Re-entrant Atrioventricular Node TachycardiaNCT02072473
Safety and Efficacy Aspects of a Standardized Stepwise Anatomical Approach for AVNRT Ablation
An observational study of Re-entrant Atrioventricular Node Tachycardia, run by Sheba Medical Center at 1 site in Israel.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Re-entrant Atrioventricular Node Tachycardia
- What is being tested?
- Coronary sinus / left-sided slow pathway ablation
- Type of treatment
- Surgery or procedure
- How many people
- 0 participants
- Where
- 1 siteIsrael
- Study dates
- Sep 2014to Apr 2016
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Symptomatic AVNRT patients undergoing ablation procedure
Who may be able to join
- 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°
Show all 9Show fewer
- 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)
Who cannot join
- Previous CVA
- Severe mitral or aortic valve disease
- Documented intra-cardiac thrombus
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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:
Read more
- 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.
Read the 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:
- 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.
- Being tested
- Coronary sinus / left-sided slow pathway ablation
- Keywords
- Re-entrant Atrioventricular Node Tachycardia, Unsuccessful right-sided slow pathway ablation, Coronary sinus / left-sided slow pathway ablation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Coronary sinus / left-sided slow pathway ablationProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Coronary sinus / left-sided slow pathway ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Up to 6 hours
Secondary outcomes (7)
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.
Measured: Up to 6 Months
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
Measured: Up to 48 hours
Cardiac tamponade
Major adverse event resulting in significant pericardial effusion with hemodynamic instability (Systolic Blood pressure <90 mmHg), requiring intervention (pericardiocentesis; cardiac surgery)
Measured: Up to 48 hours
Systemic embolic events
Major adverse event secondary to systemic thromboembolism resulting in stroke or transient ischemic attack, or peripheral acute ischemia syndrome.
Measured: Up to 48 hours
Transient AV conduction disturbance
Minor adverse event resulting in transient prolongation of AV conduction, transient 2nd or 3rd degree AV block.
Measured: Up to 48 hours
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.
Measured: Up to 48 hours
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.
Measured: Up to 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2014 (estimated)
- Study startSep 2014
- Primary completionApr 2016
- Study completionApr 2016
Why it stopped: No enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Re-entrant Atrioventricular Node TachycardiaStudies of the same condition, open and under way.
- More trials run by Sheba Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Sheba Medical Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Roy Beinart, MD, Principal investigator, Sheba Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02072473
- Sponsor's protocol ID
- SHEBA-0716-13-RB-CTIL
- Status last verified
- Oct 2016
- First submitted
- 10 Feb 2014
- Last updated
- 19 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 8113554Inoue 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.
PubMed 9445172Kilic 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.
PubMed 16394598Katritsis 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.
PubMed 21153692Lee 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.
PubMed 19225293
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy Aspects of a Standardized Stepwise Anatomical Approach for Atrio-Ventricular Nodal Re-entrant Tachycardia Ablation
- ClinicalTrials.gov ID
- NCT02072473
- Acronym / sponsor ID
- SHEBA-0716-13-RB-CTIL
- Keywords
- Re-entrant Atrioventricular Node Tachycardia, Unsuccessful right-sided slow pathway ablation, Coronary sinus / left-sided slow pathway ablation
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: No enrollment
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Sheba Medical CenterOther government
- Study start
- Sep 2014
- Primary completion
- Apr 2016 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 26 Feb 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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:
- 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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Unsuccessful right-sided AVNRT ablation | – | Procedure: Coronary sinus / left-sided slow pathway ablationPatients with unsuccessful right-sided slow pathway ablation attempt, will be candidates for Coronary sinus / left-sided slow pathway ablation. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Symptomatic AVNRT patients undergoing ablation procedure
Key inclusion criteria (9 listed)
- Age > 18 and <80 years
- History of symptomatic PSVT
- Signed informed consent
- Documented AVNRT during EPS with at least 1 of the following:
Key exclusion criteria (3 listed)
- Previous CVA
- Severe mitral or aortic valve disease
- Documented intra-cardiac thrombus
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Coronary sinus / left-sided slow pathway ablationPatients 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. | Procedure or surgery | Unsuccessful right-sided AVNRT ablation |
Primary outcome
Slow pathway modification/elimination
Time frame: Up to 6 hours
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
7 secondary outcomes
Time to AVNRT recurrence
Time frame: Up to 6 Months
High-degree AV block requiring permanent pace-maker
Time frame: Up to 48 hours
Cardiac tamponade
Time frame: Up to 48 hours
Systemic embolic events
Time frame: Up to 48 hours
Transient AV conduction disturbance
Time frame: Up to 48 hours
Peripheral arterio-venous complications
Time frame: Up to 48 hours
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Time frame: Up to 48 hours
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2016.
- Background: PubMed 8113554McGuire 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.
- Background: PubMed 9445172Inoue 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.
- Background: PubMed 16394598Kilic 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.
- Background: PubMed 21153692Katritsis 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.
- Background: PubMed 19225293Lee 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.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Roy Beinart, MD principal investigator
Sheba Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Re-entrant Atrioventricular Node Tachycardia, run by Sheba Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 19 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Slow pathway modification/elimination (time frame: Up to 6 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02072473, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2016.