- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02072473
Safety and Efficacy Aspects of a Standardized Stepwise Anatomical Approach for AVNRT Ablation
Safety and Efficacy Aspects of a Standardized Stepwise Anatomical Approach for Atrio-Ventricular Nodal Re-entrant Tachycardia Ablation
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:
- Right-side postero-septal tricuspid annulus
- Coronary sinus
- 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.
Study Overview
Status
Conditions
Intervention / Treatment
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:
- Right-side postero-septal tricuspid annulus
- Coronary sinus
- 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.
Study Type
Contacts and Locations
Study Locations
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Ramat Gan, Israel, 52621
- Sheba Medical Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Age > 18 and <80 years
- History of symptomatic PSVT
- Signed informed consent
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 Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
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Unsuccessful right-sided AVNRT ablation
Patients with unsuccessful right-sided slow pathway ablation attempt, will be candidates for Coronary sinus / left-sided slow pathway ablation.
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Patients with unsuccessful right-sided slow pathway ablation attempt will undergo a stepwise:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Slow pathway modification/elimination
Time Frame: Up to 6 hours
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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
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Up to 6 hours
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Time to AVNRT recurrence
Time Frame: Up to 6 Months
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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.
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Up to 6 Months
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High-degree AV block requiring permanent pace-maker
Time Frame: Up to 48 hours
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Major adverse event usually occuring during ablation procedure or as late as 48 hours after the procedure
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Up to 48 hours
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Cardiac tamponade
Time Frame: Up to 48 hours
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Major adverse event resulting in significant pericardial effusion with hemodynamic instability (Systolic Blood pressure <90 mmHg), requiring intervention (pericardiocentesis; cardiac surgery)
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Up to 48 hours
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Systemic embolic events
Time Frame: Up to 48 hours
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Major adverse event secondary to systemic thromboembolism resulting in stroke or transient ischemic attack, or peripheral acute ischemia syndrome.
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Up to 48 hours
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Transient AV conduction disturbance
Time Frame: Up to 48 hours
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Minor adverse event resulting in transient prolongation of AV conduction, transient 2nd or 3rd degree AV block.
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Up to 48 hours
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Peripheral arterio-venous complications
Time Frame: Up to 48 hours
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Minor adverse event implicating the site of vascular approach, resulting in local hematoma of the groin or femoral arterio-venous fistula.
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Up to 48 hours
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Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Time Frame: Up to 48 hours
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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.
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Up to 48 hours
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Roy Beinart, MD, Sheba Medical Center
Publications and helpful links
General Publications
- 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.
- 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.
- 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. Erratum In: Circulation 1998 Mar 31;97(12):1216.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- SHEBA-0716-13-RB-CTIL
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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