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The LEADLESS Observational Study

This study is currently recruiting participants.
Verified October 2017 by St. Jude Medical
Sponsor:
ClinicalTrials.gov Identifier:
NCT02051972
First Posted: January 31, 2014
Last Update Posted: October 24, 2017
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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
St. Jude Medical
  Purpose
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 ]
    A complication is defined as a serious adverse device effect


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

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


Estimated Enrollment: 1000
Actual Study Start Date: December 2013
Estimated Study Completion Date: March 2024
Primary Completion Date: March 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

  Eligibility

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.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
Criteria

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
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): NCT02051972


Contacts
Contact: Grant Kim +18184933147 GKim@sjm.com
Contact: Pascale Ducloux +32 2 774 67 09 pducloux@sjm.com

Locations
Czechia
Na Homolce Hospital Recruiting
Prague, Czechia, 150 30
Contact: Peter Neuzil, MD         
France
CHRU Albert Michallon Recruiting
Grenoble, France, 38043
Contact: Pascal Defaye, MD         
Hopital La Timone Recruiting
Marseille, France, 13385
Contact: Jean-Claude Deharo, MD         
Nouvelles cliniques Nantaises Recruiting
Nantes, France, 44270
Contact: Daniel Gras, MD         
CHRU Hopital de Pontchaillou Recruiting
Rennes, France, 35033
Contact: Christophe Leclercq, MD         
CHU Strasbourg - Hôpital de Hautepierre Recruiting
Strasbourg, France, 67200
Contact: Michel Chauvin, MD         
Germany
Kerckhoff-Klinik gGmbH Recruiting
Bad nauheim, Germany, 61231
Contact: Johannes Sperzel, MD         
Universitätsmedizin Berlin - Campus Benjamin Franklin Recruiting
Berlin, Germany, 12200
Contact: Matthias Roser, MD         
Klinikum Bielefeld gGmbH Klinikum-Mitte Recruiting
Bielefeld, Germany, 33604
Contact: Christoph Stellbrink         
Herzzentrum Dresden GmbH Universitätsklinik Recruiting
Dresden, Germany, 01307
Contact: Christopher Piorkowski, MD         
Asklepios Klinik St. Georg Recruiting
Hamburg, Germany, 20099
Contact: Karl-Heinz Kuck, MD         
Kath. Krankenhaus Marienhospital Recruiting
Herne, Germany, 44625
Contact: Hans-Joachim Trappe         
Herzzentrum Leipzig GmbH Recruiting
Leipzig, Germany, 04289
Contact: Gerhard Hindricks, MD         
Deutsches Herzzentrum München des Freistaates Bayern Recruiting
München, Germany, 80636
Contact: Christof Kolb, MD         
Kliniken Villingen-Schwenningen Recruiting
Villingen-Schwenningen, Germany, 78052
Contact: Werner Jung, MD         
Italy
Az. Osp. Spedali Civili di Brescia Recruiting
Brescia, Italy, 25124
Contact: Antonio Curnis, MD         
Ospedale Niguarda Ca'Granda Recruiting
Milano, Italy, 20132
Contact: Maurizio Lunati, MD         
Centro Cardiologico Monzino Recruiting
Milano, Italy, 20138
Contact: Claudio Tondo, MD         
Ospedale San Raffaele Recruiting
Milan, Italy, 20132
Contact: Paolo Della Bella, MD         
Policlinico San Donato Recruiting
San Donato Milanese, Italy, 20097
Contact: Carlo Pappone, MD         
Azienda Ospedaliera Bolognini Recruiting
Seriate, Italy, 24068
Contact: Maurizio Tespili         
Netherlands
AMC Recruiting
Amsterdam, Netherlands, 1105 AZ
Contact: Reinoud Knops, MD         
Isala Klinieken Recruiting
Zwolle, Netherlands, 8025
Contact: Peter Delnoy, MD         
Spain
Hospital Infanta Cristina Recruiting
Badajoz, Spain, 6080
Contact: Juan Jose Garcia Guerrero, MD         
Hospital Universitario de la Paz Recruiting
Madrid, Spain, 28046
Contact: Jorge Silvestre Garcia, MD         
Hospital Universitario de Salamanca Recruiting
Salamanca, Spain, 37007
Contact: Javier Jimenez Candil         
Hospital Universitario Donostia Recruiting
San Sebastián, Spain, 20014
Contact: Francisco Garcia Urra, MD         
Hospital do Meixoeiro Recruiting
Vigo, Spain, 36214
Contact: Enrique Garcia Campo, MD         
United Kingdom
St. Bartholomew's Hospital Recruiting
London, United Kingdom, EC1A 7BE
Contact: Richard Schilling, MD         
Royal Brompton Hospital Recruiting
London, United Kingdom, SW3 6NP
Contact: Tom Wong, MD         
Manchester Heart Center, Manchester Royal Infirmary Recruiting
Manchester, United Kingdom, M13 9WL
Contact: Amir Zaidi, MD         
John Radcliffe Hospital Recruiting
Oxford, United Kingdom, OX3 9DU
Contact: Tim Betts         
Sponsors and Collaborators
St. Jude Medical
Investigators
Principal Investigator: Johannes Sperzel, MD Kerckhoff Klinick GmbH, Bad Nauheim, Germany
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: St. Jude Medical
ClinicalTrials.gov Identifier: NCT02051972     History of Changes
Other Study ID Numbers: LCP005
First Submitted: January 30, 2014
First Posted: January 31, 2014
Last Update Posted: October 24, 2017
Last Verified: October 2017