N/A
N=70
Imaging Study of Lead Implant for His Bundle Pacing
Cardiac Pacemaker, Artificial
Bottom Line
View on ClinicalTrials.gov: NCT03294317 ↗Enrolled (actual)
70
Serious AEs
4.4%
Results posted
Jun 2021
Primary outcome: Primary: Implant Success — 75.36 % of subjects with successful implant
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- His bundle pacing (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
- Primary completion
- Apr 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Implant Success |
75.36 | — |
| SECONDARY Association Between the Lead Position and Selective vs. Nonselective HBP Occurrence at Implant |
1.27; 0.57 | — |
| SECONDARY Changes in His-bundle Pacing Capture Thresholds Over Time |
1.82 | — |
| SECONDARY Changes in Impedance Over Time |
429.72 | — |
| SECONDARY Changes in R-wave Amplitude Over Time |
4.10 | — |
| SECONDARY Changes in QRS Duration Over Time |
105.00 | — |
| SECONDARY Association Between Lead Location and Long-term Lead Electrical Performance |
0.070681015; 0.106436807 | — |
| SECONDARY Correlation Between His-bundle Pacing Capture Threshold at Implant and Long-term Lead Electrical Performance |
0.308729841 | — |
| SECONDARY Correlation Between Paced QRS Duration at Implant and Long-term Lead Electrical Performance |
-0.001329355 | — |
| SECONDARY Complications Related to the Procedure or the Lead for His Bundle Pacing |
4 | — |
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT03294317). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.