INGEVITY™ Observational Trial (GENTLE)

March 26, 2021 updated by: Boston Scientific Corporation

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1184

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Graz, Austria, 8036
        • Medizinische Universitat 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
        • Hopital Prive 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 Merida
      • 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
        • Skanes universitetssjukhus
      • Stockholm, Sweden, 11219
        • St Gorans Sjukhus
  • Switzerland
      • Basel, Switzerland, 4031
        • Universitatsspital Basel
  • United Kingdom
      • Swansea, United Kingdom, SA6 6NL
        • Morriston Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Percentage of Leads Free From Complication
Time Frame: 91 calendar days post-implant
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

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
MRI Procedures Through 12 Months Post-Implant
Time Frame: 365 calendar days post implant
The percentage of subjects who underwent an MRI scan through 12 months post-implant.
365 calendar days post implant

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Boston Scientific Corporation

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 11, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 16, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 18, 2014

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 30, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 26, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • GENTLE-1013

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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