Study Results
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View full resultsBasic Information
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COMPLETED
1184 participants
OBSERVATIONAL
2014-04-30
2016-09-30
Brief Summary
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1. Collect clinical data on Boston Scientific's ImageReady MR Conditional Pacing Systems involving the INGEVITY lead based on observations / events
2. Gather data on actual number of MRI scans performed in the patient cohort implanted with an ImageReady system including information about scanned body parts.
3. Collect physician feedback on lead handling with the INGEVITY lead
in a real-life, market-released standard of care environment using devices on intended purpose and which are authorized to bear the CE (Communauté Européenne) marking / are approved for use in the applicable area of participating centers. No additional invasive or other burdensome examinations are to be carried out other than the ones conducted by the centers per their general standard of care.
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Pacemaker/Lead implant
All enrolled subjects will receive an ImageReady Magnet Resonant (MR) Conditional Pacing System and the treatment assignment will be based on an "all-comers" consecutive basis.
ImageReady MR Conditional Pacing System Implant
Implant according to standard-of-care. No study-specific interventions in that registry.
Interventions
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ImageReady MR Conditional Pacing System Implant
Implant according to standard-of-care. No study-specific interventions in that registry.
Eligibility Criteria
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Inclusion Criteria
* Subject is scheduled for, or implanted with, a clinically indicated BSC ImageReady system according to current and locally applicable implant guidelines such as published by European Society of Cardiology (ESC) / American Heart Association (AHA) / American College of Cardiology (ACC) / Hearth Rhythm Society (HRS)
* Subject is geographically stable to be available for follow up at an approved registry center during the whole registry duration
* Subject is age 18 or above, or of legal age to give informed consent specific to state and national law
Exclusion Criteria
* Implanted pacing system is not ImageReady, i.e. any system components other than BSC INGEVITY MRI Conditional leads (or their market released successors), BSC INGENIO MRI family pacemaker models and their accessories (or their market released successors) intended to have MR Conditional status, including pre-existing abandoned leads of any kind still implanted and which will not be removed during the implant or re-implant procedure or plugged lead ports
* Any existing conditions per local standard of care preventing the subject from undergoing an MRI procedure including implanted active or inactive medical devices / material, not considered MR Conditional
* Subject is enrolled in any other concurrent study with the exception of local mandatory governmental registries and studies/registries that are not in conflict and do not affect the following:
1. GENTLE registry outcome (i.e. involve different implantable system components than required for participation in GENTLE or would affect ability to undergo MRI procedures);
2. Conduct of the GENTLE Registry per Good Clinical Practice (GCP)/ ISO (International Organization of Harmonization) 14155:2011/ local regulations as applicable
* Subject is a woman of childbearing potential who is, or might be, pregnant at the time of registry enrollment or plans to become pregnant during the course of the registry (based on physician's assessment)
* Estimated life expectancy of less than twelve months per physician discretion
18 Years
ALL
No
Sponsors
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Boston Scientific Corporation
INDUSTRY
Responsible Party
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Principal Investigators
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Daniel Gras, MD
Role: PRINCIPAL_INVESTIGATOR
Nouvelles Cliniques Nantaises Cardiologie / Médecins du pôle - Unité de Soins et de Cardiologie Interventionnelle 4 rue Eric Tabarly 44277 Nantes cedex 2 France
John doe, MD
Role: PRINCIPAL_INVESTIGATOR
Locations
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Medizinische Universitat Graz
Graz, , Austria
AKh - Allgemeines Krankenhaus der Stadt Linz GmbH
Linz, , Austria
Ziekenhaus Oost Limburg
Genk, , Belgium
Grand Hopital De Charleroi
Gilly, , Belgium
Jessa Hospital
Hasselt, , Belgium
UCL de Mont Godinne
Yvoir, , Belgium
Clinique Rhone Durance
Avignon, , France
Hopital Prive Saint Martin
Caen, , France
Centre Hospitalier du Contentin
Cherbourg, , France
Centre Hospitalier de Marne La Vallee
Jossigny, , France
Hopital Saint Philibert
Lomme, , France
Hopital Prive Jacques Cartier
Massy, , France
Clinique Les Fontaines
Melun, , France
Centre Hospitalier de Moulins
Moulins, , France
Le Confluent - Nouvelles Cliniques Nantaises
Nantes, , France
Hopital Regional Orleans La Source
Orléans, , France
Groupement Hospitalier Pitie Salpetriere
Paris, , France
Centre Hospitalier Universitaire de Poitiers
Poitiers, , France
Centre Hospitalier de Saintonge
Saintes, , France
Clinique Saint Gatien
Tours, , France
Centre Hospitalier Bretagne Atlantique
Vannes, , France
Charite, Universitatsmedizin Berlin, Campus Benjamin Franklin, Klinik fur Kardiologie und Pulmologie
Berlin, , Germany
Unfallkrankenhaus Berlin, Klinik fur Innere Medizin
Berlin, , Germany
Immanuel Klinikum Bernau/Herzzentrum Brandenburg
Bernau, , Germany
Universitatsklinikum Dusseldorf, Klinik fur Kardiovaskulare Chrirurgie
Düsseldorf, , Germany
Cardioangiologisches Centre Bethanien
Frankfurt, , Germany
Herz- und Gefäßzentrum am Krankenhaus Neu-Bethlehem
Göttingen, , Germany
St. Marienkrankenhaus Siegen
Siegen, , Germany
University Hospital Galway
Galway, , Ireland
Bon Secours Hospital
Tralee, , Ireland
Fondazione Poliambulanza
Brescia, , Italy
Ospedale Annunziata
Cosenza, , Italy
Ospedale Spaziani Frosinone
Frosinone, , Italy
Ospedale Guzzardi di Vittoria
Ragusa, , Italy
Policlinico Casilino
Roma, , Italy
Azienda ULSS 9 Treviso
Treviso, , Italy
Ospedale Borgo Trento
Verona, , Italy
Akershus Universitetssykehus HF
Lorenskog, , Norway
Hospital Professor Doutor Fernando Fonseca, EPE
Amadora, , Portugal
Centro Hospitalar do Alto Ave, EPE
Guimarães, , Portugal
CHLO, EPE, Hospital S. Francisco Xavier
Lisbon, , Portugal
CHLN, EPE Hospital de Santa Maria
Lisbon, , Portugal
Hospital dos SAMS
Lisbon, , Portugal
Seoul National University Bundang Hospital
Gyeonggi-do, , South Korea
Korea University Anam Hospital
Seoul, , South Korea
Seoul National University Hospital
Seoul, , South Korea
Yonsei University Severance Hospital
Seoul, , South Korea
Samsung Medical Center
Seoul, , South Korea
Hospital Clinic de Barcelona
Barcelona, , Spain
Hospital Universitario Infanta Leonor
Madrid, , Spain
Hospital Universitario Ramon y Cajal
Madrid, , Spain
Hospital Puerta de Hierro
Majadahonda, , Spain
Hospital de Merida
Mérida, , Spain
Hospital Universitario Nuestra Senora de Candelaria
Santa Cruz de Tenerife, , Spain
Hospital Clinico Universitario Valladolid
Valladolid, , Spain
Hospital Virgen de la Concha
Zamora, , Spain
Skanes Universitetssjukhus
Lund, , Sweden
St Gorans Sjukhus
Stockholm, , Sweden
Universitatsspital Basel
Basel, , Switzerland
Morriston Hospital
Swansea, , United Kingdom
Countries
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Other Identifiers
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GENTLE-1013
Identifier Type: -
Identifier Source: org_study_id
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