Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
Recruitment Status
COMPLETED
Clinical Phase
NA
Total Enrollment
48 participants
Study Classification
INTERVENTIONAL
Study Start Date
2018-11-01
Study Completion Date
2022-02-15
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Aim. To assess the effects of cardioneuroablation (CNA) on cardiac autonomic regulation and syncope recurrences in patients with vasovagal syncope (VVS), and to compare this novel approach with standard non-pharmacological treatment.
Measurements.
1. Before CNA:
1. Detailed history taking and assessment of eligibility
2. Baseline 12-lead ECG for heart rate assessment, morphology and duration of the P wave and PR interval
3. 24-hour Holter ECG for heart rhythm (mean, minimal, maximal, pauses) and heart rate variability (HRV) assessment
4. Passive tilt test (70 degrees, 45 minutes) to fulfill inclusion criterion and to assess baseline autonomic parameters such as HRV and baroreflex sensitivity (BRS) using sequential method. These parameters will be calculated from 5 min recordings before and after orthostatic stress (tilt).
5. Atropine test - positive response to intravenous atropine in a dose of 2 mg defined as at least 30% increase in sinus rate compared with baseline value
6. Assessment of quality of life using the SF-36 questionnaire
7. Implantable Loop Recorder (ILR) implantation 2-3 days before CNA
2. During CNA:
1. Heart rate before and immediately after CNA
2. Episodes of bradycardia (sinus arrest or atrio-ventricular block) during application of RF to GP.
3. Standard electrophysiological parameters (sinus node recovery time, corrected sinus recovery time, refractory atrio-ventricular node, atrio-ventricular conduction - Wenckebach point, A-H and H-V intervals) will be assessed before an immediately after CNA
4. Atropine test (2 mg) will be repeated immediately after CNA.
3. After CNA:
1. 1-2 days after CNA standard ECG
2. Follow-up: 3, 12 and 24 months after CNA assessment of symptoms, 12 lead standard ECG, control of ILR, 24-hour Holter ECG, tilt test and atropine test will be performed. Additionally, quality of life will be assessed using SF-36 questionnaire
Anticipated results.
1. CNA performed with technique used in the present study is effective in \> 90% of patients.
2. CNA-induced changes in analysed ECG and autonomic parameters predict CNA efficacy
Measurements.
1. Before CNA:
1. Detailed history taking and assessment of eligibility
2. Baseline 12-lead ECG for heart rate assessment, morphology and duration of the P wave and PR interval
3. 24-hour Holter ECG for heart rhythm (mean, minimal, maximal, pauses) and heart rate variability (HRV) assessment
4. Passive tilt test (70 degrees, 45 minutes) to fulfill inclusion criterion and to assess baseline autonomic parameters such as HRV and baroreflex sensitivity (BRS) using sequential method. These parameters will be calculated from 5 min recordings before and after orthostatic stress (tilt).
5. Atropine test - positive response to intravenous atropine in a dose of 2 mg defined as at least 30% increase in sinus rate compared with baseline value
6. Assessment of quality of life using the SF-36 questionnaire
7. Implantable Loop Recorder (ILR) implantation 2-3 days before CNA
2. During CNA:
1. Heart rate before and immediately after CNA
2. Episodes of bradycardia (sinus arrest or atrio-ventricular block) during application of RF to GP.
3. Standard electrophysiological parameters (sinus node recovery time, corrected sinus recovery time, refractory atrio-ventricular node, atrio-ventricular conduction - Wenckebach point, A-H and H-V intervals) will be assessed before an immediately after CNA
4. Atropine test (2 mg) will be repeated immediately after CNA.
3. After CNA:
1. 1-2 days after CNA standard ECG
2. Follow-up: 3, 12 and 24 months after CNA assessment of symptoms, 12 lead standard ECG, control of ILR, 24-hour Holter ECG, tilt test and atropine test will be performed. Additionally, quality of life will be assessed using SF-36 questionnaire
Anticipated results.
1. CNA performed with technique used in the present study is effective in \> 90% of patients.
2. CNA-induced changes in analysed ECG and autonomic parameters predict CNA efficacy
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Cardioneuroablation for Reflex Syncope and Exercise Capacity
NCT06440291
Syncope, Vasovagal
RECRUITING
NA
Assessment of the Durability of Cardioneuroablation Using Physiological Indices of Heart Rate Reactivity
NCT06697145
Syncope, Vasovagal, Neurally-Mediated
COMPLETED
NA
Cardioneuroablation and Ventricular Proarrhythmia
NCT06458140
Syncope, Vasovagal
RECRUITING
NA
Cardioinhibitory Reflex Syncope. Permanent Pacemaker Therapy or Cardioneuroablation?
NCT05855603
Reflex Syncope
RECRUITING
NA
Cardiac Autonomic Denervation for Cardio-inhibitory Syncope
NCT05572034
Bradycardia; Syncope
Syncope, Vasovagal
UNKNOWN
NA
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Introduction.
Reflex syncope due to vasovagal reaction is the most frequent cause of transient loss of consciousness (TLOC) in general population. \[1-4\] It markedly decreases quality of life and may lead to injury. \[5, 6\] The mechanism of vasovagal syncope (VVS) is complex. One of the most important mechanisms is enhanced parasympathetic activity triggered by abnormal mechanoreceptor reflex and other mechanisms. This leads to prolonged asystole and/or vasodilatation, resulting in syncope. \[7\] Treatment of VVS remains a challenge. Non-pharmacological treatment such as fluid and salt intake, avoiding situations triggering syncope or tilt training is not effective in a significant proportion of subjects with syncope. Pharmacotherapy is even less effective. Syncope recurs in 25-65% of patients. Alternative therapy, especially in patients with prolonged asystole, is pacemaker implantation, recommended by the guidelines in patients aged \> 40 years with documented spontaneous cardioinhibitory VVS and severe symptoms. However, permanent pacing occurs ineffective in at least 25% of patients. In addition, VVS occurs predominantly in young persons in whom permanent pacing should be avoided as much as possible. \[8-13\] Thus, the need for new treatment options in VVS is clear.
Ablation for atrial fibrillation (AF) has been successfully performed for almost two decades. Apart from pulmonary vein isolation which is a corner stone of AF ablation, autonomic control of the heart is modified by ablation of ganglionated plexi (GP). It has been well documented that in some patients GP ablation increases the success rate of ablation, especially in patients with vagally-mediated AF. Thus, the technique of GP ablation, mainly using the radio-frequency energy, is well established and safe.
Based on data coming from GP ablation during AF procedures, this method has been recently proposed for patients with VVS. The postulated beneficial mechanisms of GP ablation in VVS are attenuation of parasympathetic activity, leading to elimination or reduction reflex asystole and bradycardia. To date, a few case series consisting of up to 70 patients demonstrated very promising results. \[15-18\]. However, this experience is limited to a few centers. Also, the optimal methodology of the procedure, called cardioneuroablation (CNA) or cardioneuromodulation, is not known. There is no consensus yet as to how many GP's, in both atria or only in the right atrium, in which order and to what extent should be ablated. Moreover, mechanisms responsible for beneficial effects of CNA as well as methods assessing it's efficacy are not clear.
Aim. To assess the effects of CNA on cardiac autonomic regulation and syncope recurrences in patients with VVS, and to compare this novel approach with standard non-pharmacological treatment.
Hypothesis. CNA using GP ablation causes significant changes in autonomic control of the heart, predominantly parasympathetic withdrawal, which is associated with long-term efficacy of the procedure, and is significantly more effective than standard non-pharmacological therapy.
Methods. This is an open-label, randomized, controlled, prospective study.
Study group. Forty consecutive patients with recurrent cardioinhibitory or mixed VVS will be included between August 2018 and July 2021.
The patients will be randomized into 2 groups:
1. Treatment arm (n=20): CNA
2. Control arm (n=20): standard non-pharmacological treatment The patients from the control arm will be allowed to cross over to the CNA group if syncopal episode occurs despite adherence to the non-pharmacological recommendations.
The number of 40 patients will be enough to demonstrate superiority of CNA over standard approach, assuming that the effectiveness of CNA will be over 90%, and the effectiveness of the standard non-pharmacological treatment will be 50%.
Inclusion criteria:
1. At least one documented spontaneous VVS during preceding 12 months or one syncope in history leading to injury and minimum 2 presyncopal events during preceding 12 months, refractory to all recommended types of standard treatment.
2. In case of lack of ECG documentation during spontaneous syncope and history suggesting reflex syncope, at least 3 seconds of asystole due to sinus arrest or atrio-ventricular block with syncope or bradycardia \<40 beats per minute with syncope or presyncope during baseline tilt test
3. Sinus rhythm during ECG and tilt test
4. Significantly decreased quality of life due to syncope
5. Positive response to atropine test
6. Obtained written informed consent.
Exclusion criteria:
1. Other possible and treatable causes of syncope such as significant cardiac disease, cardiac arrhythmia or abnormalities of vertebro-basiliar arteries
2. History of stroke or TIA
3. History of cardiac surgery
4. Contraindications to ablation in the right or left atrium
Cardioneuroablation The procedure is performed under mild sedation (midazolam and fentanyl) using a 3.5 mm irrigated tip catheter (Navistar ThermoCool SmartTouch; Biosense Webster, Diamond Bar, California, USA) with contact force module and electroanatomical system Carto 3 (Biosense Webster, Diamond Bar, California, USA). After gaining transseptal access, an electroanatomical map of the right (RA) and left (LA) atrium is created and anatomically-based ablation of GP is performed. Ablation in the RA is started from the supero-posterior area (superior right atrial GP), to the middle-posterior area (posterior right atrial GP). In the LA, ablation is started at the site of the anterior right GP and is continued downwards along the anterior part of a common vestibulum of the right pulmonary veins (PV), opposite to the right-sided ablation lesions. Finally, area of right inferior GP, close to the RIPV is ablated under intracardiac echocardiography control. Using this technique, GP's located close to the left PV are not ablated. We use a pure anatomic approach without identification of GP by high-frequency stimulation or other imaging techniques.
Measurements.
1. Before CNA:
1. Detailed history taking and assessment of eligibility
2. Baseline 12-lead ECG for heart rate assessment, morphology and duration of the P wave and PR interval
3. 24-hour Holter ECG for heart rhythm (mean, minimal, maximal, pauses) and heart rate variability (HRV) assessment
4. Passive tilt test (70 degrees, 45 minutes) to fulfill inclusion criterion and to assess baseline autonomic parameters such as HRV and baroreflex sensitivity (BRS) using sequential method. These parameters will be calculated from 5 min recordings before and after orthostatic stress (tilt).
5. Atropine test - positive response to intravenous atropine in a dose of 2 mg defined as at least 30% increase in sinus rate compared with baseline value
6. Assessment of quality of life using the SF-36 questionnaire
7. Implantable Loop Recorder (ILR) implantation 2-3 days before CNA
2. During CNA:
1. Heart rate before and immediately after CNA
2. Episodes of bradycardia (sinus arrest or atrio-ventrocular block) during application of RF to GP.
3. Standard electrophysiological parameters (sinus node recovery time, corrected sinus recovery time, refractory atrio-ventricular node, atrio-ventricular conduction - Wenckebach point, A-H and H-V intervals) will be assessed before an immediately after CNA
4. Atropine test (2 mg) will be repeated immediately after CNA.
3. After CNA:
1. 1-2 days after CNA standard ECG
2. Follow-up: 3, 12 and 24 months after CNA assessment of symptoms, 12 lead standard ECG, control ILR, 24-hour Holter ECG, tilt test and atropine test will be performed. Additionally, quality of life will be assessed using SF-36 questionnaire
Definitions used for CNA efficacy assessment:
* Complete efficacy - no syncope or presyncope during two years of follow-up
* Partial efficacy - reduction of the number of syncopal (or presyncopal) episodes or change from syncopal to presyncopal episodes
Primary endpoint
\- Time to first syncope recurrence
Secondary endpoints
* Syncope burden (number of syncopal episodes during two years)
* Presyncope burden (number of presyncopal episodes during two years)
* ILR: assessed heart rate and atrio-ventricular conduction if syncope occurs
* CNA-induced changes in autonomic parameters
* Prognostic value of autonomic parameters.
* Safety of CNA: tamponade, stroke, phrenic nerve injury, permanent sinus arrest, local bleeding or vascular complications related to vascular access (hematoma / arteriovenous fistula)
Statistical analysis Results will be presented as mean ± SD or numbers and percentages. Also CNA-induced changes(∆) in analysed parameters will be calculated. The ECG, electrophysiological and autonomic parameters obtained before and after CNA will be compared using student t-test or Mann-Whitney test where appropriate. The values of analysed parameters in predicting CNA efficacy will be assessed by computing sensitivity, specificity, positive and negative predictive value. The ROC curves will be drawn in order to establish optimal cut-off points of analysed parameters in predicting CNA efficacy.
Anticipated results.
<!-- -->
1. CNA performed with technique used in the present study is effective in \> 90% of patients.
2. CNA-induced changes in analysed ECG and autonomic parameters predict CNA efficacy
Reflex syncope due to vasovagal reaction is the most frequent cause of transient loss of consciousness (TLOC) in general population. \[1-4\] It markedly decreases quality of life and may lead to injury. \[5, 6\] The mechanism of vasovagal syncope (VVS) is complex. One of the most important mechanisms is enhanced parasympathetic activity triggered by abnormal mechanoreceptor reflex and other mechanisms. This leads to prolonged asystole and/or vasodilatation, resulting in syncope. \[7\] Treatment of VVS remains a challenge. Non-pharmacological treatment such as fluid and salt intake, avoiding situations triggering syncope or tilt training is not effective in a significant proportion of subjects with syncope. Pharmacotherapy is even less effective. Syncope recurs in 25-65% of patients. Alternative therapy, especially in patients with prolonged asystole, is pacemaker implantation, recommended by the guidelines in patients aged \> 40 years with documented spontaneous cardioinhibitory VVS and severe symptoms. However, permanent pacing occurs ineffective in at least 25% of patients. In addition, VVS occurs predominantly in young persons in whom permanent pacing should be avoided as much as possible. \[8-13\] Thus, the need for new treatment options in VVS is clear.
Ablation for atrial fibrillation (AF) has been successfully performed for almost two decades. Apart from pulmonary vein isolation which is a corner stone of AF ablation, autonomic control of the heart is modified by ablation of ganglionated plexi (GP). It has been well documented that in some patients GP ablation increases the success rate of ablation, especially in patients with vagally-mediated AF. Thus, the technique of GP ablation, mainly using the radio-frequency energy, is well established and safe.
Based on data coming from GP ablation during AF procedures, this method has been recently proposed for patients with VVS. The postulated beneficial mechanisms of GP ablation in VVS are attenuation of parasympathetic activity, leading to elimination or reduction reflex asystole and bradycardia. To date, a few case series consisting of up to 70 patients demonstrated very promising results. \[15-18\]. However, this experience is limited to a few centers. Also, the optimal methodology of the procedure, called cardioneuroablation (CNA) or cardioneuromodulation, is not known. There is no consensus yet as to how many GP's, in both atria or only in the right atrium, in which order and to what extent should be ablated. Moreover, mechanisms responsible for beneficial effects of CNA as well as methods assessing it's efficacy are not clear.
Aim. To assess the effects of CNA on cardiac autonomic regulation and syncope recurrences in patients with VVS, and to compare this novel approach with standard non-pharmacological treatment.
Hypothesis. CNA using GP ablation causes significant changes in autonomic control of the heart, predominantly parasympathetic withdrawal, which is associated with long-term efficacy of the procedure, and is significantly more effective than standard non-pharmacological therapy.
Methods. This is an open-label, randomized, controlled, prospective study.
Study group. Forty consecutive patients with recurrent cardioinhibitory or mixed VVS will be included between August 2018 and July 2021.
The patients will be randomized into 2 groups:
1. Treatment arm (n=20): CNA
2. Control arm (n=20): standard non-pharmacological treatment The patients from the control arm will be allowed to cross over to the CNA group if syncopal episode occurs despite adherence to the non-pharmacological recommendations.
The number of 40 patients will be enough to demonstrate superiority of CNA over standard approach, assuming that the effectiveness of CNA will be over 90%, and the effectiveness of the standard non-pharmacological treatment will be 50%.
Inclusion criteria:
1. At least one documented spontaneous VVS during preceding 12 months or one syncope in history leading to injury and minimum 2 presyncopal events during preceding 12 months, refractory to all recommended types of standard treatment.
2. In case of lack of ECG documentation during spontaneous syncope and history suggesting reflex syncope, at least 3 seconds of asystole due to sinus arrest or atrio-ventricular block with syncope or bradycardia \<40 beats per minute with syncope or presyncope during baseline tilt test
3. Sinus rhythm during ECG and tilt test
4. Significantly decreased quality of life due to syncope
5. Positive response to atropine test
6. Obtained written informed consent.
Exclusion criteria:
1. Other possible and treatable causes of syncope such as significant cardiac disease, cardiac arrhythmia or abnormalities of vertebro-basiliar arteries
2. History of stroke or TIA
3. History of cardiac surgery
4. Contraindications to ablation in the right or left atrium
Cardioneuroablation The procedure is performed under mild sedation (midazolam and fentanyl) using a 3.5 mm irrigated tip catheter (Navistar ThermoCool SmartTouch; Biosense Webster, Diamond Bar, California, USA) with contact force module and electroanatomical system Carto 3 (Biosense Webster, Diamond Bar, California, USA). After gaining transseptal access, an electroanatomical map of the right (RA) and left (LA) atrium is created and anatomically-based ablation of GP is performed. Ablation in the RA is started from the supero-posterior area (superior right atrial GP), to the middle-posterior area (posterior right atrial GP). In the LA, ablation is started at the site of the anterior right GP and is continued downwards along the anterior part of a common vestibulum of the right pulmonary veins (PV), opposite to the right-sided ablation lesions. Finally, area of right inferior GP, close to the RIPV is ablated under intracardiac echocardiography control. Using this technique, GP's located close to the left PV are not ablated. We use a pure anatomic approach without identification of GP by high-frequency stimulation or other imaging techniques.
Measurements.
1. Before CNA:
1. Detailed history taking and assessment of eligibility
2. Baseline 12-lead ECG for heart rate assessment, morphology and duration of the P wave and PR interval
3. 24-hour Holter ECG for heart rhythm (mean, minimal, maximal, pauses) and heart rate variability (HRV) assessment
4. Passive tilt test (70 degrees, 45 minutes) to fulfill inclusion criterion and to assess baseline autonomic parameters such as HRV and baroreflex sensitivity (BRS) using sequential method. These parameters will be calculated from 5 min recordings before and after orthostatic stress (tilt).
5. Atropine test - positive response to intravenous atropine in a dose of 2 mg defined as at least 30% increase in sinus rate compared with baseline value
6. Assessment of quality of life using the SF-36 questionnaire
7. Implantable Loop Recorder (ILR) implantation 2-3 days before CNA
2. During CNA:
1. Heart rate before and immediately after CNA
2. Episodes of bradycardia (sinus arrest or atrio-ventrocular block) during application of RF to GP.
3. Standard electrophysiological parameters (sinus node recovery time, corrected sinus recovery time, refractory atrio-ventricular node, atrio-ventricular conduction - Wenckebach point, A-H and H-V intervals) will be assessed before an immediately after CNA
4. Atropine test (2 mg) will be repeated immediately after CNA.
3. After CNA:
1. 1-2 days after CNA standard ECG
2. Follow-up: 3, 12 and 24 months after CNA assessment of symptoms, 12 lead standard ECG, control ILR, 24-hour Holter ECG, tilt test and atropine test will be performed. Additionally, quality of life will be assessed using SF-36 questionnaire
Definitions used for CNA efficacy assessment:
* Complete efficacy - no syncope or presyncope during two years of follow-up
* Partial efficacy - reduction of the number of syncopal (or presyncopal) episodes or change from syncopal to presyncopal episodes
Primary endpoint
\- Time to first syncope recurrence
Secondary endpoints
* Syncope burden (number of syncopal episodes during two years)
* Presyncope burden (number of presyncopal episodes during two years)
* ILR: assessed heart rate and atrio-ventricular conduction if syncope occurs
* CNA-induced changes in autonomic parameters
* Prognostic value of autonomic parameters.
* Safety of CNA: tamponade, stroke, phrenic nerve injury, permanent sinus arrest, local bleeding or vascular complications related to vascular access (hematoma / arteriovenous fistula)
Statistical analysis Results will be presented as mean ± SD or numbers and percentages. Also CNA-induced changes(∆) in analysed parameters will be calculated. The ECG, electrophysiological and autonomic parameters obtained before and after CNA will be compared using student t-test or Mann-Whitney test where appropriate. The values of analysed parameters in predicting CNA efficacy will be assessed by computing sensitivity, specificity, positive and negative predictive value. The ROC curves will be drawn in order to establish optimal cut-off points of analysed parameters in predicting CNA efficacy.
Anticipated results.
<!-- -->
1. CNA performed with technique used in the present study is effective in \> 90% of patients.
2. CNA-induced changes in analysed ECG and autonomic parameters predict CNA efficacy
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Syncope, Vasovagal
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
TREATMENT
Blinding Strategy
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Treatment arm
Patients treated with cardioneuroablation.
Group Type
EXPERIMENTAL
Cardioneuroablation
Intervention Type
PROCEDURE
The electroanatomical map of the right (RA) and left (LA) atrium will be created and anatomically-based ablation of GP will be performed. Ablation in the RA is started from the supero-posterior area (superior right atrial GP), to the middle-posterior area (posterior right atrial GP). In the LA, ablation is started at the site of the anterior right GP and is continued downwards along the anterior part of a common vestibulum of the right pulmonary veins (PV), opposite to the right-sided ablation lesions. Finally, area of right inferior GP, close to the RIPV is ablated under intracardiac echocardiography control. Using this technique, GP's located close to the left PV are not ablated. We use a pure anatomic approach without identification of GP.
Control arm
Patients treated with standard non-pharmacological methods.
Group Type
ACTIVE_COMPARATOR
Cardioneuroablation
Intervention Type
PROCEDURE
The electroanatomical map of the right (RA) and left (LA) atrium will be created and anatomically-based ablation of GP will be performed. Ablation in the RA is started from the supero-posterior area (superior right atrial GP), to the middle-posterior area (posterior right atrial GP). In the LA, ablation is started at the site of the anterior right GP and is continued downwards along the anterior part of a common vestibulum of the right pulmonary veins (PV), opposite to the right-sided ablation lesions. Finally, area of right inferior GP, close to the RIPV is ablated under intracardiac echocardiography control. Using this technique, GP's located close to the left PV are not ablated. We use a pure anatomic approach without identification of GP.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Cardioneuroablation
The electroanatomical map of the right (RA) and left (LA) atrium will be created and anatomically-based ablation of GP will be performed. Ablation in the RA is started from the supero-posterior area (superior right atrial GP), to the middle-posterior area (posterior right atrial GP). In the LA, ablation is started at the site of the anterior right GP and is continued downwards along the anterior part of a common vestibulum of the right pulmonary veins (PV), opposite to the right-sided ablation lesions. Finally, area of right inferior GP, close to the RIPV is ablated under intracardiac echocardiography control. Using this technique, GP's located close to the left PV are not ablated. We use a pure anatomic approach without identification of GP.
Intervention Type
PROCEDURE
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Cardioneuromodulation
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* At least one documented spontaneous VVS during preceding 12 months or one syncope in history leading to injury and minimum 2 presyncopal events during preceding 12 months, refractory to all recommended types of standard treatment.
* In case of lack of ECG documentation during spontaneous syncope and history suggesting reflex syncope, at least 3 seconds of asystole due to sinus arrest or atrio-ventricular block with syncope or bradycardia \<40 beats per minute with syncope or presyncope during baseline tilt test
* Sinus rhythm during ECG and tilt test
* Significantly decreased quality of life due to syncope
* Positive response to atropine test
* Obtained written informed consent.
* In case of lack of ECG documentation during spontaneous syncope and history suggesting reflex syncope, at least 3 seconds of asystole due to sinus arrest or atrio-ventricular block with syncope or bradycardia \<40 beats per minute with syncope or presyncope during baseline tilt test
* Sinus rhythm during ECG and tilt test
* Significantly decreased quality of life due to syncope
* Positive response to atropine test
* Obtained written informed consent.
Exclusion Criteria
* Other possible and treatable causes of syncope such as significant cardiac disease, cardiac arrhythmia or abnormalities of vertebro-basiliar arteries
* History of stroke or TIA
* History of cardiac surgery
* Contraindications to ablation in the right or left atrium
* History of stroke or TIA
* History of cardiac surgery
* Contraindications to ablation in the right or left atrium
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Centre of Postgraduate Medical Education
OTHER
Sponsor Role
lead
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Prof. Piotr Kulakowski
Principal Investigator
Responsibility Role
PRINCIPAL_INVESTIGATOR
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Piotr Kulakowski, Prof.
Role: STUDY_CHAIR
Centre of Postgraduate Medical Education
Roman Piotrowski, MD, PhD
Role: STUDY_CHAIR
Centre of Postgraduate Medical Education
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Department of Cardiology, Postgraduate Medical School, Grochowski Hospital
Warsaw, Masovian Voivodeship, Poland
Site Status
Countries
Review the countries where the study has at least one active or historical site.
Poland
References
Explore related publications, articles, or registry entries linked to this study.
Brignole M, Moya A, de Lange FJ, Deharo JC, Elliott PM, Fanciulli A, Fedorowski A, Furlan R, Kenny RA, Martin A, Probst V, Reed MJ, Rice CP, Sutton R, Ungar A, van Dijk JG; ESC Scientific Document Group. 2018 ESC Guidelines for the diagnosis and management of syncope. Eur Heart J. 2018 Jun 1;39(21):1883-1948. doi: 10.1093/eurheartj/ehy037. No abstract available.
Reference Type
RESULT
Grubb BP. Clinical practice. Neurocardiogenic syncope. N Engl J Med. 2005 Mar 10;352(10):1004-10. doi: 10.1056/NEJMcp042601. No abstract available.
Reference Type
RESULT
Mathias CJ, Deguchi K, Schatz I. Observations on recurrent syncope and presyncope in 641 patients. Lancet. 2001 Feb 3;357(9253):348-53. doi: 10.1016/S0140-6736(00)03642-4.
Reference Type
RESULT
Sheldon RS, Grubb BP 2nd, Olshansky B, Shen WK, Calkins H, Brignole M, Raj SR, Krahn AD, Morillo CA, Stewart JM, Sutton R, Sandroni P, Friday KJ, Hachul DT, Cohen MI, Lau DH, Mayuga KA, Moak JP, Sandhu RK, Kanjwal K. 2015 heart rhythm society expert consensus statement on the diagnosis and treatment of postural tachycardia syndrome, inappropriate sinus tachycardia, and vasovagal syncope. Heart Rhythm. 2015 Jun;12(6):e41-63. doi: 10.1016/j.hrthm.2015.03.029. Epub 2015 May 14. No abstract available.
Reference Type
RESULT
Rose MS, Koshman ML, Spreng S, Sheldon R. The relationship between health-related quality of life and frequency of spells in patients with syncope. J Clin Epidemiol. 2000 Dec;53(12):1209-16. doi: 10.1016/s0895-4356(00)00257-2.
Reference Type
RESULT
Bartoletti A, Fabiani P, Bagnoli L, Cappelletti C, Cappellini M, Nappini G, Gianni R, Lavacchi A, Santoro GM. Physical injuries caused by a transient loss of consciousness: main clinical characteristics of patients and diagnostic contribution of carotid sinus massage. Eur Heart J. 2008 Mar;29(5):618-24. doi: 10.1093/eurheartj/ehm563. Epub 2007 Dec 16.
Reference Type
RESULT
Chen-Scarabelli C, Scarabelli TM. Neurocardiogenic syncope. BMJ. 2004 Aug 7;329(7461):336-41. doi: 10.1136/bmj.329.7461.336. No abstract available.
Reference Type
RESULT
Brignole M, Menozzi C, Moya A, Andresen D, Blanc JJ, Krahn AD, Wieling W, Beiras X, Deharo JC, Russo V, Tomaino M, Sutton R; International Study on Syncope of Uncertain Etiology 3 (ISSUE-3) Investigators. Pacemaker therapy in patients with neurally mediated syncope and documented asystole: Third International Study on Syncope of Uncertain Etiology (ISSUE-3): a randomized trial. Circulation. 2012 May 29;125(21):2566-71. doi: 10.1161/CIRCULATIONAHA.111.082313. Epub 2012 May 7.
Reference Type
RESULT
Aydin MA, Mortensen K, Salukhe TV, Wilke I, Ortak M, Drewitz I, Hoffmann B, Mullerleile K, Sultan A, Servatius H, Steven D, von Kodolitsch Y, Meinertz T, Ventura R, Willems S. A standardized education protocol significantly reduces traumatic injuries and syncope recurrence: an observational study in 316 patients with vasovagal syncope. Europace. 2012 Mar;14(3):410-5. doi: 10.1093/europace/eur341. Epub 2011 Nov 1.
Reference Type
RESULT
Sheldon RS, Morillo CA, Klingenheben T, Krahn AD, Sheldon A, Rose MS. Age-dependent effect of beta-blockers in preventing vasovagal syncope. Circ Arrhythm Electrophysiol. 2012 Oct;5(5):920-6. doi: 10.1161/CIRCEP.112.974386. Epub 2012 Sep 12.
Reference Type
RESULT
Tan MP, Newton JL, Chadwick TJ, Gray JC, Nath S, Parry SW. Home orthostatic training in vasovagal syncope modifies autonomic tone: results of a randomized, placebo-controlled pilot study. Europace. 2010 Feb;12(2):240-6. doi: 10.1093/europace/eup368. Epub 2009 Nov 17.
Reference Type
RESULT
Romme JJ, van Dijk N, Go-Schon IK, Reitsma JB, Wieling W. Effectiveness of midodrine treatment in patients with recurrent vasovagal syncope not responding to non-pharmacological treatment (STAND-trial). Europace. 2011 Nov;13(11):1639-47. doi: 10.1093/europace/eur200. Epub 2011 Jul 13.
Reference Type
RESULT
Raviele A, Giada F, Menozzi C, Speca G, Orazi S, Gasparini G, Sutton R, Brignole M; Vasovagal Syncope and Pacing Trial Investigators. A randomized, double-blind, placebo-controlled study of permanent cardiac pacing for the treatment of recurrent tilt-induced vasovagal syncope. The vasovagal syncope and pacing trial (SYNPACE). Eur Heart J. 2004 Oct;25(19):1741-8. doi: 10.1016/j.ehj.2004.06.031.
Reference Type
RESULT
Yao Y, Shi R, Wong T, Zheng L, Chen W, Yang L, Huang W, Bao J, Zhang S. Endocardial autonomic denervation of the left atrium to treat vasovagal syncope: an early experience in humans. Circ Arrhythm Electrophysiol. 2012 Apr;5(2):279-86. doi: 10.1161/CIRCEP.111.966465. Epub 2012 Jan 24.
Reference Type
RESULT
Pachon JC, Pachon EI, Cunha Pachon MZ, Lobo TJ, Pachon JC, Santillana TG. Catheter ablation of severe neurally meditated reflex (neurocardiogenic or vasovagal) syncope: cardioneuroablation long-term results. Europace. 2011 Sep;13(9):1231-42. doi: 10.1093/europace/eur163. Epub 2011 Jun 28.
Reference Type
RESULT
Aksu T, Golcuk E, Yalin K, Guler TE, Erden I. Simplified Cardioneuroablation in the Treatment of Reflex Syncope, Functional AV Block, and Sinus Node Dysfunction. Pacing Clin Electrophysiol. 2016 Jan;39(1):42-53. doi: 10.1111/pace.12756. Epub 2015 Oct 26.
Reference Type
RESULT
Sun W, Zheng L, Qiao Y, Shi R, Hou B, Wu L, Guo J, Zhang S, Yao Y. Catheter Ablation as a Treatment for Vasovagal Syncope: Long-Term Outcome of Endocardial Autonomic Modification of the Left Atrium. J Am Heart Assoc. 2016 Jul 8;5(7):e003471. doi: 10.1161/JAHA.116.003471.
Reference Type
RESULT
Piotrowski R, Baran J, Kulakowski P. Cardioneuroablation using an anatomical approach: a new and promising method for the treatment of cardioinhibitory neurocardiogenic syncope. Kardiol Pol. 2018;76(12):1736-1738. doi: 10.5603/KP.a2018.0200. Epub 2018 Oct 19. No abstract available.
Reference Type
RESULT
Piotrowski R, Baran J, Sikorska A, Krynski T, Kulakowski P. Cardioneuroablation for Reflex Syncope: Efficacy and Effects on Autonomic Cardiac Regulation-A Prospective Randomized Trial. JACC Clin Electrophysiol. 2023 Jan;9(1):85-95. doi: 10.1016/j.jacep.2022.08.011. Epub 2022 Aug 28.
Reference Type
DERIVED
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
113/PB/2018
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.
Efficacy of Transcatheter Ablation Using Anatomic Approach of Ganglionated Plexi Located in the Right Atrium to Prevent Neuromediated Cardioinhibitory Syncope
NCT01814228
COMPLETED
NA
Cardioneuroablation for Neurocardiogenic Syncope
NCT02009982
COMPLETED
NA
POLish Registry of CArdioneuroablation and CArdioneuromodulation
NCT07196397
RECRUITING
Optimizing Diagnostics Of Syncope Events Using Intelligent Telemetric Solutions.
NCT01265290
UNKNOWN
NA
National Registry of Cardioneuroablation in Recurrent Reflex Syncope
NCT06159764
RECRUITING
Botulinum Toxin Injection to Prevent Ventricular Arrhythmias
NCT02003001
UNKNOWN
PHASE1
Telemetric Arrhythmia and Syncope Diagnosis - Evaluation of Arrhythmia Treatment Efficacy
NCT01265303
UNKNOWN
NA
Guideline-based Pacing Therapy for Reflex Syncope
NCT01509534
COMPLETED
Efficacy of a Right-sided Ablation of the Anterior Ganglionated Plexus for Neurally Mediated Syncope
NCT04755101
RECRUITING
NA
Vagal Response and Cardiac Autonomic Modulation. Insides From Cryoballoon Ablation
NCT04896424
COMPLETED
NA
Electrophysiological Mechanisms and Inhibitory Cardiac Syncope
NCT02861274
COMPLETED
PHASE1
Bradycardia Risk Stratification With Loop Recorder After Syncope
NCT04200014
UNKNOWN
Inducibility and Stability of Ventricular Tachycardia Inpatients Undergoing VT Ablation Under General Anesthesia
NCT02419547
COMPLETED
NA
Diagnosis of Arrhythmias in Syncope by Pocket-ECG III® or Conventional Holter
NCT02614235
COMPLETED
NA
Comparison of the Efficacy and Safety of Cardioneuroablation to Permanent Pacing in Patients With an Implanted Pacemaker for Symptomatic Bradycardia.
NCT05896592
RECRUITING
NA
ISSUE3: International Study on Syncope of Uncertain Etiology 3
NCT00359203
COMPLETED
PHASE4
Cardioneuroablation Versus Pacemaker Implantation for the Treatment of Symptomatic Sinus Node Dysfunction
NCT05186220
UNKNOWN
NA
Risk of Syncopal Relapses in Patients Treated With Permanent Pacing for Bradyarrhythmic Syncope
NCT04229589
UNKNOWN
Modification of Rhythmic Risk Assessment by Ventricular Tachycardia Ablation
NCT03453645
UNKNOWN
Impact of Catheter Ablation of Frequent Premature Ventricular Complexes in Treating Subtle Left Cardiomyopathy
NCT06864429
COMPLETED
NA
Safety of Local Dental Anesthesia in Patients With Cardiac Channelopathies
NCT03182777
COMPLETED
NA
Atropine vs Isoprenaline in the Invasive Diagnosis of Arrhythmias
NCT06082388
NOT_YET_RECRUITING
NA
Can Medical Personnel Properly Proceed in the Case of a Patient With Bradycardia?
NCT02711748
UNKNOWN
NA
Mobile Cardiac Outpatient Telemetry for Unexplained Syncope
NCT05957315
UNKNOWN
NA
Cardioneuroablation for Bradyarrhythmia
NCT06288633
RECRUITING
NA