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Trial record 18 of 20 for:    Brugada Syndrome 1

Efficacy of Transcatheter Ablation Using Anatomic Approach of Ganglionated Plexi Located in the Right Atrium to Prevent Neuromediated Cardioinhibitory Syncope

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ClinicalTrials.gov Identifier: NCT01814228
Recruitment Status : Recruiting
First Posted : March 19, 2013
Last Update Posted : April 6, 2018
Sponsor:
Information provided by (Responsible Party):
Leonardo Calo, Policlinico Casilino ASL RMB

Tracking Information
First Submitted Date  ICMJE March 15, 2013
First Posted Date  ICMJE March 19, 2013
Last Update Posted Date April 6, 2018
Study Start Date  ICMJE September 2013
Estimated Primary Completion Date December 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 15, 2013)
neuromediated cardioinhibitory syncope recurrence [ Time Frame: 1 year ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01814228 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy of Transcatheter Ablation Using Anatomic Approach of Ganglionated Plexi Located in the Right Atrium to Prevent Neuromediated Cardioinhibitory Syncope
Official Title  ICMJE Efficacy of Transcatheter Ablation Using Anatomic Approach of Ganglionated Plexi Located in the Right Atrium to Prevent Neuromediated Cardioinhibitory Syncope
Brief Summary

Cardioinhibitory neurocardiogenic syncope (CNS) or vasovagal syncope, is the most frequent aetiology of syncope in young people without apparent cardiac or neurological pathology. It is usually caused by inappropriately trigger-activated cardiac reflex which finally precipitates asystole, sinus bradycardia, or atrioventricular (AV) block [1]. Despite young patients affected by CNS have an excellent prognosis when electro-structural heart diseases are excluded [2], their quality of life may be seriously affected by recurrent episodes [2, 3]. Cardiac pacing might help to control symptoms and therefore is considered in patients aged more than 40 years old with recurrent episodes and documented cardioinhibitory response [1, 4]. In young individuals, the role of cardiac pacing is dubious due to predicted frequent device substitutions and adverse ventricular remodeling over time. Recently, radiofrequency (RF) biatrial ablation of ganglionated plexi (GP) has showed promising results in the short and long-term treatment of reflex syncope, functional atrioventricular block, or sinus node dysfunction [5, 6]. Nonetheless, strong evidences are emerging about efficacy of transcatheter ablation limited to ganglionated plexi in the right atrium with the possibility to avoid side-effects related to left-sided procedures [6]

Aim of study

To evaluate in a large cohort of patients effectiveness and safety of gangliar transcatheter ablation in the right atrium to obtain atrial denervation and prevent CNS.

Study population and methods

Twenty consecutive patients affected by cardioinhibitory neurocardiogenic syncope will be enrolled in the study.

Inclusion criteria:

  • age between 18 and 60 years
  • 3 syncopal episodes at least of likely CNS in the previous 2 years
  • marked cardioinhibitory response to HUT or documented asystolic pauses at internal loop recorder registration [7].

Cardioinhibition will be considered as elicitation of asystolic pause (sinus arrest or AV block) ≥ 3 seconds associated to syncope or ≥ 6 seconds and related presyncope.

Exclusion criteria:

  • documented myocardial and/or valvular abnormalities on 2D echocardiogram (ejection fraction lower than 50%)
  • documented tachyarrhythmias as possible causes of symptoms
  • channelopathies (Brugada syndrome, LQT or SQT syndrome)
  • ventricular preexcitation
  • symptomatic orthostatic hypotension diagnosed by standing blood pressure measurement
  • pregnancy in women
  • previous cardiac pacemaker implantation.

After obtaining informed consent patients will undergo to basal electrophysiological study (EPS) to record AH interval, HV interval, Wenckebach cycle length, sinus node recovery time (SNRT) and correct sinus node recovery time (cSNRT); the same parameters will be recorded immediately after ablation. Following basal EPS an accurate (200 valid points at least) electroanatomic right atrium mapping (CARTO 3™ Biosense Webster, Inc) will be performed and subsequently radiofrequency delivered at right atrial anatomic sites where the underlying presence of ganglionated plexi (GPs) clusters was regarded as highly probable, on the basis of anatomical studies [8-11]: the supero-posterior area (superior right atrial GP, adjacent to the junction of the superior vena cava and the posterior surface of RA), the middleposterior area (posterior right atrial GP, posterior surface of the RA adjacent the interatrial groove), the infero-posterior area (inferior right GP placed between the inferior vena cava, coronary sinus ostium, and near the atrioventricular groove). Transcatheter ablation will be performed using an 8mm-tip catheter (Biosence-Webster Navistar DS 8mm) or an irrigated 4 mm-tip catheter with force control system (Biosence Webster Smarttouch). Ablation will be performed until complete elimination of local atrial electrical activity. Response to radiofrequencies delivery will be considered successful in case of asystolic pause or cardiac cycle lengthening of 30% (compared to basal cycle) at least. To prolong RF delivery despite asystolic response, a quadripolar catheter will be positioned in right ventricle to backup stimulation. To avoid phrenic nerve injury, high amplitude stimulation will be performed just before radiofrequency delivery to the superior right atrial GP.

HRV analysis will be performed on admission, at 2 hour after ablation and patients discharge. The HRV analysis will include the following parameters: mean, maximal and minimal heart rate, SDNN (standard deviation of Normal-Normal), RMSSD (root mean square successive difference), pNN50 (percentage of differences between adjacent N-N intervals that are >50 msec), LF (low frequency), HF (high frequency).

Moreover, an HUT and an HRV analysis will be performed at 1, 3, 6 and 12 months after ablation procedure during the follow up.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Neuromediated Cardioinhibitory Syncope
Intervention  ICMJE Procedure: transcatheter ablation of ganglionated plexi in right atrium
Study Arms  ICMJE Experimental: right atrium ganglionated plexi transcatheter ablation
right atrium ganglionated plexi transcatheter ablation
Intervention: Procedure: transcatheter ablation of ganglionated plexi in right atrium
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: November 13, 2013)
20
Original Enrollment  ICMJE Not Provided
Estimated Study Completion Date  ICMJE December 2021
Estimated Primary Completion Date December 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Twenty consecutive patients affected by cardioinhibitory neurocardiogenic syncope will be enrolled in the study.

Inclusion criteria:

  • age between 18 and 60 years
  • 3 syncopal episodes at least of likely CNS in the previous 2 years
  • marked cardioinhibitory response to HUT or documented asystolic pauses at internal loop recorder registration [7].

Cardioinhibition will be considered as elicitation of asystolic pause (sinus arrest or AV block) ≥ 3 seconds associated to syncope or ≥ 6 seconds and related presyncope.

Exclusion criteria:

  • documented myocardial and/or valvular abnormalities on 2D echocardiogram (ejection fraction lower than 50%)
  • documented tachyarrhythmias as possible causes of symptoms
  • channelopathies (Brugada syndrome, LQT or SQT syndrome)
  • ventricular preexcitation
  • symptomatic orthostatic hypotension diagnosed by standing blood pressure measurement
  • pregnancy in women
  • previous cardiac pacemaker implantation.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Listed Location Countries  ICMJE Italy
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01814228
Other Study ID Numbers  ICMJE Casilino0001, 0002
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Leonardo Calo, Policlinico Casilino ASL RMB
Study Sponsor  ICMJE Policlinico Casilino ASL RMB
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Policlinico Casilino ASL RMB
Verification Date April 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP