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Trial record 11 of 42 for:    Syncope | Child

Cardioneuroablation for Reflex Syncope (ROMAN)

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ClinicalTrials.gov Identifier: NCT03903744
Recruitment Status : Recruiting
First Posted : April 4, 2019
Last Update Posted : April 4, 2019
Sponsor:
Information provided by (Responsible Party):
Prof. Piotr Kulakowski, Centre of Postgraduate Medical Education

Brief Summary:

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

Condition or disease Intervention/treatment Phase
Syncope, Vasovagal Procedure: Cardioneuroablation Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: CardioneuROablation for Reflex Syncope: Effects on autonoMic cArdiac Regulation and Efficacy Assessment - the Roman Syncope Study.
Actual Study Start Date : November 1, 2018
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fainting

Arm Intervention/treatment
Experimental: Treatment arm
Patients treated with cardioneuroablation.
Procedure: 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.
Other Name: Cardioneuromodulation

Active Comparator: Control arm
Patients treated with standard non-pharmacological methods.
Procedure: 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.
Other Name: Cardioneuromodulation




Primary Outcome Measures :
  1. Time to first syncope recurrence. [ Time Frame: Two-year follow-up after starting treatment. ]
    Recurrence of syncope (in days) after using the appropriate method (cardioneuroablation or standard non-pharmacological treatment).


Secondary Outcome Measures :
  1. Syncope burden. [ Time Frame: Two-year follow-up after starting treatment. ]
    Number of syncopal episodes (number of events during two-year follow-up).

  2. Presyncope burden. [ Time Frame: Two-year follow-up. ]
    Number of presyncopal episodes (number of events during two-year follow-up).

  3. Heart rate and atrio-ventricular conduction if syncope occurs. [ Time Frame: Two-year follow-up. ]
    Heart rate (beats/min) and longest pause (seconds) (based on ILR monitoring during syncope).

  4. Cardioneuroablation-induced changes in heart rate variability predicting ablation efficacy. [ Time Frame: 3, 12 and 24 months after cardioneuroablation. ]
    Cardioneuroablation-induced changes in heart rate variability (SDNN in msec) will be analyzed as a predictor of ablation efficacy.

  5. Cardioneuroablation-induced changes in baroreflex sensitivity predicting ablation efficacy. [ Time Frame: Two-year follow-up. ]
    Cardioneuroablation-induced changes in baroreflex sensitivity (msec/mmHg) will be analyzed as a predictor of ablation efficacy.

  6. Complications associated with CNA procedure [ Time Frame: Two-year follow-up. ]
    Assessment of possible complications: tamponade, stroke, phrenic nerve injury,(permanent sinus arrest, local bleeding or vascular complications related to vascular access (hematoma / arteriovenous fistula) - number of events.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03903744


Contacts
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Contact: Piotr Kulakowski, Prof. +48 22 51 52 757 kulak@kkcmkp.pl
Contact: Roman Piotrowski, MD, PhD +48 22 51 52 757 rpiotrow@op.pl

Locations
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Poland
Department of Cardiology, Postgraduate Medical School, Grochowski Hospital Recruiting
Warsaw, Masovian, Poland, 04-073
Contact: Piotr Kulakowski, Prof.    +48 22 51 52 757    kulak@kkcmkp.pl   
Contact: Roman Piotrowski, MD, PhD    +48 22 51 52 757    rpiotrow@op.pl   
Sponsors and Collaborators
Centre of Postgraduate Medical Education
Investigators
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Study Chair: Piotr Kulakowski, Prof. Centre of Postgraduate Medical Education
Study Chair: Roman Piotrowski, MD, PhD Centre of Postgraduate Medical Education

Publications of Results:

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Responsible Party: Prof. Piotr Kulakowski, Principal Investigator, Centre of Postgraduate Medical Education
ClinicalTrials.gov Identifier: NCT03903744     History of Changes
Other Study ID Numbers: 113/PB/2018
First Posted: April 4, 2019    Key Record Dates
Last Update Posted: April 4, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Prof. Piotr Kulakowski, Centre of Postgraduate Medical Education:
syncope
cardioneuroablation
cardioneuromodulation
Additional relevant MeSH terms:
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Syncope
Syncope, Vasovagal
Unconsciousness
Consciousness Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Orthostatic Intolerance
Primary Dysautonomias
Autonomic Nervous System Diseases