NCT06697145

Brief Summary

Cardioneuroablation is a novel treatment option for reflex-mediated syncope. It involves thermal destruction of neural tissue in the close proximity of heart using catheter introduced to the heart through vein in the groin. Effectiveness of the procedure is satisfactory, however, in some cases there is a possibility of the re-growth of previously ablated tissue. We aim to investigate whether this process could be traced by measurement of various physiological parameters related to heart rate reactivity. Additionally we intend to reveal whether changes in those parameters over time could influence clinical effeciveness of the procedure.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 23, 2021

Completed
3 years until next milestone

First Submitted

Initial submission to the registry

November 17, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 20, 2024

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

March 30, 2025

Status Verified

March 1, 2025

Enrollment Period

3.1 years

First QC Date

November 17, 2024

Last Update Submit

March 26, 2025

Conditions

Syncope, Vasovagal, Neurally-Mediated

Outcome Measures

Primary Outcomes (1)

  • Change in degree of parasympathetic denervation (%)

    12 months

Secondary Outcomes (5)

  • Change in heart rate (beats/min)

    12 months

  • Change in heart rate variability (ms)

    12 months

  • Change in cardiac barosensitivity (ms/mmHg)

    12 months

  • Change in hypoxic heart rate response (beats/min SpO2)

    12 months

  • Time to recurrence of syncopal event (days

    12 months

Study Arms (1)

Cardioneuroablation

EXPERIMENTAL
Procedure: Cardioneuroablation

Interventions

CardioneuroablationPROCEDURE

Ablation of parasympathetic ganglia of the heart

Cardioneuroablation

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • signed informed consent
  • sinus rhythm
  • clinical indications for cardioneuroablation for the treatment of vagally-mediated syncope

You may not qualify if:

  • pregnancy
  • known atropine hypersensitivity

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wroclaw Medical University

Wroclaw, Lower Silesian Voivodeship, 50-556, Poland

Location

MeSH Terms

Conditions

Syncope, Vasovagal

Condition Hierarchy (Ancestors)

Orthostatic IntolerancePrimary DysautonomiasAutonomic Nervous System DiseasesNervous System DiseasesSyncopeUnconsciousnessConsciousness DisordersNeurobehavioral ManifestationsNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

November 17, 2024

First Posted

November 20, 2024

Study Start

November 23, 2021

Primary Completion

December 31, 2024

Study Completion

December 31, 2024

Last Updated

March 30, 2025

Record last verified: 2025-03

Locations

PL(1)