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Completed

NCT Number: NCT06697145

Assessment of the Durability of Cardioneuroablation Using Physiological Indices of Heart Rate Reactivity

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.

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Key information

Conditions

Syncope, Vasovagal, Neurally-Mediated Autonomic Nervous System Diseases Consciousness Disorders Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Orthostatic Intolerance Pathological Conditions, Signs and Symptoms Primary Dysautonomias Signs and Symptoms Syncope Syncope, Vasovagal Unconsciousness

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Wroclaw Medical University

Wroclaw, Lower Silesian Voivodeship, 50-556, Poland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • pregnancy
  • known atropine hypersensitivity

Treatment and study plan

Cardioneuroablation

Procedure

Ablation of parasympathetic ganglia of the heart

Primary outcomes

  1. Change in degree of parasympathetic denervation (%)

    Time frame: 12 months

Secondary outcomes

  1. Change in heart rate (beats/min)

    Time frame: 12 months

  2. Change in heart rate variability (ms)

    Time frame: 12 months

  3. Change in cardiac barosensitivity (ms/mmHg)

    Time frame: 12 months

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

    Time frame: 12 months

  5. Time to recurrence of syncopal event (days

    Time frame: 12 months

Sponsors and collaborators

Lead sponsor

Wroclaw Medical University

Other

Registry information

Official study title

Assessment of the Durability and Clinical Effectiveness of Parasympathetic Denervation Following Cardioneuroablation Using Physiological Indices of Heart Rate Reactivity

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Nov 20, 2024
Registry last updated
Mar 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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