- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01890512
INGENIO MRI/ FINELINE II Pacing System Data Collection in Patients Undergoing MRI (INFINITE-MRI)
INGENIO MRI/ FINELINE II ImageReadyTM Pacing System Data Collection in Patients Undergoing Magnetic Resonance Imaging
Study Overview
Status
Conditions
Detailed Description
Objective of the INFINITE MRI Study is to collect data on the ImageReady MR Conditional Pacing System in subjects undergoing a magnetic resonance scan (MRI).
The ImageReady system has CE mark and enrolled patients will undergo MRI scan under the labeled Conditions of Use. Subjects considered eligible for this studty are already implanted with the system according to standard medical guidelines for PM implantation.
The study is aimed at providing confirmatory data of no impact of MRI on device function, lead parameters and patient conditions. The study will collect standard device measurement through device interrogation pre- and post- MRI scan. MRI scan in this study is a non-clinically indicated procedure and is not planned for diagnostic purposes.
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 where requested.
The study has no primary endpoint and is not hypothesis driven.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
-
Nieuwegein, Netherlands, 3435CM
- St. Antonius Ziekenhuis
-
Zwolle, Netherlands
- Isala Klinieken
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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 the 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), or accessories (see Table 5.1-1) 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 pulse generator location outside of left or right pectoral regions;
- Patients implanted with other cardiac-related implanted devices or accessories other than the ImageReadyTM MR Conditional Pacing System;
- Abandoned leads or PGs;
- Evidence of a fractured lead or compromised PG-lead system integrity;
- Low life expectancy (< 1 year);
- Severe comorbidities that, according to clinical judgment, pose patient at risk to undergo MRI;
- Pregnant women or women of childbearing potential
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
---|
ImageReady Pacemaker
patients previously implanted with a Boston Scientific MR Conditional pacemaker(ImageReady)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of MRI Related Patient Adverse Events and/or Adverse Device Effects During MRI Visit
Time Frame: one month
|
The study is aimed at providing confirmatory data of no impact of MRI on device function and patient conditions. Confirmation of no MRI related patient adverse events and/or adverse device effects during MRI visit are assessed as follows:
|
one month
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- C1897
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Bradycardia
-
Augusta UniversityCompletedFetal BradycardiaUnited States
-
University of Maryland, BaltimoreCompleted
-
Chun Chieh WangEnrolling by invitation
-
University of Sao Paulo General HospitalCompletedFetal Bradycardia | Hypertonic Uterine | CatecholaminesBrazil
-
University of ExeterRoyal Devon and Exeter NHS Foundation TrustCompletedSVT | Vagal BradycardiaUnited Kingdom
-
Abbott Medical DevicesCompletedStandard Bradycardia Pacing IndicationFrance, Germany, Italy, Japan
-
Medical University of GdanskCompletedBradycardia During Pulling of EyeballPoland
-
Medtronic Cardiac Rhythm and Heart FailureCompleted
-
South Western Ambulance Service NHS Foundation...Royal Devon and Exeter NHS Foundation Trust; Academic Health Science CentresCompletedEmergencies | SVT | Vagal BradycardiaUnited Kingdom
-
Unyime ItukRecruitingFetal Heart Rate or Rhythm Abnormality Affecting Fetus | Fetal Bradycardia Complicating Labor and Delivery | Fetal Bradycardia During LaborUnited States