INGEVITY™ Observational Trial (GENTLE)

INGEVITY™ Observational Trial: Assessment of Routine Experience and Magnet Resonance Imaging (MRI) Usage With a New Lead for Bradycardia Pacing

The objectives of this registry are to

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.

Study Overview

• Status: Completed
• Conditions: Bradycardia
• Intervention / Treatment: Device: ImageReady MR Conditional Pacing System Implant

• Study Type: Observational
• Enrollment (Actual): 1184

Contacts and Locations

Study Locations

• Austria
  • Graz, Austria, 8036
    • Medizinische Universität Graz
  • Linz, Austria, 4021
    • AKh - Allgemeines Krankenhaus der Stadt Linz GmbH
• Belgium
  • Genk, Belgium, 3600
    • Ziekenhaus Oost Limburg
  • Gilly, Belgium, 6060
    • Grand Hôpital de Charleroi
  • Hasselt, Belgium, 3500
    • Jessa Hospital
  • Yvoir, Belgium, 5530
    • UCL de Mont Godinne
• France
  • Avignon, France, 84000
    • Clinique Rhône Durance
  • Caen, France, 14000
    • Hôpital Privé Saint Martin
  • Cherbourg, France, 50100
    • Centre Hospitalier du Contentin
  • Jossigny, France, 77600
    • Centre Hospitalier de Marne La Vallee
  • Lomme, France, 59462
    • Hôpital Saint Philibert
  • Massy, France, 91300
    • Hôpital Privé Jacques Cartier
  • Melun, France, 77000
    • Clinique les Fontaines
  • Moulins, France, 3000
    • Centre Hospitalier de Moulins
  • Nantes, France, 44277
    • Le Confluent - Nouvelles Cliniques Nantaises
  • Orleans, France, 45000
    • Hopital Regional Orleans La Source
  • Paris 13, France, 75013
    • Groupement Hospitalier Pitié Salpêtrière
  • Poitiers, France, 86000
    • Centre Hospitalier Universitaire de Poitiers
  • Saintes Cedex, France, 17108
    • Centre Hospitalier de Saintonge
  • Tours, France, 37000
    • Clinique Saint Gatien
  • Vannes, France, 56017
    • Centre Hospitalier Bretagne Atlantique
• Germany
  • Berlin, Germany, 12203
    • Charite, Universitatsmedizin Berlin, Campus Benjamin Franklin, Klinik fur Kardiologie und Pulmologie
  • Berlin, Germany, 12687
    • Unfallkrankenhaus Berlin, Klinik für Innere Medizin
  • Bernau, Germany, 16321
    • Immanuel Klinikum Bernau/Herzzentrum Brandenburg
  • Dusseldorf, Germany, 40225
    • Universitatsklinikum Dusseldorf, Klinik fur Kardiovaskulare Chrirurgie
  • Frankfurt, Germany, 60389
    • Cardioangiologisches Centre Bethanien
  • Goettingen, Germany, 37073
    • Herz- und Gefäßzentrum am Krankenhaus Neu-Bethlehem
  • Siegen, Germany, 57072
    • St. Marienkrankenhaus Siegen
• Ireland
  • Galway, Ireland
    • University Hospital Galway
  • Tralee, Ireland
    • Bon Secours Hospital
• Italy
  • Brescia, Italy, 25131
    • Fondazione Poliambulanza
  • Cosenza, Italy, 87010
    • Ospedale Annunziata
  • Frosinone, Italy, 03100
    • Ospedale Spaziani Frosinone
  • Ragusa, Italy, 00932
    • Ospedale Guzzardi di Vittoria
  • Roma, Italy, 00169
    • Policlinico Casilino
  • Treviso, Italy, 31100
    • Azienda ULSS 9 Treviso
  • Verona, Italy, 37126
    • Ospedale Borgo Trento
• Korea, Republic of
  • Gyeonggi-Do, Korea, Republic of, 463707
    • Seoul National University Bundang Hospital
  • Seoul, Korea, Republic of, 02841
    • Korea University Anam Hospital
  • Seoul, Korea, Republic of, 100744
    • Seoul National University Hospital
  • Seoul, Korea, Republic of, 120752
    • Yonsei University Severance Hospital
  • Seoul, Korea, Republic of, 135710
    • Samsung Medical Center
• Norway
  • Lorenskog, Norway, 1478
    • Akershus Universitetssykehus HF
• Portugal
  • Amadora, Portugal, 2720-276
    • Hospital Professor Doutor Fernando Fonseca, EPE
  • Guimaraes, Portugal, 4835-044
    • Centro Hospitalar Do Alto Ave, Epe
  • Lisbon, Portugal, 1449-005
    • CHLO, EPE, Hospital S. Francisco Xavier
  • Lisbon, Portugal, 1649-028
    • CHLN, EPE Hospital de Santa Maria
  • Lisbon, Portugal, 1849-017
    • Hospital dos SAMS
• Spain
  • Barcelona, Spain, 08036
    • Hospital Clinic De Barcelona
  • Madrid, Spain, 28034
    • Hospital Universitario Ramon y Cajal
  • Madrid, Spain, 28031
    • Hospital Universitario Infanta Leonor
  • Majadahonda, Spain, 28222
    • Hospital Puerta de Hierro
  • Merida, Spain, 06800
    • Hospital de Mérida
  • Santa Cruz de Tenerife, Spain, 38010
    • Hospital Universitario Nuestra Señora de Candelaria
  • Valladolid, Spain, 47011
    • Hospital Clinico Universitario Valladolid
  • Zamora, Spain, 49022
    • Hospital Virgen de la Concha
• Sweden
  • Lund, Sweden, 22185
    • Skånes universitetssjukhus
  • Stockholm, Sweden, 11219
    • St Gorans Sjukhus
• Switzerland
  • Basel, Switzerland, 4031
    • Universitätsspital Basel
• United Kingdom
  • Swansea, United Kingdom, SA6 6NL
    • Morriston Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

The subjects will be coming from the general patient population of the participating centers who are indicated for implantation of a BSC (Boston Scientific) ImageReady Pacing System (pulse generator [PG] & leads) and who are fulfilling all inclusion criteria and none of the exclusion criteria.

Description

Inclusion Criteria:

• Subject is willing and capable of providing informed consent and to give approval to collect / store / process personal health information by the sponsor
• 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:

• Existing contraindications for a BSC ImageReady system as mentioned in the applicable reference guides of the implanted system components including a known or suspected sensitivity to dexamethasone acetate (DXA)
• 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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Device: ImageReady MR Conditional Pacing System Implant; Implant according to standard-of-care. No study-specific interventions in that registry.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Leads Free From Complication	Lead-related complication-free rate from lead implant through the three month follow-up, based on complications that are related to the INGEVITY Lead.	91 calendar days post-implant

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
MRI Procedures Through 12 Months Post-Implant	The percentage of subjects who underwent an MRI scan through 12 months post-implant.	365 calendar days post implant

Collaborators and Investigators

• Sponsor: Boston Scientific Corporation
• Investigators: Principal Investigator: Daniel Gras, MD, Nouvelles Cliniques Nantaises Cardiologie / Médecins du pôle - Unité de Soins et de Cardiologie Interventionnelle 4 rue Eric Tabarly 44277 Nantes cedex 2 France; Principal Investigator: John doe, MD

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2014
• Primary Completion (Actual): June 1, 2016
• Study Completion (Actual): September 1, 2016

Study Registration Dates

• First Submitted: April 11, 2014
• First Submitted That Met QC Criteria: June 16, 2014
• First Posted (Estimate): June 18, 2014

Study Record Updates

• Last Update Posted (Actual): March 30, 2021
• Last Update Submitted That Met QC Criteria: March 26, 2021
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Bradycardia
• Other Study ID Numbers: GENTLE-1013