Clinical trial NCT06038123: China 3T MRI Study
Official title: China CIED 3.0T MRI Performance Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bradycardia
Tachycardia
Heart Failure
Lead sponsor: Medtronic Cardiac Rhythm and Heart Failure
Sponsor class: INDUSTRY
First posted: 2023-09-14
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of the China CIED 3.0T MRI Performance Study is to confirm safety of SureScan CIED in the clinical 3.0T MRI environment when subjects receive MRI scans. ll subjects will have required follow-up visits at baseline, MRI visit, 1-month post-MRI. The MRI scans will occur at the MRI visit. The MRI scan region will be determined by investigator according to the subject's clinical condition.


Eligibility criteria: Inclusion Criteria:

* Subjects who were implanted an SureScan system CIED over 6 weeks at the time of signing ICF.
* Subjects who are able and willing to undergo elective MRI scanning without sedation.
* Subjects who were implanted an SureScan system CIED in the pectoral region.
* Subjects who are geographically stable and available for follow-up at the study site for the length of the study.
* Subjects who are at least 18 years of age (or older, if required by local law).

Exclusion Criteria:

* Subjects who require a legally authorized representative to obtain informed consent.
* Subjects with abandoned or capped leads.
* Subjects who require an indicated MRI scan, other than those specifically described in the China CIED 3.0T MRI performance study, before the 1-month post-MRI follow-up.
* Subjects with a non-MRI compatible device (such as neurostimulators) or material implant (e.g., non-MRI compatible sternal wires, neurostimulators, biostimulators, metals or alloys).
* Subjects with medical conditions that preclude the testing required by the CIP or limit study participation.
* Subjects who are enrolled or intend to participate in another clinical trial (of an investigational drug or device, new indication for an approved drug or device, or requirement of additional testing beyond standard clinical practice) during the SureScan study. Co-enrollment in concurrent trials is only allowed when documented pre-approval is obtained from the Medtronic study manager.
* Female patient who is pregnant, or of childbearing potential and not on a reliable form of birth control. Women of childbearing potential are required to have a negative pregnancy test within seven (7) days prior to device implant.

Primary outcomes:
measure: The occurrence of an MRI-related event for CIED
timeFrame: The event will be collected within 30 days after MRI visit.
Secondary outcomes:
measure: The changes in atrial and ventricular pacing capture thresholds of APCT from pre-MRI to 1-month post-MRI scan.
timeFrame: The evaluation will be compared from pre-MRI to 1-month post-MRI scan
measure: The changes in atrial and ventricular pacing capture thresholds of VPCT from pre-MRI to 1-month post-MRI scan.
timeFrame: The evaluation will be compared from pre-MRI to 1-month post-MRI scan
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Nanfang Hospital Southern Medical University
state: Guangdong
city: Zunyi
country: China
facility: Affiliated Hospital of Zunyi Medical University
state: Guizhou
city: Shanghai
country: China
facility: Shanghai Tongren Hospital
state: Shanghai
city: Taiyuan
country: China
facility: Shanxi Cardiovascular Hospital
state: Shanxi
city: Urumqi
country: China
facility: The First Affiliated Hospital of Xinjiang Medical University
state: Xinjiang
Study officials:
References: