Safety and Efficacy Aspects of a Standardized Stepwise Anatomical Approach for AVNRT Ablation

Re-entrant Atrioventricular Node Tachycardia Clinical Trial

Official title:

Safety and Efficacy Aspects of a Standardized Stepwise Anatomical Approach for Atrio-Ventricular Nodal Re-entrant Tachycardia Ablation

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02072473
• Other study ID #: SHEBA-0716-13-RB-CTIL
• Status: Withdrawn
• Phase: N/A
• First received: February 10, 2014
• Last updated: October 18, 2016
• Start date: September 2014
• Est. completion date: April 2016

Study information

• Verified date: October 2016
• Source: Sheba Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: April 2016
• Est. primary completion date: April 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Re-entrant Atrioventricular Node Tachycardia
• Tachycardia
• Tachycardia, Atrioventricular Nodal Reentry

Intervention

Procedure:
• Coronary sinus / left-sided slow pathway ablation
Patients with unsuccessful right-sided slow pathway ablation attempt will undergo a stepwise: coronary sinus slow pathway ablation, which, if unsuccessful, will be followed by left-sided slow pathway ablation, using trans-septal approach.

Locations

Country	Name	City	State
Israel	Sheba Medical Center	Ramat Gan

Sponsors (1)

Lead Sponsor	Collaborator
Sheba Medical Center

Country where clinical trial is conducted

Israel, 

References & Publications (5)

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. Erratum in: Circulation 1998 Mar 31;97(12):1216. — View 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. — View 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. — View 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. Review. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Slow pathway modification/elimination	Success of the ablation determined at the end of the procedure, defined as slow pathway modification (persistence of AH jump with maximum of 1 echo under Isoprenaline) or elimination (No AH jump; no echo), resulting in arrhythmia non-inducibility	Up to 6 hours	No
Secondary	Time to AVNRT recurrence	Arrhythmia (AVNRT) recurrence evaluation at routine 6-month follow-up visit, defined as: ECG/Holter documented supraventricular regular tachycardia, with/without need for re-intervention.	Up to 6 Months	No
Secondary	High-degree AV block requiring permanent pace-maker	Major adverse event usually occuring during ablation procedure or as late as 48 hours after the procedure	Up to 48 hours	Yes
Secondary	Cardiac tamponade	Major adverse event resulting in significant pericardial effusion with hemodynamic instability (Systolic Blood pressure <90 mmHg), requiring intervention (pericardiocentesis; cardiac surgery)	Up to 48 hours	Yes
Secondary	Systemic embolic events	Major adverse event secondary to systemic thromboembolism resulting in stroke or transient ischemic attack, or peripheral acute ischemia syndrome.	Up to 48 hours	Yes
Secondary	Transient AV conduction disturbance	Minor adverse event resulting in transient prolongation of AV conduction, transient 2nd or 3rd degree AV block.	Up to 48 hours	Yes
Secondary	Peripheral arterio-venous complications	Minor adverse event implicating the site of vascular approach, resulting in local hematoma of the groin or femoral arterio-venous fistula.	Up to 48 hours	Yes
Secondary	Number of Participants with Adverse Events as a Measure of Safety and Tolerability	Composite endpoint for safety using previously stated adverse events: high-degree AV block requiring permanent pace-maker, cardiac tamponade, systemic embolic events, transient AV conduction disturbances, peripheral arterio-venous complications.	Up to 48 hours	Yes