Imaging Study of Lead Implant for His Bundle Pacing (NCT03294317) | Clinical Trial Compass
CompletedNot Applicable
Imaging Study of Lead Implant for His Bundle Pacing
United States70 participantsStarted 2017-11-29
Plain-language summary
The purpose of this research study is to assess the implant success proportion of the Medtronic SelectSecure MRI SureScan Model 3830 pacing lead at the bundle of His for His bundle pacing.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Subject has a Class I or II indication for implantation of an implantable pacemaker
* Subject (or legally authorized representative) has signed and dated the study-specific Consent Form
* Subject is 18 years of age or older, or is of legal age to give informed consent per local and national law
* Subject is expected to remain available for follow-up visits
Exclusion Criteria:
* Subject is contraindicated for Cardiac CT
* Subject has an existing or prior pacemaker, ICD or CRT device implant
* Subject is intended to receive an implant of a LV lead or CRT device
* Subject life expectancy is less than 1 year
* Pregnant women or breastfeeding women, or women of child bearing potential and who are not on a reliable form of birth regulation method or abstinence
* Subjects with exclusion criteria required by local law (e.g. age or other)
* Subject with a medical condition that precludes the patient from participation in the opinion of the investigator
* Subject is enrolled in a concurrent study that may confound the results of this study.