Clinical trial NCT02072473: Safety and Efficacy Aspects of a Standardized Stepwise Anatomical Approach for AVNRT Ablation
Official title: Safety and Efficacy Aspects of a Standardized Stepwise Anatomical Approach for Atrio-Ventricular Nodal Re-entrant Tachycardia Ablation
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Re-entrant Atrioventricular Node Tachycardia
Keywords: Re-entrant Atrioventricular Node Tachycardia
Unsuccessful right-sided slow pathway ablation
Coronary sinus / left-sided slow pathway ablation
Lead sponsor: Sheba Medical Center
Sponsor class: OTHER_GOV
First posted: 2014-02-26
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Symptomatic AVNRT patients undergoing ablation procedure

Brief summary: This proposal aims to evaluate safety and efficacy aspects of a new protocol for AVNRT ablation, using a stepwise anatomical approach.

The investigators hypothesize that the use of a standardized electro-anatomical guided strategy, using a sequential approach as follows:

1. Right-side postero-septal tricuspid annulus
2. Coronary sinus
3. Left-side postero-septal mitral annulus

For slow pathway AVNRT ablation is safe and efficient, increasing the chance of a successful ablation in difficult cases, while reducing the need of re-do procedures and the risk for high-degree atrio-ventricular block.

The investigators aim to define and implement a new standardized protocol for AVNRT ablation while at the same time assessing the efficacy and safety of coronary sinus and left-side approaches for slow-pathway ablation.

Detailed description: Atrio-ventricular nodal reentrant tachycardia (AVNRT) is the most common form of supraventricular tachycardia in adults. The substrate of AVNRT is dual nodal atrio-ventricular (AV) physiology represented by the presence of slow (SP) and fast pathway (FP) conduction. Selective radiofrequency (RF) ablation of the slow AV nodal pathway can cure the arrhythmia with acute success rates varying from 95 to 98% and low recurrence rates during long-term follow-up.

The compact AV node sends two posterior extensions with node-like tissue distributed towards the coronary sinus and tricuspid annulus (right posterior extension) and towards the mitral annulus (left posterior extension). Earlier literature suggested that the right posterior nodal extension is involved in the tachycardia circuit of most patients with AVNRT (slow pathway input). The tachycardia circuit may rarely involve the left posterior nodal extension, in which case a left-sided ablation procedure is needed. The right-sided approach is sufficient for the majority of cases and represents today the standard protocol for AVNRT ablation.

Lee et Al., in view of current anatomical and electrophysiological knowledge concerning the AV node, proposed the following sequential approach for SP ablation:

I. the isthmus between tricuspid annulus and coronary sinus ostium (the usual site of slow pathway), II. the tricuspid edge of coronary sinus ostium (by moving the ablation catheter tip slightly in and out of the coronary sinus), III. the septum lower than coronary sinus ostium, moving higher up on the half of Koch's triangle along the septum, IV. one or two burns inside the first few centimeters of the coronary sinus, V. left side of the septum (last).

The investigators hypothesize that the use of a standardized electro-anatomical guided strategy, using a sequential approach as follows:

1. Right-side postero-septal tricuspid annulus
2. Coronary sinus
3. Left-side postero-septal mitral annulus

for slow pathway AVNRT ablation is safe and efficient, increasing the chance of a successful ablation in difficult cases, while reducing the need of re-do procedures and the risk for high-degree atrio-ventricular block.

The protocol will be applied in all patients undergoing slow pathway ablation for typical AVNRT. Those with unsuccessful right-sided attempt and who undergo coronary sinus and left-sided ablation attempt will be eligible for registry inclusion.

Eligibility criteria: Inclusion Criteria:

1. Age \> 18 and \<80 years
2. History of symptomatic PSVT
3. Signed informed consent
4. Documented AVNRT during EPS with at least 1 of the following:

   * Previous unsuccessful right-sided ablation attempt
   * Ideal SP electrogram at XR \< 10 mm in RAO 30°
   * Right-sided ablation attempt with:

     * VA block during JB or
     * A minimum of 7 unsuccessful RF energy deliveries, with no upper limit (to the 1st operator's discretion)

Exclusion Criteria:

* Previous CVA
* Severe mitral or aortic valve disease
* Documented intra-cardiac thrombus

Primary outcomes:
measure: Slow pathway modification/elimination
timeFrame: Up to 6 hours
Secondary outcomes:
measure: Time to AVNRT recurrence
timeFrame: Up to 6 Months
measure: High-degree AV block requiring permanent pace-maker
timeFrame: Up to 48 hours
measure: Cardiac tamponade
timeFrame: Up to 48 hours
measure: Systemic embolic events
timeFrame: Up to 48 hours
measure: Transient AV conduction disturbance
timeFrame: Up to 48 hours
measure: Peripheral arterio-venous complications
timeFrame: Up to 48 hours
measure: Number of Participants with Adverse Events as a Measure of Safety and Tolerability
timeFrame: Up to 48 hours
Other outcomes:
Locations:
city: Ramat Gan
country: Israel
facility: Sheba Medical Center
Study officials:
affiliation: Sheba Medical Center
name: Roy Beinart, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: McGuire MA, Robotin M, Yip AS, Bourke JP, Johnson DC, Dewsnap BI, Grant P, Uther JB, Ross DL. Electrophysiologic and histologic effects of dissection of the connections between the atrium and posterior part of the atrioventricular node. J Am Coll Cardiol. 1994 Mar 1;23(3):693-701. doi: 10.1016/0735-1097(94)90756-0.
citation: Inoue S, Becker AE. Posterior extensions of the human compact atrioventricular node: a neglected anatomic feature of potential clinical significance. Circulation. 1998 Jan 20;97(2):188-93. doi: 10.1161/01.cir.97.2.188.
citation: Kilic A, Amasyali B, Kose S, Aytemir K, Celik T, Kursaklioglu H, Iyisoy A, Ozmen N, Yuksel C, Lenk MK, Isik E. Atrioventricular nodal reentrant tachycardia ablated from left atrial septum: clinical and electrophysiological characteristics and long-term follow-up results as compared to conventional right-sided ablation. Int Heart J. 2005 Nov;46(6):1023-31. doi: 10.1536/ihj.46.1023.
citation: Katritsis DG, Giazitzoglou E, Zografos T, Ellenbogen KA, Camm AJ. An approach to left septal slow pathway ablation. J Interv Card Electrophysiol. 2011 Jan;30(1):73-9. doi: 10.1007/s10840-010-9527-z. Epub 2010 Dec 14.
citation: Lee PC, Chen SA, Hwang B. Atrioventricular node anatomy and physiology: implications for ablation of atrioventricular nodal reentrant tachycardia. Curr Opin Cardiol. 2009 Mar;24(2):105-12. doi: 10.1097/HCO.0b013e328323d83f.