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)


ImageReadyTM pacing system data collection in patients undergoing Magnetic Resonance Imaging.


- candidate number14434
- NTR NumberNTR3874
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR25-feb-2013
- Secondary IDsC1897 Boston Scientific
- Public TitleImageReadyTM pacing system data collection in patients undergoing Magnetic Resonance Imaging.
- Scientific TitleINGENIO MRI/ FINELINE II ImageReadyTM pacing system data collection in patients undergoing Magnetic Resonance Imaging.
- ACRONYMINFINITE MRI
- hypothesisThe study is aimed at providing confirmatory data of no impact of magnetic resonance on pacemaker device function, lead parameters and patient conditions for the CE-marked ImageReady™ MR Conditional Pacing System (INGENIO MRI pacemaker + FINELINE II leads)when used under the labeled Conditions of Use.
- Healt Condition(s) or Problem(s) studiedMagnetic resonance imaging (MRI) , MR conditional pacemakers, Bradyarrhyhtmias
- Inclusion criteria1. Age 18 or above, or above legal age and willing and capable of giving informed consent specific to national law;
2. Patients already implanted with ImageReady™ MR Conditional Pacing System, single or dual chamber, including INGENIO MRI or ADVANTIO MRI pulse generators with FINELINE II Sterox or FINELINE II Sterox EZ endocardial lead(s), according to standard medical guidelines for pacemaker implantation;
3. Willing and capable of participation to the procedures indicated in the protocol.
- Exclusion criteria1. Patients implanted with pulse generator location outside of left or right pectoral regions;
2. Patients implanted with other cardiac-related implanted devices or accessories other than the ImageReadyTM MR Conditional Pacing System;
3. Abandoned leads or pulse generators (PG);
4. Evidence of a fractured lead or compromised PG-lead system integrity;
5. Low life expectancy (< 1 year);
6. Severe comorbidities that, according to investigator clinical judgment, pose patient risk to undergo MRI;
7. Pregnant women or women of childbearing potential.
- mec approval receivedyes
- multicenter trialyes
- randomisedno
- groupParallel
- TypeSingle arm
- Studytypeobservational
- planned startdate 15-apr-2013
- planned closingdate15-jun-2013
- Target number of participants20
- InterventionsThere are no invasive interventions planned: INFINITE MRI Study collects data on the ImageReady™ MR Conditional Pacing System in subjects already implanted with the system according to standard medical guidelines for PM implantation and meets the labeled MRI Conditions of Use. Patients will undergo a MRI scan not for diagnostic purposes under the labeled Conditions of Use.
- Primary outcomeNo 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.

The study will collect standard device measurement through device interrogation pre- and post- MRI scan. Device measurements will include lead measurements (amplitude, threshold and impedance).

Data from this study will be used to support the evidence of clinical performance of the ImageReady™ MR Conditional Pacing System following a MRI scan when used under the labeled Conditions of Use, and may be used to support regulatory submissions for the approval of the system worldwide.
- Secondary outcomeN/A
- Timepoints1. Enrollment;
2. MRI visit;
3. One month follow up: 30 days +/-7 days after MRI visit.
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESDr. Lucas V.A. Boersma
- 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
- PublicationsN/A
- Brief summaryINGENIO MRI/ FINELINE II ImageReadyTM pacing system data collection in patients undergoing Magnetic Resonance Imaging (INFINITE MRI).

Background of the research:
Magnetic 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 pacemakers and FINELINE II Sterox endocardial 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.

Objective of the research:
Objective of the INFINITE MRI Study is to collect data on the ImageReady™ MR Conditional Pacing System in subjects already implanted with the system according to standard medical guidelines for PM implantation undergoing a MRI scan under the labeled Conditions of Use. The 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.

The study will collect standard device measurement through device interrogation done before MRI scan, post an MRI scan and at a 30 day follow up. Device measurement will include the following lead: amplitude, threshold and impedance.

Study Design:
The INFINITE MRI Study is a prospective, non-randomized non-blinded, multicenter, single arm study. Study will enroll up to 20 subjects at approximately two centers in Europe.

Study population:
Main inclusion criteria:
1. Age 18 or above, or above legal age and willing and capable of giving informed consent specific to national law;
2. Patients already implanted with ImageReady™ MR Conditional Pacing System, according to standard medical guidelines for pacemaker implantation;
3. Willing and capable of participation to the procedures indicated in the protocol.
Main exclusion criteria:
1. Patients implanted with other cardiac-related implanted devices or accessories other than the ImageReadyTM MR Conditional Pacing System;
2. Low life expectancy (< 1 year);
3. Severe comorbidities that, according to clinical judgment, pose patient at risk to undergo MRI.
- Main changes (audit trail)
- RECORD25-feb-2013 - 28-mei-2013


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