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NCT03601754 · ClinicalTrials.gov registry record · NA
Effectiveness of Closed Loop Stimulation (CLS) With His Bundle Lead Placement
A NA study, sponsored by NYU Langone Health.
- Completed
- Registry status
- NA
- Development phase
- 5
- Enrollment target
NCT03601754: Completed NA study, sponsored by NYU Langone Health.
NCT03601754 is a NA study that has completed, run by NYU Langone Health. The registered enrollment target is 5 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (100% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03601754, a NA study, has completed, sponsored by NYU Langone Health.
- COMPLETED
- Registry status
- NA
- Development phase
- 5 participants
- Enrollment target
Study Summary
This study is a prospective, non-randomized pilot study looking to evaluate the effectiveness of Closed Loop Stimulation (CLS) in sinus node dysfunction patients with HIS bundle placement. Patients with sinus node dysfunction who have previously received a Biotronik pacemaker with His bundle lead placement as part of routine care will be recruited for the study. A hand-grip exercise will be performed at the conclusion of bicycle exercise testing in order to assess the performance of CLS during isometric exercise. After the study exercise testing is completed, data will be collected from the pacemaker.
Primary Outcome
Ability to achieve adequate heart rate, defined as reaching upper sensor rate, during peak exertion
Interventions
- DIAGNOSTIC_TEST Treadmill/Bicycle exercise testing
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 5 participants |
| Start Date | 2018-07-19 |
| Est. Completion | 2019-01-31 |
| Phase | NA |
What the finished NCT03601754 record still lists
NCT03601754 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 5 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (100% lower).
The record links to 0 conditions, and to 1 intervention - of which Treadmill/Bicycle exercise testing is the first listed.
NCT03601754 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03601754 about?
NCT03601754 is a clinical study titled "Effectiveness of Closed Loop Stimulation (CLS) With His Bundle Lead Placement". This study is a prospective, non-randomized pilot study looking to evaluate the effectiveness of Closed Loop Stimulation (CLS) in sinus node dysfunction patients with HIS bundle placement. Patients with sinus node dysfunction who have previously received a Biotronik pacemaker with His bundle lead pl...
What is the current status of trial NCT03601754?
This trial is currently completed. It is a NA study. The enrollment target is 5 participants. The study started on 2018-07-19. Estimated completion is 2019-01-31.
What interventions are being tested in trial NCT03601754?
The interventions under investigation include: Treadmill/Bicycle exercise testing (DIAGNOSTIC_TEST).
Who is sponsoring clinical trial NCT03601754?
This trial is sponsored by NYU Langone Health, which has 1,164 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03601754's enrollment target sits among peer trials
5 1988th of 2000 higher than 5 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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