Imaging Study of Lead Implant for His Bundle Pacing
Status: | Active, not recruiting |
---|---|
Conditions: | Cardiology |
Therapuetic Areas: | Cardiology / Vascular Diseases |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 3/8/2019 |
Start Date: | November 29, 2017 |
End Date: | December 2019 |
Imagining Study of Lead Implant for His Bundle Pacing
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.
Medtronic SelectSecure MRI SureScan Model 3830 pacing lead at the bundle of His for His
bundle pacing.
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.
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.
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.
We found this trial at
3
sites
Indianapolis, Indiana 46202
Principal Investigator: Gopi Dandamudi, MD
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Richmond, Virginia 23298
Principal Investigator: Jayanthi Koneru, MBBS
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Wilkes-Barre, Pennsylvania 18711
Principal Investigator: Pugazhendhi Vijayaraman, MD
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