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The LEADLESS Observational Study

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. Identifier: NCT02051972
Recruitment Status : Active, not recruiting
First Posted : January 31, 2014
Last Update Posted : January 13, 2021
Information provided by (Responsible Party):
Abbott Medical Devices

Brief Summary:
The objective of the study is to confirm clinical performance and safety of the Nanostim leadless cardiac pacemaker system within its intended use and according to its instructions for use.

Condition or disease Intervention/treatment
Indications for VVI(R) Pacemaker Device: Implanted with a Nanostim leadless pacemaker system

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Study Type : Observational
Estimated Enrollment : 1000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Nanostim Study for a Leadless Cardiac Pacemaker System
Actual Study Start Date : December 2013
Actual Primary Completion Date : March 2017
Estimated Study Completion Date : March 2022

Group/Cohort Intervention/treatment
Indicated for a VVI(R) pacemaker Device: Implanted with a Nanostim leadless pacemaker system

Primary Outcome Measures :
  1. Complication free-rate [ Time Frame: 6 months ]
    A complication is defined as a serious adverse device effect

Other Outcome Measures:
  1. Complication free-rate [ Time Frame: 5 years ]
    A complication is defined as a serious adverse device effect

  2. Complication free-rate [ Time Frame: 90 days ]
    A complication is defined as a serious adverse device effect

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Subjects who are at least 18 years old and who are indicated for a VVI(R) pacemaker

Inclusion Criteria:

  • Subject must have one of the following clinical indications: Chronic atrial fibrillation with 2 or 3° AV or bifascicular bundle branch block (BBB block) ; or Normal sinus rhythm with 2º 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 is a suitable candidate based on overall health and well-being; and
  • Subject is not enrolled in another clinical investigation with a treatment arm or that could confound the results of this study; 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 EC; and
  • Subject is not pregnant and does not plan on getting pregnant during the course of the study.

Exclusion Criteria:

  • Known pacemaker syndrome, have retrograde VA conduction or suffer a drop in arterial blood pressure with the onset of ventricular pacing; or
  • Hypersensitivity to < 1 mg of dexamethasone sodium phosphate; or
  • Mechanical tricuspid valve prosthesis; or
  • Pre-existing pulmonary arterial (PA) hypertension (PA systolic pressure exceeds 40mmHg or RV systolic pressure (RVSP) as estimated by echo exceeds 40mmHg) or significant physiologically-impairing lung disease (has severe pulmonary disease producing frequent hospitalization for respiratory distress or requiring continuous home oxygen); or
  • Pre-existing ventricular pacing or defibrillation leads; or
  • Current implantation of either conventional or subcutaneous implantable cardioverter defibrillator (ICD) or cardiac resynchronization therapy (CRT); or
  • Presence of implanted vena cava filter; or
  • Evidence of thrombosis in one of the veins used for access during the procedure; or
  • Cardiovascular or peripheral vascular surgery/intervention within 30 days of enrolment; or
  • Presence of implanted leadless cardiac pacemaker

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 identifier (NCT number): NCT02051972

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Sponsors and Collaborators
Abbott Medical Devices
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Principal Investigator: Johannes Sperzel, MD Kerckhoff Klinick GmbH, Bad Nauheim, Germany
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Abbott Medical Devices Identifier: NCT02051972    
Other Study ID Numbers: LCP005
First Posted: January 31, 2014    Key Record Dates
Last Update Posted: January 13, 2021
Last Verified: January 2021