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NCT03294317 · ClinicalTrials.gov registry record
Imaging Study of Lead Implant for His Bundle Pacing
A clinical trial of Cardiac Pacemaker, Artificial, sponsored by Medtronic Cardiac Rhythm and Heart Failure.
- Completed
- Registry status
- 70
- Enrollment target
- 3
- Study locations
NCT03294317: Completed study of Cardiac Pacemaker, Artificial, sponsored by Medtronic Cardiac Rhythm and Heart Failure.
NCT03294317 is a study of Cardiac Pacemaker, Artificial that has completed, run by Medtronic Cardiac Rhythm and Heart Failure. The registered enrollment target is 70 participants. The trial reports 3 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03294317, a study of Cardiac Pacemaker, Artificial, has completed, sponsored by Medtronic Cardiac Rhythm and Heart Failure.
- COMPLETED
- Registry status
- 70 participants
- Enrollment target
- 3
- Study locations
Study 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.
Primary Outcome
To determine the proportion implant successes from all subjects who undergo an implant attempt of a lead at the bundle of His for His bundle pacing. Implant success will be defined as the presence of a H wave on the implanted lead EGM and a His-bundle pacing capture threshold equal to or less than 2.5V at 1.0ms.
Conditions Studied
Interventions
- DEVICE His bundle pacing
Study Locations (3)
Indiana
- Indiana University - Krannert Institute of Cardiology - Indianapolis
Pennsylvania
- Geisinger Wyoming Valley Medical Center - Wilkes-Barre
Virginia
- Virginia Commonwealth University Health System - Richmond
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 70 participants |
| Start Date | 2017-11-29 |
| Est. Completion | 2020-01-24 |
What the finished NCT03294317 record still lists
NCT03294317 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 70 participants, a relatively small participant target.
The record links to 1 condition, with Cardiac Pacemaker, Artificial appearing as the primary indexed condition, and to 1 intervention - of which His bundle pacing is the first listed.
NCT03294317 reports a single indexed study location in Indiana, Pennsylvania, Virginia.
Frequently Asked Questions
What is clinical trial NCT03294317 about?
NCT03294317 is a clinical study titled "Imaging 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.
What is the current status of trial NCT03294317?
This trial is currently completed. The enrollment target is 70 participants. The study started on 2017-11-29. Estimated completion is 2020-01-24.
What conditions does trial NCT03294317 study?
This clinical trial studies the following conditions: Cardiac Pacemaker, Artificial.
What interventions are being tested in trial NCT03294317?
The interventions under investigation include: His bundle pacing (DEVICE).
Who is sponsoring clinical trial NCT03294317?
This trial is sponsored by Medtronic Cardiac Rhythm and Heart Failure, which has 115 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03294317 being conducted?
This trial has 3 study locations across Indiana, Pennsylvania, Virginia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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