Bilateral Cardiac Sympathetic Denervation for Refractory Multifocal Premature Ventricular Contractions in Patients With Nonischemic Cardiomyopathy.
Adnan Ahmed, Rishi Charate, Danish Bawa...
https://pubmed.ncbi.nlm.nih.gov/37943190Actively Recruiting
Age: 18Years +
All Genders
ID07196397
POLish Registry of Cardioneuroablation and Cardioneuromodulation: Multicenter Observational Study of Neuromodulatory Procedures in Cardiovascular Autonomic Dysfunction Syndromes
Led by SABAMED Medical Center Ltd. · Updated on 2025-09-29
1000
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research investigates a wide range of patients with histories of fainting (syncope) and autonomic dysfunction syndromes such as vasovagal syndrome, cardioinhibitory carotid sinus syndrome, symptomatic sinus bradycardia or atrioventricular block, postural orthostatic tachycardia syndrome, orthostatic hypotension, and inappropriate sinus tachycardia syndrome. The study aims to create a comprehensive registry to analyze treatment outcomes and population characteristics by collecting standardized data from patients who undergo neuromodulatory procedures affecting heart innervation and cardiovascular reflexes. These procedures are studied in patients who have not responded to medications or training, including those who declined pacemaker implantation. Participants will be grouped by age and condition and may have undergone procedures like cardioneuroablation, sinus node-sparing ablation, cardiac sympathetic denervation, or neuromodulatory therapies such as transcutaneous vagus nerve stimulation and hybrid cardiac rehabilitation. These interventions aim to modify autonomic nervous system inputs to improve symptoms related to abnormal heart rate and rhythm. The study collects detailed clinical and treatment data, including patient symptoms, well-being, and physical performance measures. Participants will be followed up at 1, 6, and 12 months after the procedure and then annually through 2030, with evaluations including ECGs, symptom questionnaires, and physical tests like the 6-minute walk test. The primary measurement is the recurrence of symptoms present before the neuromodulatory treatment. Data security and confidentiality are maintained throughout the study, and no additional invasive procedures are performed solely for the registry participation.
CONDITIONS
Brief Title
POLish Registry of CArdioneuroablation and CArdioneuromodulation
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Diagnosis of at least one of the following: inappropriate sinus tachycardia, postural orthostatic tachycardia syndrome, vasovagal syncope, cardioinhibitory carotid sinus syndrome, symptomatic sinus bradycardia or functional atrioventricular block, orthostatic hypotension
- History of recurrent autonomic symptoms such as syncope, bradycardia, palpitations, or orthostatic intolerance
- Undergoing or previously underwent interventional treatment affecting cardiac autonomic innervation, including cardioneuroablation, sinus node-sparing ablation, or cardiac sympathetic denervation
- Provided written informed consent for participation (for prospective arm)
You will not qualify if you...
- Structural heart disease requiring surgical intervention
- Permanent pacemaker or implantable cardioverter-defibrillator (ICD) implanted prior to enrollment
- Unable to complete follow-up assessments or questionnaires
- Severe psychiatric conditions impairing study participation
- Participation in another interventional clinical trial
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 visit (in-person)
Diagnostic Evaluation
Duration - Up to 1 month
Participants undergo diagnostic assessments including tilt-table testing, ECG documentation, and symptom correlation to confirm autonomic dysfunction and eligibility for interventional treatment.
1 to 2 visits depending on diagnostic procedures
Interventional Procedure
Duration - Procedure and immediate recovery period
Participants undergo neuromodulatory procedures such as cardioneuroablation, sinus node-sparing hybrid ablation, cardiac sympathetic denervation, or transcutaneous vagus nerve stimulation tailored to their autonomic profile.
1 procedural visit (in-person)
Hybrid Cardiac Rehabilitation Program
Duration - Variable duration based on rehabilitation protocol
Participants engage in a two-phase rehabilitation program combining supervised inpatient exercise, respiratory training, psychological support, and home-based telerehabilitation to restore functional capacity and improve autonomic balance.
Multiple visits including inpatient and remote monitoring sessions
Follow-up
Duration - Up to 7 years
Participants are followed up at 1, 6, and 12 months post-procedure and then annually through 2030 to assess symptom recurrence and treatment efficacy, including ECG evaluations.
Visits at 1, 6, and 12 months post-procedure and annual visits thereafter
Trial Site Locations
Total: 1 location
1
SabaMed
Rzeszów, Poland
Actively Recruiting
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Research Team
S
Sebastian Stec, Prof., MD, PhD
M
Marta Kornaszewska, MD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
4
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Published Research Related To This Trial
Double trouble: Hybrid management of inappropriate sinus tachycardia and sinus bradycardia in the era of cardioneuromodulation.
Sebastian Stec, Rafal Kuteszko, Agnieszka Sulik...
https://pubmed.ncbi.nlm.nih.gov/41333861Implementation of a Hybrid Cardiac Rehabilitation and Symptom Scoring System in Patients with Inappropriate or Postural Sinus Tachycardia Referred for Sinus Node Sparing Hybrid Ablation.
Marta Kornaszewska, Aleksandra Wilczek-Banc, Anna Ratajska...
https://pubmed.ncbi.nlm.nih.gov/40869705EP-Heart Team approach with sinus node sparing ablation for complex inappropriate sinus tachycardia and postural orthostatic tachycardia syndrome: A first experience in Central Europe.
Sebastian Stec, Piotr Suwalski, Carlo de Asmundis...
https://pubmed.ncbi.nlm.nih.gov/39743902Hybrid epicardial and endocardial sinus node-sparing ablation therapy for inappropriate sinus tachycardia: Rationale and design of the multicenter HEAL-IST IDE trial.
Carlo de Asmundis, Luigi Pannone, Dhanunjaya Lakkireddy...
https://pubmed.ncbi.nlm.nih.gov/37124558Sinus Node Sparing Hybrid Thoracoscopic Ablation Outcomes in Patients with Inappropriate Sinus Tachycardia (SUSRUTA-IST) Registry.
Dhanunjaya Lakkireddy, Jalaj Garg, Carlo DeAsmundis...
https://pubmed.ncbi.nlm.nih.gov/34339847Cardioneuroablation for the treatment of reflex syncope and functional bradyarrhythmias: A Scientific Statement of the European Heart Rhythm Association (EHRA) of the ESC, the Heart Rhythm Society (HRS), the Asia Pacific Heart Rhythm Society (APHRS) and the Latin American Heart Rhythm Society (LAHRS).
Tolga Aksu, Michele Brignole, Leonardo Calo...
https://pubmed.ncbi.nlm.nih.gov/39082698Cardioneuroablation for reflex asystolic syncope: Mid-term safety, efficacy, and patient's acceptance.
Piotr Kulakowski, Jakub Baran, Agnieszka Sikorska...
https://pubmed.ncbi.nlm.nih.gov/38036236Cardioneuroablation for Reflex Syncope: Efficacy and Effects on Autonomic Cardiac Regulation-A Prospective Randomized Trial.
Roman Piotrowski, Jakub Baran, Agnieszka Sikorska...
https://pubmed.ncbi.nlm.nih.gov/36114133"Cardioneuroablation"--new treatment for neurocardiogenic syncope, functional AV block and sinus dysfunction using catheter RF-ablation.
Jose C Pachon, Enrique I Pachon, Juan C Pachon...
https://pubmed.ncbi.nlm.nih.gov/15670960