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The LEADLESS Observational Study

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2016 by St. Jude Medical
Information provided by (Responsible Party):
St. Jude Medical Identifier:
First received: January 30, 2014
Last updated: May 19, 2016
Last verified: May 2016
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 Intervention
Indications for VVI(R) Pacemaker
Device: Implanted with a Nanostim leadless pacemaker system

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Nanostim Study for a Leadless Cardiac Pacemaker System

Further study details as provided by St. Jude Medical:

Primary Outcome Measures:
  • Complication free-rate [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    A complication is defined as a serious adverse device effect

Other Outcome Measures:
  • Complication free-rate [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
    A complication is defined as a serious adverse device effect

  • Complication free-rate [ Time Frame: 90 days ] [ Designated as safety issue: Yes ]
    A complication is defined as a serious adverse device effect

Estimated Enrollment: 1000
Study Start Date: December 2013
Estimated Study Completion Date: March 2022
Estimated Primary Completion Date: June 2017 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Indicated for a VVI(R) pacemaker Device: Implanted with a Nanostim leadless pacemaker system


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
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
  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 identifier: NCT02051972

Contact: Ashish Oza +1 818 493 3648
Contact: Pascale Ducloux +32 2 774 67 09

Czech Republic
Na Homolce Hospital Recruiting
Prague, Czech Republic, 150 30
Principal Investigator: Peter Neuzil, MD         
CHU Grenoble Recruiting
Grenoble, France, 38701
Principal Investigator: Pascal Defaye, MD         
Hopital La Timone Active, not recruiting
Marseille, France, 13385
CHRU Hopital de Pontchaillou Recruiting
Rennes, France, 35033
Principal Investigator: Christophe Leclercq, MD         
Kerckhoff-Klinik gGmbH Recruiting
Bad nauheim, Germany, 61231
Principal Investigator: Johannes Sperzel, MD         
Herzzentrum Dresden GmbH Universitätsklinik Recruiting
Dresden, Germany, 01307
Principal Investigator: Christopher Piorkowski, MD         
Herzzentrum Leipzig GmbH Recruiting
Leipzig, Germany, 04289
Principal Investigator: Gerhard Hindricks         
Kliniken Villingen-Schwenningen Recruiting
Villingen-Schwenningen, Germany, 78052
Principal Investigator: Werner Jung, MD         
Az. Osp. Spedali Civili di Brescia Recruiting
Brescia, Italy, 25124
Principal Investigator: Antonio Curnis, MD         
Centro Cardiologico Monzino Recruiting
Milano, Italy, 20138
Principal Investigator: Claudio Tondo, MD         
Policlinico San Donato Recruiting
San Donato Milanese, Italy, 20097
Principal Investigator: Carlo Pappone, MD         
AMC Recruiting
Amsterdam, Netherlands, 1105 AZ
Principal Investigator: Reinoud Knops, MD         
Isala Klinieken Recruiting
Zwolle, Netherlands, 8025
Principal Investigator: Peter Delnoy, MD         
Hospital Infanta Cristina Recruiting
Badajoz, Spain, 6010
Principal Investigator: Garcia Guerrero, MD         
United Kingdom
Royal Brompton Hospital Recruiting
London, United Kingdom, SW3 6NP
Principal Investigator: tom Wong, MD         
Sponsors and Collaborators
St. Jude Medical
Principal Investigator: Johannes Sperzel, MD Kerckhoff Klinick GmbH, Bad Nauheim, Germany
  More Information

Responsible Party: St. Jude Medical Identifier: NCT02051972     History of Changes
Other Study ID Numbers: LCP005 
Study First Received: January 30, 2014
Last Updated: May 19, 2016
Health Authority: Czech Republic: Ethics Committee
France: Institutional Ethical Committee
France: Agence Nationale de Sécurité du Médicament et des produits de santé
Germany: Ethics Commission
Italy: Ethics Committee
Spain: Ethics Committee
Spain: Agencia Española de Medicamentos y Productos Sanitarios
United Kingdom: Research Ethics Committee processed this record on October 27, 2016