Imaging Study of Lead Implant for His Bundle Pacing
Completed
Conditions studied: Cardiac Pacemaker, Artificial
In brief
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.
Key facts
- Study ID
- NCT03294317
- Run by
- Medtronic Cardiac Rhythm and Heart Failure
- People needed
- 70
- Starts
- 2017-11-29
- Expected to finish
- 2020-01-24
- Last updated by the study team
- 2021-06-01
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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.
Where it is running
- Indiana University - Krannert Institute of Cardiology — Indianapolis, Indiana, United States
- Geisinger Wyoming Valley Medical Center — Wilkes-Barre, Pennsylvania, United States
- Virginia Commonwealth University Health System — Richmond, Virginia, United States
Full record on ClinicalTrials.gov
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