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

NCT ID: NCT06697145

Last Updated: 2025-03-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-11-23

Study Completion Date

2024-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Syncope, Vasovagal, Neurally-Mediated

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Cardioneuroablation

Group Type EXPERIMENTAL

Cardioneuroablation

Intervention Type PROCEDURE

Ablation of parasympathetic ganglia of the heart

Interventions

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Cardioneuroablation

Ablation of parasympathetic ganglia of the heart

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* pregnancy
* known atropine hypersensitivity
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Wroclaw Medical University

OTHER

Sponsor Role lead

Responsible Party

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Piotr Niewinski, MD

MD, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Wroclaw Medical University

Wroclaw, Lower Silesian Voivodeship, Poland

Site Status

Countries

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Poland

Other Identifiers

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KB-331/2022

Identifier Type: -

Identifier Source: org_study_id

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