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NCT04149886: GAPS

Cardiac Ganglionated Plexus Ablation Before Permanent Pacemaker Implantation in Patients With Sick Sinus Syndrome

Status unknown NA Last updated 4 November 2019
What this trial tests

NA trial testing cardiac ganglion plexus ablation(cardioneuroablation) in Cardioneuroablation in 100 participants. Status unknown.

Timeline
28 October 2019
Primary endpoint
27 October 2020
27 October 2021

Quick facts

Lead sponsorChina National Center for Cardiovascular Diseases
PhaseNA
StatusStatus unknown
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingsingle
Primary purposetreatment
Enrollment100
Start date28 October 2019
Primary completion27 October 2020
Estimated completion27 October 2021
Sites2 locations across China

Drugs / interventions tested

Conditions studied

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):

  1. 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
  2. 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
  3. Cardioneuroablation: A Comprehensive Review
    Conti S, Porto A, Zappulla P, Sgarito G. · · 2026

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Other trials of cardiac ganglion plexus ablation(cardioneuroablation)

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Other China National Center for Cardiovascular Diseases trials

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Data sources for this page

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Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing