Status:
COMPLETED
Imaging Study of Lead Implant for His Bundle Pacing
Lead Sponsor:
Medtronic Cardiac Rhythm and Heart Failure
Conditions:
Cardiac Pacemaker, Artificial
Eligibility:
All Genders
18+ years
Brief 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.
Detailed 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 co...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 29 2017
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
January 24 2020
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT03294317
Start Date
November 29 2017
End Date
January 24 2020
Last Update
June 1 2021
Active Locations (3)
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1
Indiana University - Krannert Institute of Cardiology
Indianapolis, Indiana, United States, 46202
2
Geisinger Wyoming Valley Medical Center
Wilkes-Barre, Pennsylvania, United States, 18711
3
Virginia Commonwealth University Health System
Richmond, Virginia, United States, 23298