Imaging Study of Lead Implant for His Bundle Pacing ((IMAGE-HBP))
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About
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.
Full description
The study will evaluate implant lead electrical measurements and changes over time, estimate the correlation between lead location and selective vs non-selective His bundle pacing, and estimate the correlation between long-term lead performance and implant characteristics. Data from the study may be used to standardize the implant workflow to help improve the ease and predictability of His bundle pacing implants.
Enrollment
Sex
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Volunteers
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.
Trial design
70 participants in 1 patient group
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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