Permanent Pacemaker Implantation or Cardioneuroablation in Sinus Node Dysfunction

NCT05196126 | Unknown DMC

• 1 other identifier: SANOK
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 4

Brief 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.

Conditions

Sinus Node Dysfunction

Keywords

cardioneuroablation; pacemaker; sinus node dysfunction; bradycardia; extracardiac vagal nerve stimulation; ECG monitoring; quality of life

Outcome Measures

Primary Outcomes (2)

• Number of Participants Who Had Freedom From Bradycardia Symptoms at 6 months

  Number of participants who had freedom from bradycardia symptoms at 6 months - for all participants - who had CNA versus PM implanation versus no procedure performed. Trial - patient is randomized to standard PM implatantion (Group A) or CNA procedure (Group B). Registry (Group C) - patient refused participation in the trial, and decided to have share-decision making procedure (CNA, PM implanatation) or no intervention at all - taking into account evidence, risk-benefit assesments, expected outcomes and individual patient preferences.

  6 months

• Number of Participants with Pacemaker Implantation at 6 months

  Number of participants with PM implantation at 6 months

  6 monhts

Secondary Outcomes (8)

• Number of Events of Procedural Complications

  0-6 months

• Number of Participants With Post-ablation Inducibility of Sinus Arrest and/or AV Block by Vagal Nerve Stimulation

  1 day (peri-procedural)

• Effect of CNA on Quality of Life Parameters Based on EQ-5D-5L Questionnaire

  0, 3, 6, 9, 12 months

• Effect of CNA on Quality of Life Parameters Based on SF-36 Questionnaire

  0, 3, 6, 9, 12 months

• Effect of CNA on Fatigue Based on Modified Fatigue Impact Scale (MFIS)

  0, 6, 12 months

Study Arms (2)

Group A - PACEMAKER

ACTIVE COMPARATOR

According with ESC indications for elective pacemaker implantation due to SND will referred for PM implantation.

Procedure: Permament pacemaker implantation

Group B - CARDIONEUROABLATION

EXPERIMENTAL

According with ESC indications for elective PM implantation due to SND will referred for ICM/ILR implantation or prolonged ECG monitoring. Within 4 weeks patient will be screened by interdisciplinary team and autonomic tests (including atropine tests) will be performed. Than, based on atropine tests, electrophysiologic study and extracardiac vagal nerve stimulation, final indication for cardioneuroablation will be established. Biatrial, binodal cardioneuroablation will be performed with anatomical approach with bilateral extra cardiac vagal nerve stimulation during general anesthesia. Than, patient will be closely monitored and indication for PM implantation will be verified.

Procedure: Cardioneuroablation

Interventions

Permament pacemaker implantation PROCEDURE

PM implantation

Group A - PACEMAKER

Cardioneuroablation PROCEDURE

Biatrial, binodal CNA procedure with anatomical approach will be performed with pre- and post procedural extracardiac vagal nerve stimulation in general anesthesia.

Also known as: Extracardiac vagal nerve stimulation

Group B - CARDIONEUROABLATION

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age, 18-75 years
• Sinus node dysfunction/disease fulfilling criteria for elective pacemaker implantation according to current ESC guidelines (I, IIa, and IIb )
• Optimization of chronic disease treatment
• Ability to provide informed consent to participate in the study
• Ability to understand patient information.

You may not qualify if:

• Contraindications to invasive and noninvasive procedures used in the study
• Uncontrolled endocrine and systemic disorders
• Persistent atrial fibrillation
• Dilated cardiomyopathy
• Severe congenital heart valve disease or cardiomyopathy
• Functional NYHA class III/IV
• Left ventricular ejection fraction \<35%
• Left atrial diameter \>50 mm
• Previous catheter ablation
• Contraindications to anticoagulant treatment
• Contraindications to catheter ablation
• Chronic, advanced two- or third-degree atrioventricular block associated with structural heart disease
• Contraindications to noninvasive tests
• Pregnancy and lactation
• Previous cardiac surgery

Sponsors & Collaborators

• Stec, Sebastian, MD, PhD, FESC: lead
• KCRI: collaborator

Study Sites (4)

Center of Interventional Cardiology, Electrotherapy and Angiology G.V.M. Carint

Ostrowiec Świętokrzyski, 27-400, Poland

NOT YET RECRUITING

Medical Center SABAMED

Rzeszów, Poland

RECRUITING

Subcarpatian Center for Cardiovascular Interventions, Laboratory of Electrophysiology, Cardioneuroablation, Ablation, Arrhythmia and Heart Electrostimulation, G.V.M. Carint

Sanok, 38-500, Poland

RECRUITING

Department of Cardiology, Laboratory of Invasive Electrophysiology, 4th Military Teaching Hospital in Wroclaw

Wroclaw, 50-07, Poland

NOT YET RECRUITING

MeSH Terms

Conditions

Sick Sinus Syndrome; Bradycardia

Condition Hierarchy (Ancestors)

Arrhythmia, Sinus; Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Heart Block; Cardiac Conduction System Disease; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Sebastian Stec, MD, PhD

  Medical Center SABAMED Medicans

  STUDY CHAIR

Central Study Contacts

Sebastian Stec, MD, PhD

CONTACT

+48600298022; smstec@wp.pl

Edyta Stodółkiewicz-Nowarska, MD PhD

CONTACT

785885425; edytastod@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Stec Sebastian MD, PhD, FESC

Study Record Dates

• First Submitted: October 14, 2021
• First Posted: January 19, 2022
• Study Start: June 1, 2022
• Primary Completion: May 31, 2024
• Study Completion: June 30, 2024
• Last Updated: March 7, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

PL (4)