N/A
N=20
INGENIO MRI/ FINELINE II Pacing System Data Collection in Patients Undergoing MRI
Bradycardia
Bottom Line
View on ClinicalTrials.gov: NCT01890512 ↗Enrolled (actual)
20
Serious AEs
15.0%
Results posted
Jun 2014
Primary outcome: Primary: Number of MRI Related Patient Adverse Events and/or Adverse Device Effects During MRI Visit — 0 number of MRI related patient adverse ev
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Boston Scientific Corporation
- Primary completion
- Jan 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of MRI Related Patient Adverse Events and/or Adverse Device Effects During MRI Visit |
— | — |
Summary
The INFINITE MRI Study is a prospective, non-randomized, multicenter, single arm study aimed at collecting data on ImageReady™ MR Conditional Pacing System (consisting of an INGENIO™ MRI or ADVANTIO™ MRI pacemaker with FINELINE™ II Sterox or FINELINE™ II Sterox EZ endocardial pacing lead(s)) when used in the Magnetic Resonance Imaging environment under the labeled Conditions of Use.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01890512). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.