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The LEADLESS Observational Study

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ClinicalTrials.gov Identifier: NCT02051972
Recruitment Status : Active, not recruiting
First Posted : January 31, 2014
Last Update Posted : April 13, 2018
Sponsor:
Information provided by (Responsible Party):
St. Jude Medical

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

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 2024

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

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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
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

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


Locations
Czechia
Na Homolce Hospital
Prague, Czechia, 150 30
France
CHRU Albert Michallon
Grenoble, France, 38043
Hopital La Timone
Marseille, France, 13385
Nouvelles cliniques Nantaises
Nantes, France, 44270
CHRU Hopital de Pontchaillou
Rennes, France, 35033
CHU Strasbourg - Hôpital de Hautepierre
Strasbourg, France, 67200
Germany
Kerckhoff-Klinik gGmbH
Bad nauheim, Germany, 61231
Universitätsmedizin Berlin - Campus Benjamin Franklin
Berlin, Germany, 12200
Klinikum Bielefeld gGmbH Klinikum-Mitte
Bielefeld, Germany, 33604
Herzzentrum Dresden GmbH Universitätsklinik
Dresden, Germany, 01307
Asklepios Klinik St. Georg
Hamburg, Germany, 20099
Kath. Krankenhaus Marienhospital
Herne, Germany, 44625
Herzzentrum Leipzig GmbH
Leipzig, Germany, 04289
Deutsches Herzzentrum München des Freistaates Bayern
München, Germany, 80636
Kliniken Villingen-Schwenningen
Villingen-Schwenningen, Germany, 78052
Italy
Az. Osp. Spedali Civili di Brescia
Brescia, Italy, 25124
Ospedale Niguarda Ca'Granda
Milano, Italy, 20132
Centro Cardiologico Monzino
Milano, Italy, 20138
Ospedale San Raffaele
Milan, Italy, 20132
Policlinico San Donato
San Donato Milanese, Italy, 20097
Azienda Ospedaliera Bolognini
Seriate, Italy, 24068
Netherlands
AMC
Amsterdam, Netherlands, 1105 AZ
Isala Klinieken
Zwolle, Netherlands, 8025
Spain
Hospital Infanta Cristina
Badajoz, Spain, 6080
Hospital Universitario de la Paz
Madrid, Spain, 28046
Hospital Universitario de Salamanca
Salamanca, Spain, 37007
Hospital Universitario Donostia
San Sebastián, Spain, 20014
Hospital do Meixoeiro
Vigo, Spain, 36214
United Kingdom
St. Bartholomew's Hospital
London, United Kingdom, EC1A 7BE
Royal Brompton Hospital
London, United Kingdom, SW3 6NP
Manchester Heart Center, Manchester Royal Infirmary
Manchester, United Kingdom, M13 9WL
John Radcliffe Hospital
Oxford, United Kingdom, OX3 9DU
Sponsors and Collaborators
St. Jude Medical
Investigators
Principal Investigator: Johannes Sperzel, MD Kerckhoff Klinick GmbH, Bad Nauheim, Germany

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 Posted: January 31, 2014    Key Record Dates
Last Update Posted: April 13, 2018
Last Verified: April 2018