2021 ESC Guidelines on cardiac pacing and cardiac resynchronization therapy.
Michael Glikson, Jens Cosedis Nielsen, Mads Brix Kronborg...
https://pubmed.ncbi.nlm.nih.gov/34455430Actively Recruiting
Phase Not Applicable
Age: 18Years - 65Years
All Genders
ID05896592
Comparison of Cardioneuroablation and Permanent Pacing in Patients With Implanted Pacemakers for Symptomatic Bradycardia
Led by 4th Military Clinical Hospital with Polyclinic, Poland · Updated on 2024-01-03
99
Participants Needed
2
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating cardioneuroablation (CNA) as an alternative treatment to permanent pacemaker (PM) therapy for patients with symptomatic bradycardia caused by sinus node dysfunction (SND) or atrioventricular block (AVB). The study aims to assess the safety and effectiveness of CNA in allowing patients to discontinue or optimize PM therapy. It also seeks to develop a diagnostic method for selecting suitable patients for CNA and PM therapy discontinuation. Participants are randomly assigned to one of three groups: Group 1 receives invasive electrophysiology study (EPS), extracardiac vagal stimulation (ECVS), CNA, continued PM therapy, and implantable loop recorder (ILR) implantation; Group 2 undergoes EPS, ECVS, continued PM therapy, and ILR implantation without initial CNA but with delayed CNA later in the study; Group 3 is observed without intervention. The study includes follow-up hospitalizations and visits involving repeated EPS, ECVS, CNA if needed, PM reprogramming, and non-invasive assessments of CNA effectiveness and bradycardia symptoms. Throughout the 18-month study, participants undergo regular evaluations including ECG, PM checks, laboratory tests, 24-hour Holter ECG, ILR monitoring, and symptom assessments. Researchers monitor pacing percentages, bradycardia symptoms, and possible adverse effects. Patients with minimal or no pacing needs may have their pacemakers set to pacing-off modes. The study also collects blood samples for future research and includes detailed follow-up visits every 3 months for assessment and potential qualification for pacemaker therapy discontinuation or lead extraction.
CONDITIONS
Brief Title
Comparison of the Efficacy and Safety of Cardioneuroablation to Permanent Pacing in Patients With an Implanted Pacemaker for Symptomatic Bradycardia.
Who Can Participate
Age: 18Years - 65Years
All Genders
Eligibility Criteria
You may qualify if you...
- Patients who had pacemaker implantation before age 50 due to sinus node or atrioventricular node dysfunction
- Positive response to atropine test
- Age between 18 and 65 years
- Signed informed consent to participate in the study
You will not qualify if you...
- Heart rate less than 30 beats per minute
- Fainting after pacemaker therapy started
- Persistent and sustained atrial fibrillation
- History of myocarditis
- History of myocardial infarction
- History of cardiac surgery
- History of ablation procedures
- Congenital heart defects
- Congenital atrioventricular block
- Neuromuscular or neurodegenerative diseases
- Need to upgrade pacemaker to ICD or CRT-D
- Pregnancy
- Kidney failure with GFR less than 30 ml/min/1.73m2
- Age below 18 or above 65 years
- HAS-BLED score 3 or higher points
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit (in-person)
Treatment
Duration - Up to 4 months from randomization
Participants undergo assigned procedures depending on their group: Group 1 receives electrophysiological studies, extracardiac vagal stimulation, cardioneuroablation, and implantable loop recorder implantation; Group 2 receives electrophysiological studies, extracardiac vagal stimulation, implantable loop recorder implantation, and delayed cardioneuroablation; Group 3 is observed without invasive procedures. Pacemaker therapy continues and is adjusted throughout this period.
Hospitalizations and procedures occur at 1 month and 4 months after randomization
Monitoring
Duration - From 1 month up to 18 months after randomization
Participants are monitored with regular assessments including pacemaker checks, ECG, non-invasive electrophysiological studies, 24-hour Holter ECG monitoring, implantable loop recorder checks, and symptom evaluation to assess treatment efficacy and adjust pacemaker settings as needed.
Regular visits at 1, 3, 4, 6, 9, 12, 15, and 18 months after randomization
Follow-up and Study Completion
Duration - At 18 months after randomization
At 18 months, participants undergo final assessments including atropine test, comprehensive pacemaker evaluation, and symptom review. Participants without bradycardia symptoms may be qualified to discontinue permanent pacing therapy and possibly undergo transvenous lead extraction.
1 final visit (in-person)
Trial Site Locations
Total: 2 locations
1
Mazowiecki Specialist Hospital
Radom, Masovian Voivodeship, Poland, 26-617
Actively Recruiting
2
Medical University of Silesia
Katowice, Silesian Voivodeship, Poland, 40-055
Actively Recruiting
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Research Team
P
Przemyslaw Skoczynski, PhD
B
Bruno Hrymniak, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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Mina K Chung, Angela Fagerlin, Paul J Wang...
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Jose C Pachon, Enrique I Pachon, Juan C Pachon...
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Łukasz Tułecki, Anna Polewczyk, Wojciech Jacheć...
https://pubmed.ncbi.nlm.nih.gov/34639716The effect of centre volume and procedure location on major complications and mortality from transvenous lead extraction: an ESC EHRA EORP European Lead Extraction ConTRolled ELECTRa registry subanalysis.
Baldeep S Sidhu, Justin Gould, Catey Bunce...
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