Cardioneuroablation for Reflex Syncope

Summary

Aim. To assess the effects of cardioneuroablation (CNA) on cardiac autonomic regulation and syncope recurrences in patients with vasovagal syncope (VVS), and to compare this novel approach with standard non-pharmacological treatment.

Measurements.

1. Before CNA:

1. Detailed history taking and assessment of eligibility
2. Baseline 12-lead ECG for heart rate assessment, morphology and duration of the P wave and PR interval
3. 24-hour Holter ECG for heart rhythm (mean, minimal, maximal, pauses) and heart rate variability (HRV) assessment
4. Passive tilt test (70 degrees, 45 minutes) to fulfill inclusion criterion and to assess baseline autonomic parameters such as HRV and baroreflex sensitivity (BRS) using sequential method. These parameters will be calculated from 5 min recordings before and after orthostatic stress (tilt).
5. Atropine test - positive response to intravenous atropine in a dose of 2 mg defined as at least 30% increase in sinus rate compared with baseline value
6. Assessment of quality of life using the SF-36 questionnaire
7. Implantable Loop Recorder (ILR) implantation 2-3 days before CNA
2. During CNA:

1. Heart rate before and immediately after CNA
2. Episodes of bradycardia (sinus arrest or atrio-ventricular block) during application of RF to GP.
3. Standard electrophysiological parameters (sinus node recovery time, corrected sinus recovery time, refractory atrio-ventricular node, atrio-ventricular conduction - Wenckebach point, A-H and H-V intervals) will be assessed before an immediately after CNA
4. Atropine test (2 mg) will be repeated immediately after CNA.
3. After CNA:

1. 1-2 days after CNA standard ECG
2. Follow-up: 3, 12 and 24 months after CNA assessment of symptoms, 12 lead standard ECG, control of ILR, 24-hour Holter ECG, tilt test and atropine test will be performed. Additionally, quality of life will be assessed using SF-36 questionnaire

Anticipated results.

1. CNA performed with technique used in the present study is effective in \> 90% of patients.
2. CNA-induced changes in analysed ECG and autonomic parameters predict CNA efficacy

Conditions

• Syncope, Vasovagal

Interventions

PROCEDURE

Cardioneuroablation

The electroanatomical map of the right (RA) and left (LA) atrium will be created and anatomically-based ablation of GP will be performed. Ablation in the RA is started from the supero-posterior area (superior right atrial GP), to the middle-posterior area (posterior right atrial GP). In the LA, ablation is started at the site of the anterior right GP and is continued downwards along the anterior part of a common vestibulum of the right pulmonary veins (PV), opposite to the right-sided ablation lesions. Finally, area of right inferior GP, close to the RIPV is ablated under intracardiac echocardiography control. Using this technique, GP's located close to the left PV are not ablated. We use a pure anatomic approach without identification of GP.

Sponsors & Collaborators

• Centre of Postgraduate Medical Education

  lead OTHER

Principal Investigators

• Piotr Kulakowski, Prof. · Centre of Postgraduate Medical Education

• Roman Piotrowski, MD, PhD · Centre of Postgraduate Medical Education

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2018-11-01

Primary Completion

2022-02-15

Completion

2022-02-15

Countries

• Poland

Study Locations