INGEVITY™ Observational Trial

Bradycardia Clinical Trial

— GENTLE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02166606
• Other study ID #: GENTLE-1013
• Status: Completed
• Start date: April 2014
• Est. completion date: September 2016

Study information

• Verified date: August 2019
• Source: Boston Scientific Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1184
• Est. completion date: September 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Bradycardia

Intervention

Device:
• ImageReady MR Conditional Pacing System Implant
Implant according to standard-of-care. No study-specific interventions in that registry.

Locations

Country	Name	City	State
Austria	Medizinische Universitat Graz	Graz
Austria	AKh - Allgemeines Krankenhaus der Stadt Linz GmbH	Linz
Belgium	Ziekenhaus Oost Limburg	Genk
Belgium	Grand Hopital De Charleroi	Gilly
Belgium	Jessa Hospital	Hasselt
Belgium	UCL de Mont Godinne	Yvoir
France	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	Orleans
France	Groupement Hospitalier Pitie Salpetriere	Paris 13
France	Centre Hospitalier Universitaire de Poitiers	Poitiers
France	Centre Hospitalier de Saintonge	Saintes Cedex
France	Clinique Saint Gatien	Tours
France	Centre Hospitalier Bretagne Atlantique	Vannes
Germany	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	Dusseldorf
Germany	Cardioangiologisches Centre Bethanien	Frankfurt
Germany	Herz- und Gefäßzentrum am Krankenhaus Neu-Bethlehem	Goettingen
Germany	St. Marienkrankenhaus Siegen	Siegen
Ireland	University Hospital Galway	Galway
Ireland	Bon Secours Hospital	Tralee
Italy	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
Korea, Republic of	Seoul National University Bundang Hospital	Gyeonggi-Do
Korea, Republic of	Korea University Anam Hospital	Seoul
Korea, Republic of	Samsung Medical Center	Seoul
Korea, Republic of	Seoul National University Hospital	Seoul
Korea, Republic of	Yonsei University Severance Hospital	Seoul
Norway	Akershus Universitetssykehus HF	Lorenskog
Portugal	Hospital Professor Doutor Fernando Fonseca, EPE	Amadora
Portugal	Centro Hospitalar do Alto Ave, EPE	Guimaraes
Portugal	CHLN, EPE Hospital de Santa Maria	Lisbon
Portugal	CHLO, EPE, Hospital S. Francisco Xavier	Lisbon
Portugal	Hospital dos SAMS	Lisbon
Spain	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	Merida
Spain	Hospital Universitario Nuestra Senora de Candelaria	Santa Cruz de Tenerife
Spain	Hospital Clinico Universitario Valladolid	Valladolid
Spain	Hospital Virgen de la Concha	Zamora
Sweden	Skanes Universitetssjukhus	Lund
Sweden	St Gorans Sjukhus	Stockholm
Switzerland	Universitatsspital Basel	Basel
United Kingdom	Morriston Hospital	Swansea

Sponsors (1)

Lead Sponsor	Collaborator
Boston Scientific Corporation

Countries where clinical trial is conducted

Austria,  Belgium,  France,  Germany,  Ireland,  Italy,  Korea, Republic of,  Norway,  Portugal,  Spain,  Sweden,  Switzerland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	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