BradycardiaGENTLENCT02166606
INGEVITY™ Observational Trial
An observational study of Bradycardia, run by Boston Scientific Corporation at 60 sites in 13 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bradycardia
- What is being tested?
- ImageReady MR Conditional Pacing System Implant
- Type of treatment
- Medical device
- How many people
- 1,184 participants
- Where
- 60 sitesin 13 countries
- Study dates
- Apr 2014to Sep 2016
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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:
- GENTLE registry outcome (i.e. involve different implantable system components than required for participation in GENTLE or would affect ability to undergo MRI procedures);
- 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
Trial locations and contacts
60 sites in 13 countries.
60 sites in 13 countries
France15 sites
Clinique Rhone Durance
Avignon, 84000
Hopital Prive Saint Martin
Caen, 14000
Centre Hospitalier du Contentin
Cherbourg, 50100
Centre Hospitalier de Marne La Vallee
Jossigny, 77600
Hopital Saint Philibert
Lomme, 59462
Hopital Prive Jacques Cartier
Massy, 91300
Clinique Les Fontaines
Melun, 77000
Centre Hospitalier de Moulins
Moulins, 3000
Le Confluent - Nouvelles Cliniques Nantaises
Nantes, 44277
Hopital Regional Orleans La Source
Orléans, 45000
Groupement Hospitalier Pitie Salpetriere
Paris, 75013
Centre Hospitalier Universitaire de Poitiers
Poitiers, 86000
Centre Hospitalier de Saintonge
Saintes, 17108
Clinique Saint Gatien
Tours, 37000
Centre Hospitalier Bretagne Atlantique
Vannes, 56017
Spain8 sites
Hospital Clinic de Barcelona
Barcelona, 08036
Hospital Universitario Infanta Leonor
Madrid, 28031
Hospital Universitario Ramon y Cajal
Madrid, 28034
Hospital Puerta de Hierro
Majadahonda, 28222
Hospital de Merida
Mérida, 06800
Hospital Universitario Nuestra Senora de Candelaria
Santa Cruz de Tenerife, 38010
Hospital Clinico Universitario Valladolid
Valladolid, 47011
Hospital Virgen de la Concha
Zamora, 49022
Germany7 sites
Charite, Universitatsmedizin Berlin, Campus Benjamin Franklin, Klinik fur Kardiologie und Pulmologie
Berlin, 12203
Unfallkrankenhaus Berlin, Klinik fur Innere Medizin
Berlin, 12687
Immanuel Klinikum Bernau/Herzzentrum Brandenburg
Bernau, 16321
Universitatsklinikum Dusseldorf, Klinik fur Kardiovaskulare Chrirurgie
Düsseldorf, 40225
Cardioangiologisches Centre Bethanien
Frankfurt, 60389
Herz- und Gefäßzentrum am Krankenhaus Neu-Bethlehem
Göttingen, 37073
St. Marienkrankenhaus Siegen
Siegen, 57072
Italy7 sites
Fondazione Poliambulanza
Brescia, 25131
Ospedale Annunziata
Cosenza, 87010
Ospedale Spaziani Frosinone
Frosinone, 03100
Ospedale Guzzardi di Vittoria
Ragusa, 00932
Policlinico Casilino
Roma, 00169
Azienda ULSS 9 Treviso
Treviso, 31100
Ospedale Borgo Trento
Verona, 37126
Portugal5 sites
Hospital Professor Doutor Fernando Fonseca, EPE
Amadora, 2720-276
Centro Hospitalar do Alto Ave, EPE
Guimarães, 4835-044
CHLO, EPE, Hospital S. Francisco Xavier
Lisbon, 1449-005
CHLN, EPE Hospital de Santa Maria
Lisbon, 1649-028
Hospital dos SAMS
Lisbon, 1849-017
South Korea5 sites
Seoul National University Bundang Hospital
Gyeonggi-do, 463707
Korea University Anam Hospital
Seoul, 02841
Seoul National University Hospital
Seoul, 100744
Yonsei University Severance Hospital
Seoul, 120752
Samsung Medical Center
Seoul, 135710
Belgium4 sites
Ziekenhaus Oost Limburg
Genk, 3600
Grand Hopital De Charleroi
Gilly, 6060
Jessa Hospital
Hasselt, 3500
UCL de Mont Godinne
Yvoir, 5530
Austria2 sites
Medizinische Universitat Graz
Graz, 8036
AKh - Allgemeines Krankenhaus der Stadt Linz GmbH
Linz, 4021
Sweden2 sites
Skanes Universitetssjukhus
Lund, 22185
St Gorans Sjukhus
Stockholm, 11219
About this study
Official title: 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
- Collect clinical data on Boston Scientific's ImageReady MR Conditional Pacing Systems involving the INGEVITY lead based on observations / events
- Gather data on actual number of MRI scans performed in the patient cohort implanted with an ImageReady system including information about scanned body parts.
- 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.
- Conditions
- Bradycardia
- Being tested
- ImageReady MR Conditional Pacing System Implant
- Medical subject headings
- Bradycardia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ImageReady MR Conditional Pacing System ImplantDevice
Implant according to standard-of-care. No study-specific interventions in that registry.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: ImageReady MR Conditional Pacing System Implant |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 91 calendar days post-implant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2014 (estimated)
- Study startApr 2014
- Primary completionJun 2016
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for BradycardiaStudies of the same condition, open and under way.
- More trials run by Boston Scientific CorporationThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,184 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Scientific Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Daniel Gras, MD, Principal investigator, Nouvelles Cliniques Nantaises Cardiologie / Médecins du pôle - Unité de Soins et de Cardiologie Interventionnelle 4 rue Eric Tabarly 44277 Nantes cedex 2 FranceJohn doe, MD, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02166606
- Sponsor's protocol ID
- GENTLE-1013
- Acronym
- GENTLE
- Status last verified
- Aug 2019
- First submitted
- 11 Apr 2014
- Last updated
- 30 Mar 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- INGEVITY™ Observational Trial: Assessment of Routine Experience and Magnet Resonance Imaging (MRI) Usage With a New Lead for Bradycardia Pacing
- ClinicalTrials.gov ID
- NCT02166606
- Acronym / sponsor ID
- GENTLE / GENTLE-1013
- Conditions
- Bradycardia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,184 participants (actual)
- Lead sponsor
- Boston Scientific CorporationIndustry (pharma, biotech, devices)
- Study start
- Apr 2014 (actual)
- Primary completion
- Jun 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 18 Jun 2014 (estimated)
- Results
- Posted 20 Aug 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objectives of this registry are to
- Collect clinical data on Boston Scientific's ImageReady MR Conditional Pacing Systems involving the INGEVITY lead based on observations / events
- Gather data on actual number of MRI scans performed in the patient cohort implanted with an ImageReady system including information about scanned body parts.
- 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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pacemaker/Lead implant | – | Device: ImageReady MR Conditional Pacing System ImplantAll 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- 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:
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ImageReady MR Conditional Pacing System ImplantImplant according to standard-of-care. No study-specific interventions in that registry. | Device | Pacemaker/Lead implant |
Primary outcome
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniel Gras, MD 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 principal investigator
60 sites in 13 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bradycardia, run by Boston Scientific Corporation at 60 sites in 13 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 60 sites in France, Spain, Germany, Italy, Portugal and 8 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 Aug 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Leads Free From Complication (time frame: 91 calendar days post-implant). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2021.