Clinical trial NCT02166606: INGEVITY™ Observational Trial
Official title: INGEVITY™ Observational Trial: Assessment of Routine Experience and Magnet Resonance Imaging (MRI) Usage With a New Lead for Bradycardia Pacing
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bradycardia
Lead sponsor: Boston Scientific Corporation
Sponsor class: INDUSTRY
First posted: 2014-06-18
Enrollment: 1184
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Percentage of Leads Free From Complication
timeFrame: 91 calendar days post-implant
Secondary outcomes:
Other outcomes:
measure: MRI Procedures Through 12 Months Post-Implant
timeFrame: 365 calendar days post implant
Locations:
city: Graz
country: Austria
facility: Medizinische Universitat Graz
city: Linz
country: Austria
facility: AKh - Allgemeines Krankenhaus der Stadt Linz GmbH
city: Genk
country: Belgium
facility: Ziekenhaus Oost Limburg
city: Gilly
country: Belgium
facility: Grand Hopital De Charleroi
city: Hasselt
country: Belgium
facility: Jessa Hospital
city: Yvoir
country: Belgium
facility: UCL de Mont Godinne
city: Avignon
country: France
facility: Clinique Rhone Durance
city: Caen
country: France
facility: Hopital Prive Saint Martin
city: Cherbourg
country: France
facility: Centre Hospitalier du Contentin
city: Jossigny
country: France
facility: Centre Hospitalier de Marne La Vallee
city: Lomme
country: France
facility: Hopital Saint Philibert
city: Massy
country: France
facility: Hopital Prive Jacques Cartier
city: Melun
country: France
facility: Clinique Les Fontaines
city: Moulins
country: France
facility: Centre Hospitalier de Moulins
city: Nantes
country: France
facility: Le Confluent - Nouvelles Cliniques Nantaises
city: Orleans
country: France
facility: Hopital Regional Orleans La Source
city: Paris 13
country: France
facility: Groupement Hospitalier Pitie Salpetriere
city: Poitiers
country: France
facility: Centre Hospitalier Universitaire de Poitiers
city: Saintes Cedex
country: France
facility: Centre Hospitalier de Saintonge
city: Tours
country: France
facility: Clinique Saint Gatien
city: Vannes
country: France
facility: Centre Hospitalier Bretagne Atlantique
city: Berlin
country: Germany
facility: Charite, Universitatsmedizin Berlin, Campus Benjamin Franklin, Klinik fur Kardiologie und Pulmologie
city: Berlin
country: Germany
facility: Unfallkrankenhaus Berlin, Klinik fur Innere Medizin
city: Bernau
country: Germany
facility: Immanuel Klinikum Bernau/Herzzentrum Brandenburg
city: Dusseldorf
country: Germany
facility: Universitatsklinikum Dusseldorf, Klinik fur Kardiovaskulare Chrirurgie
city: Frankfurt
country: Germany
facility: Cardioangiologisches Centre Bethanien
city: Goettingen
country: Germany
facility: Herz- und Gefäßzentrum am Krankenhaus Neu-Bethlehem
city: Siegen
country: Germany
facility: St. Marienkrankenhaus Siegen
city: Galway
country: Ireland
facility: University Hospital Galway
city: Tralee
country: Ireland
facility: Bon Secours Hospital
city: Brescia
country: Italy
facility: Fondazione Poliambulanza
city: Cosenza
country: Italy
facility: Ospedale Annunziata
city: Frosinone
country: Italy
facility: Ospedale Spaziani Frosinone
city: Ragusa
country: Italy
facility: Ospedale Guzzardi di Vittoria
city: Roma
country: Italy
facility: Policlinico Casilino
city: Treviso
country: Italy
facility: Azienda ULSS 9 Treviso
city: Verona
country: Italy
facility: Ospedale Borgo Trento
city: Gyeonggi-Do
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
city: Seoul
country: Korea, Republic of
facility: Korea University Anam Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: Yonsei University Severance Hospital
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Lorenskog
country: Norway
facility: Akershus Universitetssykehus HF
city: Amadora
country: Portugal
facility: Hospital Professor Doutor Fernando Fonseca, EPE
city: Guimaraes
country: Portugal
facility: Centro Hospitalar do Alto Ave, EPE
city: Lisbon
country: Portugal
facility: CHLO, EPE, Hospital S. Francisco Xavier
city: Lisbon
country: Portugal
facility: CHLN, EPE Hospital de Santa Maria
city: Lisbon
country: Portugal
facility: Hospital dos SAMS
city: Barcelona
country: Spain
facility: Hospital Clinic de Barcelona
city: Madrid
country: Spain
facility: Hospital Universitario Infanta Leonor
city: Madrid
country: Spain
facility: Hospital Universitario Ramon y Cajal
city: Majadahonda
country: Spain
facility: Hospital Puerta de Hierro
city: Merida
country: Spain
facility: Hospital de Merida
city: Santa Cruz de Tenerife
country: Spain
facility: Hospital Universitario Nuestra Senora de Candelaria
city: Valladolid
country: Spain
facility: Hospital Clinico Universitario Valladolid
city: Zamora
country: Spain
facility: Hospital Virgen de la Concha
city: Lund
country: Sweden
facility: Skanes Universitetssjukhus
city: Stockholm
country: Sweden
facility: St Gorans Sjukhus
city: Basel
country: Switzerland
facility: Universitatsspital Basel
city: Swansea
country: United Kingdom
facility: Morriston Hospital
Study officials:
affiliation: Nouvelles Cliniques Nantaises Cardiologie / Médecins du pôle - Unité de Soins et de Cardiologie Interventionnelle 4 rue Eric Tabarly 44277 Nantes cedex 2 France
name: Daniel Gras, MD
role: PRINCIPAL_INVESTIGATOR
name: John doe, MD
role: PRINCIPAL_INVESTIGATOR
References: