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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

Status
Withdrawn
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02072473
Enrollment
0
Registered
2014-02-26
Start date
2014-09-30
Completion date
2016-04-30
Last updated
2016-10-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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

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.

Interventions

PROCEDURECoronary sinus / left-sided slow pathway ablation

Patients with unsuccessful right-sided slow pathway ablation attempt will undergo a stepwise: 1. coronary sinus slow pathway ablation, which, if unsuccessful, will be followed by 2. left-sided slow pathway ablation, using trans-septal approach.

Sponsors

Sheba Medical Center
Lead SponsorOTHER_GOV

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Slow pathway modification/eliminationUp to 6 hoursSuccess 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

Secondary

MeasureTime frameDescription
High-degree AV block requiring permanent pace-makerUp to 48 hoursMajor adverse event usually occuring during ablation procedure or as late as 48 hours after the procedure
Cardiac tamponadeUp to 48 hoursMajor adverse event resulting in significant pericardial effusion with hemodynamic instability (Systolic Blood pressure \<90 mmHg), requiring intervention (pericardiocentesis; cardiac surgery)
Systemic embolic eventsUp to 48 hoursMajor adverse event secondary to systemic thromboembolism resulting in stroke or transient ischemic attack, or peripheral acute ischemia syndrome.
Time to AVNRT recurrenceUp to 6 MonthsArrhythmia (AVNRT) recurrence evaluation at routine 6-month follow-up visit, defined as: ECG/Holter documented supraventricular regular tachycardia, with/without need for re-intervention.
Peripheral arterio-venous complicationsUp to 48 hoursMinor adverse event implicating the site of vascular approach, resulting in local hematoma of the groin or femoral arterio-venous fistula.
Number of Participants with Adverse Events as a Measure of Safety and TolerabilityUp to 48 hoursComposite 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.
Transient AV conduction disturbanceUp to 48 hoursMinor adverse event resulting in transient prolongation of AV conduction, transient 2nd or 3rd degree AV block.

Countries

Israel

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026