POLish Registry of CArdioneuroablation and CArdioneuromodulation (POL-CA)

SABAMED Medical Center Ltd.

Status: Enrolling

Conditions: Inappropriate Sinus Tachycardia Syndrome IST; Raynaud Phenomena; Cardioinhibitory Carotid Sinus Syndrome CSS; Microvascular Angina; Ventricular Arrythmia; Symptomatic Sinus Bradycardia SB or Atrioventricular Block AV; Vasospastic Angina; Vasovagal Syndrome VVS; Autonomic Diseases; Postural Orthostatic Tachycardia Syndrome POTS; Orthostatic Hypotension; Autonomic Dysfunction

Treatments: Behavioral: Hybrid Cardiac Rehabilitation Program; Procedure: Cardiac sympathetic denervation; Device: Transcutaneous Vagus Nerve Stimulation (tVNS); Procedure: SN sparing hybrid ablation; Procedure: cardioneuroablation

Study type: Observational

Funder types: NETWORK

Identifiers

NCT07196397

51/2024/В

Details and patient eligibility

About

The multicentre observational study POL-CA involves a wide spectrum of patients with a history of syncopy. The study recruits patients with diagnosed vasovagal syndrome, cardioinhibitory carotid sinus syndrome, symptomatic sinus bradycardia or atrioventricular block, postural orthostatic tachycardia syndrome, orthostatic hypotension, and inappropriate sinus tachycardia syndrome. This is an observational, controlled study with retrospective, clinical data analysis of previously treated patients and the analysis of syncopal patients prospectively recruited into the study. The aim of the POL-CA registry is to create a platform for physicians to record treatment data for patients undergoing procedures that affect innervation or modify cardiovascular reflexes (cardioneuroablation, cardioneuromodulation) in order to provide a multicentre summary of population characteristics and treatment outcomes based on a standardized POL-CA questionnaire and methodology for various arrhythmias.

Full description

The study aims to include a group of at least 1,000 individuals, taking into account subgroups of patients with rare diseases involving fewer than 50 individuals (e.g., carotid sinus hypersensitivity or familial sinus bradycardia). Participants will be divided into three age groups: 18-40 years, 41-60 years, and over 60 years. These individuals will undergo procedures affecting innervation or modifying cardiovascular reflexes (cardioneuroablation or neuromodulation) due to ineffective pharmacological treatment or training methods. This group will also include patients who, according to guidelines, qualify for pacemaker implantation but declined the procedure.

The clinical trial protocol specifies inclusion and exclusion criteria. The protocol outlines the collection of various data, including traditional medical history (including contact information) and data related to the interventional treatment performed (including assessment of treatment efficacy and the occurrence of both perioperative and long-term complications). Additionally, the protocol includes the use of scales and questionnaires to evaluate patient symptoms and well-being, as well as an analysis of standard and non-standard verbal and non-verbal behaviors of patients. Scales and questionnaires used to assess patient symptoms and well-being: EQ-5D, SF-36, VASIS for bradycardia symptoms (daytime, before sleep, nighttime, and morning), and MALMO scoring test.

Patients will also routinely undergo physical performance evaluations (assessment using the Borg scale, HRR analysis, correlation of heart rate values during exercise before and after the procedure, 6MWT walk tests, and analysis of tele-rehabilitation outcomes).

Patient follow-up will be conducted at 1, 6, and 12 months post-procedure and then annually from 2024 to 2030, with ECG evaluations. The primary endpoint of the study is the spontaneous recurrence of symptoms that were present before the procedure affecting innervation and/or cardiovascular reflexes.

Enrolment in the POL-CA registry does not involve performing any additional invasive medical procedures on the patients.

The Single POL-CA Registry for a specific treatment technique will be managed by an appointed project leader. The project leader will be responsible for preparing a literature review, inclusion criteria, and clinical and electrophysiological characteristics of the given treatment technique. The project leader either becomes the first author of the publication or designates one. Physicians' participation in the project will be voluntary, with acceptance of audits or data verification at local centres. Patient personal data will only be accessible to the local investigator and will remain protected. The order of authorship for the publication will be determined based on the contributions of the other project participants (e.g., number of patients, manuscript preparation, data analysis).

The POL-CA online platform will include a standardized data creation panel for the project leader and the study's website. Data collection will comply with standard encryption, protection procedures, and the requirements of bioethics and scientific committees.

Enrollment: 1,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age ≥ 18 years

• Diagnosis of at least one of the following conditions:

  • Inappropriate sinus tachycardia (IST)
  • Postural orthostatic tachycardia syndrome (POTS)
  • Vasovagal syncope (VVS)
  • Cardioinhibitory carotid sinus syndrome (CSS)
  • Symptomatic sinus bradycardia or functional AV block
  • Orthostatic hypotension (OH)

• History of recurrent autonomic symptoms (e.g., syncope, bradycardia, palpitations, orthostatic intolerance)

• Undergoing or previously underwent interventional treatment affecting cardiac autonomic innervation (e.g., cardioneuroablation, SN-sparing ablation, cardiac sympathetic denervation)

• Provided written informed consent (for prospective arm)

Exclusion criteria

• Structural heart disease requiring surgical intervention
• Permanent pacemaker or ICD implanted prior to enrollment
• Inability to complete follow-up assessments or questionnaires
• Severe psychiatric comorbidities impairing participation
• Participation in another interventional clinical trial

Trial design

1,000 participants in 4 patient groups

vagally mediated bradycardia

Description:

This cohort includes patients with vagally mediated bradycardia, including cardioinhibitory vasovagal syncope, carotid sinus syndrome, or functional sinus node dysfunction related to excessive parasympathetic activation. Patients are referred for interventional treatment due to recurrent syncope or symptomatic bradycardia refractory to conservative management. Interventions include cardioneuroablation or autonomic modulation procedures aimed at reducing vagal influence on the sinus and atrioventricular nodes while preserving physiological autonomic balance. Diagnosis is confirmed based on tilt-table testing, ECG documentation, and symptom correlation.

Treatment:

Procedure: cardioneuroablation

Behavioral: Hybrid Cardiac Rehabilitation Program

IST/POTS

Description:

This cohort includes patients diagnosed with inappropriate sinus tachycardia (IST) or postural orthostatic tachycardia syndrome (POTS) who are undergoing interventional treatment due to insufficient response to pharmacological or behavioral therapy. Interventions include sinus node-sparing thoracoscopic ablation aimed at improving symptoms and quality of life. Autonomic dysfunction is confirmed based on standardized testing, and the interventions target neural pathways involved in excessive sympathetic or inadequate parasympathetic control of heart rate and vascular tone.

Treatment:

Procedure: SN sparing hybrid ablation

Device: Transcutaneous Vagus Nerve Stimulation (tVNS)

Behavioral: Hybrid Cardiac Rehabilitation Program

Cardiac sympathetic denervation

Description:

Patients with clinical indications for stand-alone or concomittant, hybrid cardiac sympathetic denervation. This cohort includes patients with arrhythmias driven by excessive sympathetic activation, such as congenital long QT syndrome (LQTS), catecholaminergic polymorphic ventricular tachycardia (CPVT), and refractory ventricular tachyarrhythmias. Patients are referred for cardiac sympathetic denervation (CSD) due to high arrhythmic burden despite optimal pharmacologic treatment or recurrent implantable cardioverter-defibrillator (ICD) shocks. CSD is performed via thoracoscopic access and involves ablation or removal of the stellate ganglion and thoracic sympathetic chain (typically T2-T4). The goal is to reduce sympathetic drive, stabilize cardiac electrophysiology, and prevent life-threatening arrhythmias.

Treatment:

Procedure: Cardiac sympathetic denervation

Behavioral: Hybrid Cardiac Rehabilitation Program

other rare subgroups and neuromodulation intervention

Description:

This cohort includes patients with rare autonomic or electrophysiological syndromes undergoing neuromodulatory interventions as part of individualized treatment strategies. Interventions may include transcutaneous vagus nerve stimulation (tVNS), structured cardiac rehabilitation programs with autonomic modulation components, and other non-invasive or minimally invasive techniques aimed at improving autonomic balance and symptom burden. This group is characterized by heterogeneous diagnoses, including overlapping or atypical forms of autonomic dysfunction, and is managed with a personalized, multidisciplinary approach integrating physiologic monitoring, rehabilitation, and neuromodulation.

Treatment:

Procedure: cardioneuroablation

Procedure: SN sparing hybrid ablation

Device: Transcutaneous Vagus Nerve Stimulation (tVNS)

Procedure: Cardiac sympathetic denervation

Behavioral: Hybrid Cardiac Rehabilitation Program