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NCT03876652
Pacemaker Effect With Closed Loop Sensor in Neuromodulated Syncope Refractory to Medical Therapy
NA trial testing Pacemaker with Closed Loop Stimulation (CLS) in Syncope in 48 participants. Completed in 1 March 2022.
15 April 2021
Quick facts
| Lead sponsor | CES University |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 48 |
| Start date | 22 November 2017 |
| Primary completion | 15 April 2021 |
| Estimated completion | 1 March 2022 |
| Sites | 2 locations across Colombia |
Drugs / interventions tested
- Pacemaker with Closed Loop Stimulation (CLS)
Conditions studied
- Syncope — all drugs for Syncope →
Sponsor
CES University
Who can join
18 and older, any sex, with Syncope. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Vasovagal syncope is an entity frequently in the emergency services, its treatment includes pharmacological and non-pharmacological measures, and in some severe cases, requires the implantation of cardiac stimulation devices, specifically, those pacemakers that have closed-loop sensors (CLS). This research is an intervention study, multi-institutional, randomized and double blind that will be carried out in patients older than 18 years, with a diagnosis of neurally mediated type 1, 2A or 2B syncope documented in a tilting table test, who have had at least 2 syncope in the last year and that significantly affects the quality of life despite the use of pharmacological and non-pharmacological non-interventionist therapy. This study aims to evaluate the effect of cardiac pacing therapy with CLS pacemakers on quality of life, recurrence of syncope and pre-syncopal symptoms in patients with a diagnosis of neurally mediated syncope in this group of patients.
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 NCT03876652
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Syncope
Currently open trials in the same condition.
- NCT05896592 — Comparison of the Efficacy and Safety of Cardioneuroablation to Permanent Pacing in Patients With an Implanted Pacemaker · NA · recruiting
- NCT06526884 — Quasi-Randomized Evaluation of the UCLA Next Day Clinic (NDC) · NA · active not recruiting
- NCT06503653 — Creation of a Syncope Channel for Patients Admitted to the Emergency Department for Loss of Consciousness and Not Hospit · NA · active not recruiting
- NCT06288633 — Cardioneuroablation for Bradyarrhythmia · NA · recruiting
- NCT06087497 — The Z Stitch Early Bed Rest Assessment Study · NA · recruiting
Other CES University trials
Trials by the same sponsor.
- NCT06986343 — Impact of Palatal Expansion and Up-Locker Activator on Sleep and Pharyngeal Dimensions in Children · NA · enrolling by invitation
- NCT05923723 — Efficacy of a Dietary Intervention for the Treatment of Constipation in Institutionalized Older Adults. Medellín, 2023-2 · NA · completed
- NCT05310162 — Effect of the Intervention "Food, Fun and Family" on Sleep Bruxism in Children · NA · unknown
- NCT04602507 — Ivermectin in Adults With Severe COVID-19. · Phase 2 · terminated
- NCT03950700 — Bupivacaine in the Treatment of Postoperative Pain of Impacted Third Molar Extraction · Phase 4 · completed
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 NCT03876652 (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 CES University
- Last refreshed: 9 March 2022
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/NCT03876652.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing