search  
 


Home

Who are we?

Why
register?


Signup for
registration


Online registration

Log in to register
your trial


Search a trial

NRT en CCMO

Contact

NEDERLANDS





MetaRegister
van CCT (UK)


ISRCTN-Register
van CCT (UK)


INGENIO 2 /INGEVITY MRI device family data collection in patients undergoing Magnetic Resonance Imaging


- candidate number21093
- NTR NumberNTR4927
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR1-dec-2014
- Secondary IDsC1731 
- Public TitleINGENIO 2 /INGEVITY MRI device family data collection in patients undergoing Magnetic Resonance Imaging
- Scientific TitleINGENIO 2 /INGEVITY MRI device family data collection in patients undergoing Magnetic Resonance Imaging
- ACRONYMINFINITE 2 MRI
- hypothesisMagnetic resonance imaging (MRI) is now the imaging modality of choice for many neurological and musculoskeletal conditions. In the past, implanted cardiac devices including pacemakers (PM) have been contraindicated by MRI scanner, due to the potential for adverse effects. Boston Scientific INGENIO 2 pacemakers and INGEVITY MRI pacing leads (ImageReady™) have been labeled as a “MR Conditional Pacing System” when used in the MRI environment under the labeled Conditions of Use. Interest in collecting human data to confirm performance of this pacing system when used in MRI environments is high, with the collection of data from patients undergoing an MRI scan of key importance.
- Healt Condition(s) or Problem(s) studiedBradyarrhyhtmias, Hearth rhythm disorders
- Inclusion criteria• Age 18 or above, or above legal age and willing and capable of giving informed consent specific to national law • Patients already implanted with ImageReady™ MR Conditional Pacing System, according to standard medical guidelines for pacemaker implantation. • Willing and capable of participation to the procedures indicated in the protocol.
- Exclusion criteria• Patients implanted with other cardiac-related implanted devices or accessories other than the ImageReadyTM MR Conditional Pacing System • Low life expectancy (< 1 year) • Severe comorbidities that, according to clinical judgment, pose patient at risk to undergo MRI
- mec approval receivedno
- multicenter trialyes
- randomisedno
- group[default]
- TypeSingle arm
- Studytypeobservational
- planned startdate 1-mrt-2015
- planned closingdate30-sep-2015
- Target number of participants20
- InterventionsSubjects are enrolled when already implanted according to standard medical guidelines for pacemaker implantation and will undergo a Magnetic Resonance Imaging (MRI) scan under the labeled Conditions of Use.
- Primary outcomeThe study is aimed at providing confirmatory data of no impact of MRI on device function, lead parameters and patient conditions for the CE-marked ImageReady™ MR Conditional Pacing System when used under the labeled Conditions of Use.
- Secondary outcomenot applicable
- Timepoints- enrollment (after implant of pacemaker) - MRI visit (at least 6 weeks after pacemaker implant, according to Conditions of use) - standard of care follow up visit, one month after MRI visit.
- Trial web site
- statusstopped: trial finished
- CONTACT FOR PUBLIC QUERIESClinical Trial Manager Phone: +39 348 2502687 Giovanni Raciti
- CONTACT for SCIENTIFIC QUERIESDr. Lucas V.A. Boersma
- Sponsor/Initiator Guidant Europe SA / NV, a Boston Scientific Company
- Funding
(Source(s) of Monetary or Material Support)
Guidant Europe SA / NV, a Boston Scientific Company
- Publications
- Brief summary
- Main changes (audit trail)
- RECORD1-dec-2014 - 10-nov-2016


  • Indien u gegevens wilt toevoegen of veranderen, kunt u een mail sturen naar nederlands@trialregister.nl