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Permanent Pacemaker Implantation or Cardioneuroablation in Sinus Node Dysfunction

NCT05196126 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2023-03-07

No results posted yet for this study

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

Interventions

PROCEDURE

Permament pacemaker implantation

PM implantation

PROCEDURE

Cardioneuroablation

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

Sponsors & Collaborators

  • KCRI

    collaborator OTHER

  • Stec, Sebastian, MD, PhD, FESC

    lead OTHER

Principal Investigators

  • Sebastian Stec, MD, PhD · Medical Center SABAMED Medicans

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-06-01
Primary Completion
2024-05-31
Completion
2024-06-30

Countries

  • Poland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05196126 on ClinicalTrials.gov