2018 ESC Guidelines for the diagnosis and management of syncope.
Michele Brignole, Angel Moya, Frederik J de Lange...
https://pubmed.ncbi.nlm.nih.gov/29562304Actively Recruiting
Phase Not Applicable
Age: 18Years - 75Years
All Genders
ID05774262
TELE-monitoring for Standard Pacemaker Implantation or Delayed Pacemaker Implantation After Autonomic/Electrophysiologic Evaluation and Cardioneuroablation for Management of Functional Atrioventricular Block - Randomized Controlled Study
Led by American Heart of Poland · Updated on 2024-03-18
300
Participants Needed
2
Research Sites
17 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating two different approaches to treat functional Atrio-Ventricular Block (AVB), a heart condition affecting electrical conduction. This trial compares the usual elective pacemaker (PM) implantation recommended by guidelines with a newer method involving cardiovascular autonomic tests (CAT), electrophysiologic assessment (EPS), and a procedure called cardioneuroablation (CNA). The study aims to see if CNA can safely and effectively treat AVB without the need for a permanent pacemaker, validating current recommendations and exploring an alternative treatment option. The trial will include at least 100 participants aged 18 to 75 with AVB and a positive atropine test. Participants will be randomly assigned to receive either early pacemaker implantation (Group A) or undergo CAT/EPS followed by CNA with possible delayed pacemaker implantation if needed (Group B). Those opting out of randomization enter a registry with personalized treatment choices. Group A will receive pacemakers with telemonitoring, while Group B will get implantable loop recorders and undergo CNA under general anesthesia. If CNA is unsuccessful, pacemaker implantation may follow. Participants will be involved for at least 12 months, undergoing regular check-ups at baseline, 3, 6, and 12 months. Assessments include ECG telemonitoring, quality of life and symptom questionnaires, and cardiovascular autonomic tests with telemedicine support. Safety will be closely monitored monthly, focusing on major cardiovascular events. The study uses telemonitoring devices and provides 24/7 contact with specialized medical staff. Data on symptoms, fatigue, depression, and sleep will also be collected to evaluate treatment effects comprehensively.
CONDITIONS
Brief Title
Pacemaker Implantation Versus Cardioneuroablation for Functional Atrioventricular Block
Who Can Participate
Age: 18Years - 75Years
All Genders
Eligibility Criteria
You may qualify if you...
- Written informed consent to participate in the study
- Age between 18 and 75 years
- Indication for elective pacemaker implantation according to ESC guidelines for isolated paroxysmal, persistent, or reflex atrioventricular block
- Specific AVB types including symptomatic first degree AVB (over 300 msec), symptomatic Mobitz type I second degree AVB, 2:1 AVB not during sleep, advanced Mobitz II or complete AVB, advanced AVB during atrial fibrillation not during sleep
- Reflex syncope in patients over 40 years with documented pauses within AVB mechanism either symptomatic or asymptomatic
You will not qualify if you...
- Previously implanted pacemaker, ICD, or CRT device
- Sinus node dysfunction requiring pacemaker implantation
- Planned ablation of the atrioventricular junction
- Severe prolonged bradycardia needing intravenous drugs or temporary pacing
- Recent cardiac surgery
- Acute myocardial infarction or heart failure unrelated to bradycardia
- Recent valvular intervention or ablation
- Acute infection or other diseases contraindicating pacemaker implantation or procedures
- Pregnancy, nursing, or planned pregnancy within 12 months
- Decompensated chronic diseases such as endocrine or electrolyte disorders
- Advanced cardiomyopathies or ventricular arrhythmias requiring ICD
- Persistent right or left bundle branch block
- Musculoskeletal diseases requiring pacemaker
- Contraindications to study procedures
- Mental illness or cognitive impairment preventing independent participation including telemedicine use
- Any other abnormalities considered unsafe by the Principal Investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and randomization visit
Treatment
Duration - Up to 12 months
Participants receive either elective pacemaker implantation or cardioneuroablation with implantable loop recorder monitoring, depending on their assigned group. Participants undergo cardiovascular autonomic testing, electrophysiological studies, and extracardiac vagal nerve stimulation as part of treatment and evaluation procedures. Those in the cardioneuroablation group may receive a second ablation or pacemaker implantation if needed.
Regular telemedicine contacts and periodic in-person follow-up visits during 12 months
Follow-up
Duration - 12 months after treatment start
Participants are monitored for safety and efficacy outcomes including major adverse cardiovascular events and quality of life assessments through telemedicine and in-person visits.
Visits at 0, 3, 6, and 12 months including assessments and questionnaires
Trial Site Locations
Total: 2 locations
1
American Heart of Poland
Dąbrowa Górnicza, Poland, 41-300
Actively Recruiting
2
American Heart of Poland
Mielec, Poland, 39-300
Actively Recruiting
Loading map...
Research Team
S
Sebastian M Stec, MD, PhD
E
Edyta Stodolkiewicz-Nowarska, MD PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here
Published Research Related To This Trial
2021 ESC Guidelines on cardiac pacing and cardiac resynchronization therapy.
Michael Glikson, Jens Cosedis Nielsen, Mads Brix Kronborg...
https://pubmed.ncbi.nlm.nih.gov/344554302017 ACC/AHA/HRS Guideline for the Evaluation and Management of Patients With Syncope: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines and the Heart Rhythm Society.
Win-Kuang Shen, Robert S Sheldon, David G Benditt...
https://pubmed.ncbi.nlm.nih.gov/28280231[Radiofrequency ablation and cardioneuroablation for AVNRT and atrioventricular block].
Monika Klank-Szafran, Sebastian Stec, Janusz Sledź...
https://pubmed.ncbi.nlm.nih.gov/20806214Cardioneuroablation in the treatment of neurally mediated reflex syncope: a review of the current literature.
Tolga Aksu, Tümer Erdem Güler, Serdar Bozyel...
https://pubmed.ncbi.nlm.nih.gov/28106018Catheter Ablation of Atrioventricular Block: From Diagnosis to Selection of Proper Treatment.
Erkan Baysal, Tumer Erdem Guler, Rakesh Gopinathannair...
https://pubmed.ncbi.nlm.nih.gov/34317058Cardioneuroablation for Treatment of Atrioventricular Block.
Tolga Aksu, Rakesh Gopinathannair, Serdar Bozyel...
https://pubmed.ncbi.nlm.nih.gov/34465122Ultrasound-guided imaging for vagus nerve stimulation to facilitate cardioneuroablation for the treatment of functional advanced atrioventricular block.
Antoni Wileczek, Anna Polewczyk, Maciej Kluk...
https://pubmed.ncbi.nlm.nih.gov/34186197Safety and efficacy of His bundle pacing validated by extracardiac vagal nerve stimulation (HIS-STORY).
Krystian Josiak, Sebastian Stec, Dorota Zyśko...
https://pubmed.ncbi.nlm.nih.gov/35703044Cardioneuroablation for the effective treatment of recurrent vasovagal syncope to restore driving abilities.
Agnieszka Reichert, Antoni Wileczek, Sebastian Stec
https://pubmed.ncbi.nlm.nih.gov/35946179