Comparison of Focal Cryoablation vs. Radiofrequency Cardioneuroablation for Bradyarrhythmias (CRYO-CNA vs RF)
Prospective Non-Randomized Comparison of Point-by-Point Cryoablation Using Freezor™ Xtra Versus Radiofrequency Ablation Using TactiFlex™ SE of Parasympathetic Ganglia (Cardioneuroablation) in Patients With Vagally-Mediated Bradyarrhythmias
Bradyarrhythmias are conditions where the heart beats too slowly, causing symptoms like dizziness, fainting, and fatigue. In some patients, these slow heart rhythms are caused by overactivity of the vagus nerve (the part of the nervous system that slows the heart down).
Cardioneuroablation (CNA) is a catheter-based procedure that targets and reduces the effect of these overactive nerves on the heart. It is an alternative to permanent pacemaker implantation, especially for younger patients.
Traditionally, CNA is performed using radiofrequency (RF) energy to create small burns in specific areas of the heart. This study investigates whether focal cryoablation (freezing technology using the Freezor™ Xtra catheter) is as safe and effective as standard RF ablation for CNA.
This is a prospective, non-randomized study. Participants will receive either RF ablation (N=30) or cryoablation (N=30). The study will evaluate the recurrence of slow heart rhythms and fainting episodes, as well as any complications, over 12 months of follow-up.
Panoramica dello studio
Stato
Intervento / Trattamento
Descrizione dettagliata
Background and Rationale
Cardioneuroablation is an emerging treatment for vagally-mediated bradyarrhythmias, including symptomatic sinus bradycardia, atrioventricular blocks, and vasovagal syncope with a cardioinhibitory component . The procedure targets ganglionated plexi located in the epicardial fat and myocardium, which contain parasympathetic nerve endings.
While radiofrequency (RF) energy is the standard modality for CNA, epicardial fat may limit RF lesion formation when fat thickness exceeds 3 mm. Cryoablation, by contrast, uniformly cools tissue without energy dissipation in fat, potentially offering more consistent ganglion ablation.
To date, no clinical study has compared focal cryoablation versus RF ablation specifically for cardioneuroablation.
Objectives
Primary: To compare the efficacy of focal cryoablation versus RF ablation for cardioneuroablation in preventing bradyarrhythmia recurrence.
Secondary: To compare the safety profile of both techniques, including periprocedural complications and inappropriate sinus tachycardia.
Study Design
This is a prospective, non-randomized, parallel-group study conducted at a single center (Cardiology Research Institute, Tomsk NRMC). Eligible patients aged 18-60 years with symptomatic vagally-mediated bradyarrhythmias (confirmed by positive atropine test and/or EP study) are assigned non-randomly to either:
Group 1 (RF-CNA, N=30): Radiofrequency ablation using TactiFlex™ SE catheter (Abbott), power 45W, target AI 45, with irrigation
Group 2 (Cryo-CNA, N=30): Focal cryoablation using Freezor™ Xtra 6mm catheter (Medtronic), target temperature -75°C, 240 seconds per application
Procedures
All procedures are performed under intravenous sedation. After establishing venous access, a 3D electroanatomical map of the right atrium is created using the EnSite™ X system with HD Grid mapping catheter. Ganglionated plexi are identified using spectral analysis (OTNF algorithm) and anatomical landmarks (RAGP and IRGP).
Ablation is applied at identified sites. Intraprocedural endpoints include:
Reduction of SNRT <1500 ms and cSNRT <525 ms
Wenckebach point ≥140 bpm
AV node ERP >300 ms
Absence of bradycardic response to phenylephrine (<10% heart rate reduction)
Follow-up
Patients are followed at 6 and 12 months post-procedure with clinical assessment, 12-lead ECG, and 24-hour Holter monitoring.
Statistical Considerations
The planned sample size is 60 patients (30 per group). Quantitative variables will be presented as mean±SD or median [Q1;Q3]. Paired t-test or Wilcoxon test will be used for pre-post comparisons. Between-group comparisons will use Mann-Whitney U test. Statistical significance set at p<0.05.
Tipo di studio
Iscrizione (Stimato)
Fase
- Non applicabile
Contatti e Sedi
Contatto studio
- Nome: Roman E Batalov, MD, PhD
- Numero di telefono: +73822558401
- Email: romancer@rambler.ru
Luoghi di studio
-
-
Tomsk Oblast
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Tomsk, Tomsk Oblast, Russia, 634012
- Reclutamento
- Cardiology Research Institute, Tomsk National Research Medical Center of the Russian Academy of Sciences
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Contatto:
- Stanislav Yu Usenkov, PhD
- Numero di telefono: +7 (3822) 55-84-01
- Email: sturus@rambler.ru
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-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Adulto
Accetta volontari sani
Descrizione
Inclusion Criteria:
- Age 18 to 60 years;
- Symptomatic bradycardia (sinus bradycardia or bradycardia due to atrioventricular block, including transient);
- Severe asymptomatic sinus bradycardia (heart rate less than 30 beats per minute);
- Transient second- or third-degree atrioventricular block;
- Persistent second-degree atrioventricular block;
- Rhythm pauses greater than 6 seconds;
- Recurrent syncope or presyncope with documented association with bradycardia (without trauma);
- Positive response to atropine (heart rate increase ≥25% from baseline or >90 beats per minute) OR positive response to exercise (heart rate increase ≥25% from baseline or >90 beats per minute, OR conversion of second- or third-degree atrioventricular block to first-degree block or complete normalization of atrioventricular conduction during sinus rhythm);
Exclusion Criteria:
- Chronic antiarrhythmic drug therapy (ongoing);
- Presence of implanted pacemaker, cardiac resynchronization therapy device, or implantable cardioverter-defibrillator;
- Bradyarrhythmia secondary to medications;
- Bradyarrhythmia secondary to electrolyte imbalance (hyperkalemia);
- Bradyarrhythmia secondary to hypothyroidism;
- Bradyarrhythmia secondary to obstructive sleep apnea syndrome;
- Absence of response to pharmacological denervation (no heart rate increase after atropine administration up to maximum dose of 0.2 mg/kg);
- Clinically significant coronary artery disease;
- Post-myocardial infarction cardiosclerosis;
- Hemodynamically significant congenital heart disease (including surgically corrected);
- Stable ventricular tachycardia in the setting of bradycardia;
- History of stroke or transient ischemic attack;
- Prior open-heart surgery;
- Prior catheter-based coronary artery intervention or percutaneous coronary intervention;
- Pregnancy or breastfeeding; Age less than 18 years Age greater than 60 years
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Non randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: CryoCNA
|
Focal cryoablation of right atrial ganglionated plexi using Freezor™ Xtra 6mm catheter (Medtronic) at -75°C for 240 seconds per application.
3-5 applications per GP zone.
Positioned by fluoroscopy and impedance-based tracking in EnSite™ X system.
|
|
Comparatore attivo: RF CNA
|
Radiofrequency ablation of right atrial ganglionated plexi using TactiFlex™ SE catheter (Abbott) with power up to 45W, temperature 50°C, target AI 45, with irrigation.
3-5 applications per GP zone.
Guided by EnSite™ X mapping system and spectral analysis (OTNF).
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Recurrence of Bradyarrhythmia or Syncope
Lasso di tempo: 12 months
|
Documented recurrence of symptomatic bradyarrhythmia (sinus bradycardia <40 bpm, pause >3 sec, AV block) or syncope confirmed by ECG or Holter
|
12 months
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Pericardial Effusion or Hemopericardium
Lasso di tempo: Periprocedural (7 days)
|
Pericardial effusion or hemopericardium requiring intervention, confirmed by echocardiography
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Periprocedural (7 days)
|
|
Inappropriate Sinus Tachycardia
Lasso di tempo: 12 months
|
Sustained sinus tachycardia >100 bpm without cause, requiring beta-blocker therapy
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12 months
|
|
Vascular Access Complications
Lasso di tempo: Periprocedural (7 days)
|
Hematoma, pseudoaneurysm, or AV fistula requiring treatment, confirmed by ultrasound
|
Periprocedural (7 days)
|
|
Change in Minimum Heart Rate
Lasso di tempo: Baseline to 6 months
|
Absolute change in minimum heart rate (bpm) on 24-hour Holter from baseline to 6 months
|
Baseline to 6 months
|
|
Change in Maximum Heart Rate
Lasso di tempo: Baseline to 6 months
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Absolute change in maximum heart rate (bpm) on 24-hour Holter from baseline to 6 months
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Baseline to 6 months
|
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Change in Electrophysiological Parameters
Lasso di tempo: Intraprocedural
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Normalization of cSNRT <525 ms, Wenckebach point ≥140 bpm, AV-ERP >300 ms
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Intraprocedural
|
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Change in Mean Heart Rate
Lasso di tempo: Baseline to 6 months
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Absolute change in minimum heart rate (bpm) on 24-hour Holter from baseline to 6 months
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Baseline to 6 months
|
Collaboratori e investigatori
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Stimato)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
- Malattia del sistema di conduzione cardiaca
- Manifestazioni neurologiche
- Malattie del sistema nervoso
- Malattia cardiovascolare
- Processi patologici
- Malattie cardiache
- Aritmie, cardiache
- Manifestazioni neurocomportamentali
- Arresto cardiaco
- Aritmia, seno
- Disautonomi primarie
- Malattie del sistema nervoso autonomo
- Intolleranza ortostatica
- Disturbi della coscienza
- Incoscienza
- Sincope
- Condizioni patologiche, segni e sintomi
- Segni e sintomi
- Blocco atrioventricolare
- Sindrome del seno malato
- Bradicardia
- Sincope, vasovagale
- Terapie
- Procedure chirurgiche, operative
- Tecniche di ablazione
- Ablazione della radiofrequenza
- Terapia a radiofrequenza
- Ablazione del catetere
Altri numeri di identificazione dello studio
- CRI-281/2
Piano per i dati dei singoli partecipanti (IPD)
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Informazioni su farmaci e dispositivi, documenti di studio
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