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Permanent Pacemaker Implantation or Cardioneuroablation in Sinus Node Dysfunction — SANOK  

Sinus Node Dysfunction Clinical Trial

Official title:
Comparison of Strategies for Permanent Pacemaker Implantation and/or Cardioneuroablation in Patients With Sinus Node Dysfunction: a Noncommercial Physician-initiated Randomized Controlled Trial

Clinical Trial Summary

This is a noncommercial, physician-initiated, monitored, multicenter, prospective randomized clinical trial, a proof-of-concept study, investigating a treatment strategy only. The study will use medical products applied for invasive and nonivasive procedures performed at the participating centers.

Clinical Trial Description

All patients meeting the inclusion criteria and not meeting the exclusion criteria will be invited to participate in the study. The patient will receive an informed consent form describing the study protocol. After speaking to the investigator and receiving detailed answers to all questions, the patient will sign the written informed consent form to participate in the study or will choose to opt out of randomization and to be included in the registry only. Premenopausal women who will provide consent to participate in the study will undergo a pregnancy test before any invasive procedure. During the 12-month study duration, the use of effective contraception is recommended. The patient will be asked to complete the questionnaires on bradycardia symptoms and quality of life (QOL). Any patient included in the study will be randomized into group A or group B. Patients included in the registry (group C) will undergo patient-tailored interventions and treatments through shared decision-making with a possibility of permanent cardiac pacing (subgroup CA), vagal nerve stimulation (VNS) according to the protocol and cardioneuroablation (subgroup CB), as well as observation (subgroup CO). ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05196126
Study type Interventional
Source Stec, Sebastian, MD, PhD, FESC
Contact Sebastian Stec, MD, PhD
Phone +48600298022
Email smstec@wp.pl
Status Recruiting
Phase N/A
Start date June 1, 2022
Completion date June 30, 2024
View Details
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