacemaker
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Safety and Effectiveness Trial for the Nanostim Leadless Pacemaker

Further study details as provided by St. Jude Medical:

Primary Outcome Measures:
  • Complication-Free Rate [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • Pacing thresholds and R-wave amplitudes within the therapeutic range [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • appropriate and proportional rate response during graded exercise testing [ Time Frame: 3-6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 667
Study Start Date: February 2014
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Leadless Pacemaker Device: Leadless Pacemaker

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Subject must have one of the clinical indications 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 pulmonary arterial (PA) hypertension (PA systolic pressure exceeds 40 mmHg or RV systolic pressure (RVSP) as estimated by echo exceeds 40 mmHg), or significant physiologically-impairing lung disease; or
  5. Subject has a pre-existing pacing or defibrillation leads; or
  6. Subject has current implantation of either conventional or subcutaneous implantable cardioverter defibrillator (ICD) or cardiac resynchronization therapy (CRT); or
  7. Subject has an implanted vena cava filter; or
  8. Subject has evidence of thrombosis in one of the veins used for access during the procedure; or
  9. Subject has an implanted leadless cardiac pacemaker.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02030418

Locations
United States, New York
Mount Sinai Hospital Recruiting
New York, New York, United States, 10029
Contact: Vivek Reddy, MD    212-741-7272    vivek.reddy@mountsinai.org   
Contact: Srinivas Dukkipati, MD    (212) 741-7272    srinivas.dukkipati@mountsinai.org   
Sponsors and Collaborators
St. Jude Medical
  More Information

No publications provided

Responsible Party: St. Jude Medical
ClinicalTrials.gov Identifier: NCT02030418     History of Changes
Other Study ID Numbers: DC-02374
Study First Received: January 6, 2014
Last Updated: April 1, 2014
Health Authority: United States: Food and Drug Administration

ClinicalTrials.gov processed this record on September 18, 2014