---
title: Permanent Pacemaker Implantation or Cardioneuroablation in Sinus Node Dysfunction
nct_id: NCT05196126
overall_status: UNKNOWN
phase: NA
sponsor: Stec, Sebastian, MD, PhD, FESC
study_type: INTERVENTIONAL
primary_condition: Sinus Node Dysfunction
countries: Poland
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT05196126.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT05196126"
ct_last_update_post_date: 2023-03-07
last_seen_at: "2026-05-12T07:33:11.685Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Permanent Pacemaker Implantation or Cardioneuroablation in Sinus Node Dysfunction

**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

**NCT ID:** [NCT05196126](https://clinicaltrials.gov/study/NCT05196126)

## Key Facts

- **Status:** UNKNOWN
- **Phase:** NA
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 60
- **Lead Sponsor:** Stec, Sebastian, MD, PhD, FESC
- **Collaborators:** KCRI
- **Conditions:** Sinus Node Dysfunction
- **Start Date:** 2022-06-01
- **Completion Date:** 2024-06-30
- **CT.gov Last Update:** 2023-03-07

## 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.

## Detailed 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).

## Eligibility

- **Minimum age:** 18 Years
- **Maximum age:** 75 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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
* Implanted pacemaker device
* Neck and chest abnormalities
* Myocardial infarction in the previous 6 months
* Percutaneous coronary intervention in the previous 3 months
* Estimated survival \<24 months
* Participation in another drug or medical device program
* Limited capacity to understand the study protocol or psychological disorders precluding informed consent to participate in the study.
* Any other uncontrolled chronic diseases, neck and chest abnormalities, or disorders that constitute a contraindication to catheter ablation, antiarrhytmic treatment, general anesthesia, or extracardiac vagal nerve stimulation (ECANS)
* Severe obesity (body mass index ≥40 kg/m2 )
```

## Arms

- **Group A - PACEMAKER** (ACTIVE_COMPARATOR) — According with ESC indications for elective pacemaker implantation due to SND will referred for PM 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.

## Interventions

- **Permament pacemaker implantation** (PROCEDURE) — PM implantation
- **Cardioneuroablation** (PROCEDURE) — Biatrial, binodal CNA procedure with anatomical approach will be performed with pre- and post procedural extracardiac vagal nerve stimulation in general anesthesia.

## Primary Outcomes

- **Number of Participants Who Had Freedom From Bradycardia Symptoms at 6 months** _(time frame: 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.
- **Number of Participants with Pacemaker Implantation at 6 months** _(time frame: 6 monhts)_ — Number of participants with PM implantation at 6 months

## Secondary Outcomes

- **Number of Events of Procedural Complications** _(time frame: 0-6 months)_
- **Number of Participants With Post-ablation Inducibility of Sinus Arrest and/or AV Block by Vagal Nerve Stimulation** _(time frame: 1 day (peri-procedural))_
- **Effect of CNA on Quality of Life Parameters Based on EQ-5D-5L Questionnaire** _(time frame: 0, 3, 6, 9, 12 months)_
- **Effect of CNA on Quality of Life Parameters Based on SF-36 Questionnaire** _(time frame: 0, 3, 6, 9, 12 months)_
- **Effect of CNA on Fatigue Based on Modified Fatigue Impact Scale (MFIS)** _(time frame: 0, 6, 12 months)_
- **Effect of CNA on Depression/Anxiety based on Modified Hospital Anxiety and Depression Scale (HADS-M)** _(time frame: 0, 6, 12 months)_
- **Effect of CNA on Sleep Disorders Based on Epworth Sleep Scale (ESS)** _(time frame: 0, 6, 12 months)_
- **Effect of CNA on Sleep Disorders Based on Athens Insomnia Scale-8 (AIS-8)** _(time frame: 0, 6, 12 months)_

## Locations (4)

- Center of Interventional Cardiology, Electrotherapy and Angiology G.V.M. Carint, Ostrowiec Świętokrzyski, 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, Poland — _RECRUITING_
- Department of Cardiology, Laboratory of Invasive Electrophysiology, 4th Military Teaching Hospital in Wroclaw, Wroclaw, Poland — _NOT_YET_RECRUITING_

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `sponsor.collaborators` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.center of interventional cardiology, electrotherapy and angiology g.v.m. carint|ostrowiec świętokrzyski||poland` — added _(2026-05-12)_
- `locations.medical center sabamed|rzeszów||poland` — added _(2026-05-12)_
- `locations.subcarpatian center for cardiovascular interventions, laboratory of electrophysiology, cardioneuroablation, ablation, arrhythmia and heart electrostimulation, g.v.m. carint|sanok||poland` — added _(2026-05-12)_
- `locations.department of cardiology, laboratory of invasive electrophysiology, 4th military teaching hospital in wroclaw|wroclaw||poland` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT05196126.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT05196126*  
*This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*