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NCT04149886: GAPS
Cardiac Ganglionated Plexus Ablation Before Permanent Pacemaker Implantation in Patients With Sick Sinus Syndrome
NA trial testing cardiac ganglion plexus ablation(cardioneuroablation) in Cardioneuroablation in 100 participants. Status unknown.
27 October 2020
Quick facts
| Lead sponsor | China National Center for Cardiovascular Diseases |
|---|---|
| Phase | NA |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | treatment |
| Enrollment | 100 |
| Start date | 28 October 2019 |
| Primary completion | 27 October 2020 |
| Estimated completion | 27 October 2021 |
| Sites | 2 locations across China |
Drugs / interventions tested
- cardiac ganglion plexus ablation(cardioneuroablation)
- Permanent pacemaker implantation
Conditions studied
- Cardioneuroablation — all drugs for Cardioneuroablation →
- Permanent Pacemaker Implantation — all drugs for Permanent Pacemaker Implantation →
- Sick Sinus Syndrome — all drugs for Sick Sinus Syndrome →
- Ganglionated Plexus — all drugs for Ganglionated Plexus →
Sponsor
China National Center for Cardiovascular Diseases — full company profile →
Who can join
Adults 14 to 75, any sex, with Cardioneuroablation or Permanent Pacemaker Implantation. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Different studies for cardiac ganglionated plexus(GP) ablation to treat vagal vascular syncope, sinus node dysfunction, and functional atrioventricular block have been published. Investigators have developed a more specific approach of cardiac, called cardioneuroablation . This treatment is based on a high-frequency stimulation (HFS) and/or anatomical landmarks to identify GPs in left atrium,which being targeted by radiofrequency catheter ablation. The feasibility of GPs ablation/cardioneuroablation has already been tested in our center in former studies in humans,with a favorable outcome for the patients involved. The results of the former studies have been submitted for publication. However, there are no prospective randomized studies to evaluate the efficacy and safety of atrial ganglionated plexus ablation for SSS before permanent pacemaker implantation. The purpose of this study of GAPS in humans is to evaluate the efficacy and safety of cardioneuroablation in patients of sick sinus syndrome before they receive a permanent pacemaker.
Publications & conference data
3 peer-reviewed publications reference this trial (live from Europe PMC):
-
Cardioneuroablation for the treatment of reflex syncope and functional bradyarrhythmias: A Scientific Statement of the European Heart Rhythm Association (EHRA) of the ESC, the Heart Rhythm Society (HRS), the Asia Pacific Heart Rhythm Society (APHRS) and the Latin American Heart R
Aksu T, Brignole M, Calo L, Debruyne P, et al · · 2024 · cited 45× · PMID 39082698 · DOI 10.1093/europace/euae206 -
Cardioneuroablation: Where are we at?
Pachon JC, Pachon EI, Aksu T, Gopinathannair R, et al · · 2023 · cited 27× · PMID 37361615 · DOI 10.1016/j.hroo.2023.02.007 -
Cardioneuroablation: A Comprehensive Review
Conti S, Porto A, Zappulla P, Sgarito G. · · 2026
Verify or expand the search:
- PubMed search for NCT04149886
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of cardiac ganglion plexus ablation(cardioneuroablation)
Trials testing the same drug.
- NCT05573178 — Different Catheter Ablation Strategy in Vasovagal Syncope · NA · completed
Other China National Center for Cardiovascular Diseases trials
Trials by the same sponsor.
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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 NCT04149886 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by China National Center for Cardiovascular Diseases
- Last refreshed: 4 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/NCT04149886.
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