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

Assessment of the Durability and Clinical Effectiveness of Parasympathetic Denervation Following 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.

Study Overview

• Status: Completed
• Conditions: Syncope, Vasovagal, Neurally-Mediated
• Intervention / Treatment: Procedure: Cardioneuroablation

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Poland
  • Dolnoslaskie
    • Wroclaw, Dolnoslaskie, Poland, 50-556
      • Wroclaw Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

• pregnancy
• known atropine hypersensitivity

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cardioneuroablation	Procedure: Cardioneuroablation; Ablation of parasympathetic ganglia of the heart

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change in degree of parasympathetic denervation (%)	12 months

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Wroclaw Medical University

Study record dates

Study Major Dates

• Study Start (Actual): November 23, 2021
• Primary Completion (Actual): December 31, 2024
• Study Completion (Actual): December 31, 2024

Study Registration Dates

• First Submitted: November 17, 2024
• First Submitted That Met QC Criteria: November 17, 2024
• First Posted (Actual): November 20, 2024

Study Record Updates

• Last Update Posted (Actual): March 30, 2025
• Last Update Submitted That Met QC Criteria: March 26, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Neurobehavioral Manifestations; Primary Dysautonomias; Autonomic Nervous System Diseases; Orthostatic Intolerance; Consciousness Disorders; Unconsciousness; Syncope; Syncope, Vasovagal
• Other Study ID Numbers: KB-331/2022

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No