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NCT03601754
Effectiveness of Closed Loop Stimulation (CLS) With His Bundle Lead Placement
NA trial testing Treadmill/Bicycle exercise testing in Sinus Node Dysfunction in 5 participants. Completed in 31 January 2019.
31 January 2019
Quick facts
| Lead sponsor | NYU Langone Health |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | diagnostic |
| Enrollment | 5 |
| Start date | 19 July 2018 |
| Primary completion | 31 January 2019 |
| Estimated completion | 31 January 2019 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Treadmill/Bicycle exercise testing
Conditions studied
- Sinus Node Dysfunction — all drugs for Sinus Node Dysfunction →
Sponsor
NYU Langone Health — full company profile →
Who can join
Adults 18 to 100, any sex, with Sinus Node Dysfunction. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT03601754
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Sinus Node Dysfunction
Currently open trials in the same condition.
- NCT07209852 — Safety, Performance, and Clinical Benefit of Pacing the Left Bundle Branch Area - Post-Market Clinical Follow-up · recruiting
Other NYU Langone Health trials
Trials by the same sponsor.
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- NCT06637852 — Sexual and Urinary Function Improvement for Cancer Survivors · NA · not yet recruiting
- NCT06236087 — Overdose Prevention Centers and Behavioral Health · not yet recruiting
- NCT06462027 — Packed Red Blood Cell Transfusion During Cardiac Arrest · Phase 1 · suspended
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03601754 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by NYU Langone Health
- Last refreshed: 18 November 2019
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03601754.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing