AzTrials
AzTrials

Ventricular TachycardiaEarly Phase 1EPI-VTNCT04512911

Comparison of Ventricular Tachycardia Ablation Strategies in Patients With Ischemic Cardiomyopathy

A Early Phase 1 study testing Endocardial ablation, Endocardial- Epicardial ablation and Antiarrhythmic medications in people with Ventricular Tachycardia, run by Montefiore Medical Center at 1 site in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
Search all trials

Trial summary

This is a prospective multicenter randomized open-label study aiming to assess whether endocardial or endocardial-epicardial ablation is superior to the standard approach (i.e., Antiarrhythmic drugs) in achievement of long-term ventricular tachycardia (VT) treatment success. Read more about this study

Who is it for?
Ages 18 to 99 years
Conditions the study is for
Ventricular Tachycardia
What is being tested?
Endocardial ablation, Endocardial- Epicardial ablation and Antiarrhythmic medications
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
1 siteUnited States
Study dates
Jan 2023to 23 Jan 2023
Phase
Early Phase 1
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 99 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Provision of signed and dated informed consent form
  • Stated willingness to comply with all study procedures and availability for the duration of the study
  • Male or female, aged 18 or greater
  • Patient with ≥ 1 episode of VT (i.e., Sustained VT more than 30 seconds or VT with any ICD therapy)
  • Patients with ischemic cardiomyopathy, EF less than 50%, documented history of CAD

Who cannot join

  • Patients with ventricular fibrillation.
  • Reversible causes of VT.
  • Patients with contraindications to systemic anticoagulation with heparin or coumadin, direct thrombin inhibitor or factor Xa inhibitors.
  • Patients with prior procedure involving opening the pericardium or entering the pericardial space (e.g., CABG, heart transplantation, valve surgery) were adhesions are suspected
  • Any prior ablation for the ventricles or any prior epicardial ablation
  • Documented history of myocardial infarction within 1 month prior to the planned study intervention
Show all 14Show fewer
  • Documented symptomatic carotid disease defined as > 70% stenosis or > 50% stenosis with symptoms
  • Any history of thoracic radiation with the exception of localized radiation treatment for breast cancer
  • Active pericarditis
  • Active endocarditis\Any documented history or autoimmune disease associated with pericarditis
  • Thrombocytopenia (platelet count < 100 x 109/L)
  • Body Mass Index (BMI > 45)
  • Patients who are pregnant.
  • Pregnancy will be assessed by urine pregnancy testing prior to the ablation procedure

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Montefiore Medical Center, Cardiology

    The Bronx, New York, 10467

Other trials in United States

About this study

Official title: Endocardial-Epicardial Radiofrequency Ablation of Ventricular Tachycardia in Patients With Ischemic Cardiomyopathy

This is a prospective multicenter randomized open-label study aiming to assess whether endocardial or endocardial-epicardial ablation is superior to the standard approach (i.e., Antiarrhythmic drugs) in achievement of long-term ventricular tachycardia (VT) treatment success.

Read the detailed description

Comparison of Ventricular Tachycardia Ablation Strategies in Patients With Ischemic Cardiomyopathy (EPI VT) is a prospective multicenter randomized controlled study that is planned as a pilot study to include 100 patients. The aim of our study is to assess whether endocardial or endocardial-epicardial ablation is superior to the standard approach (i.e., Antiarrhythmic drugs) in the achievement of long-term ventricular tachycardia (VT) treatment success. Patients will be stratified into two groups depending on the history of taking antiarrhythmic medications (AAD) and each group will be further randomized 1:1 for endocardial and epicardial ablation vs endocardial only ablation in group who failed AAD. And in the group who didn't fail AADs patients will be randomized 1:1:1 into 3 groups: endocardial and epicardial ablation, endocardial only ablation or antiarrhythmic medications. Follow up planned at 3, 6 and 12 months, if VT recurrence is noted, repeated procedure (according to initially allocated group) or adjustment of medications (if AAD group) will be performed. Follow up at 3, 6 and 12 months is also planned after a repeat procedure/ medications adjustment.

Primary endpoints include freedom from documented VT episodes (> 30 seconds) at 12 months after the first ablation procedure or on antiarrhythmic medication and freedom from documented VT episodes (>30 seconds) at 12 months after the second ablation procedure or on two antiarrhythmics combined.

Being tested
Endocardial ablation, Endocardial- Epicardial ablation, Antiarrhythmic medications
Keywords
Ventricular tachycardia, Catheter ablation, Epicardial ablation, arrhythmia recurrence
Medical subject headings
Tachycardia, Ventricular

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Endocardial ablationProcedure or surgery

    Endocardial ablation of VT

  • Endocardial- Epicardial ablationProcedure or surgery

    Epicardial ablation of VT in addition to endocardial ablation

  • Antiarrhythmic medicationsDrug

    Addition of anti arrhythmic medication or dose increase

Study groups in NCT04512911
Study groupRoleWhat they receive
Patients who didn't fail AADActive comparatorThis group of patients will be randomized to 3 subgroups: 1) Endocardial ablation; 2) Endocardial - Epicardial ablation; 3) Antiarrhythmic medications
Receives: Procedure: Endocardial ablation; Procedure: Endocardial- Epicardial ablation; Drug: Antiarrhythmic medications
Patients who failed AADActive comparatorThis group of patients will be randomized to 2 subgroups: 1) Endocardial ablation; 2) Endocardial - Epicardial ablation
Receives: Procedure: Endocardial ablation; Procedure: Endocardial- Epicardial ablation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Freedom from documented VT episodes

    Freedom from documented VT episodes (greater than 30 seconds) at 12 months after the first ablation procedure or on antiarrhythmic medication.

    Measured: 12 months

  2. Freedom from documented VT episodes after second intervention

    Freedom from documented VT episodes (greater than 30 seconds) at 12 months after the second ablation procedure or on two antiarrhythmics combined.

    Measured: 12 months after second intervention

Secondary outcomes (5)

  1. Incidence of peri-procedural and 12-month post procedural complications,

    These complications include but not limited to ischemic stroke, cardiac perforation, rehospitalization, and death.

    Measured: 12 months

  2. Procedure duration and fluoroscopy time

    Procedure duration and fluoroscopy time

    Measured: Up to 4 hours (During ablation procedure)

  3. Number of repeat procedures

    Number of repeat ablations

    Measured: 12, 24 months

  4. Cost-effectiveness analysis

    The CEA will examine the cost of health care resources and health outcomes from the ablation procedure to 1-year postoperatively. The costs will include all health care utilization during this time. Health care utilization, and associated costs, related to the patients' condition, the procedure and adverse events will be the basis of a sensitivity analysis.

    Measured: 12 months

  5. Long-term follow-up to evaluate freedom of documented VT episodes

    Long-term follow-up at 24 and 60 months to evaluate freedom of documented VT episodes (>30 seconds)

    Measured: 24 and 60 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Aug 2020
  2. Study startJan 2023 (estimated)
  3. Primary completion23 Jan 2023 (estimated)
  4. Study completion23 Jan 2023 (estimated)

Why it stopped: IRB approval expired 1/23/2023 and eclipsed the 6 month institutional window where study can be reinitiated via progress report. No enrollment has taken place.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Early Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
A total of 100 patients will be randomized in 1:1 fashion to investigation arms Endocardial - Epicardial (20 patients) or Endocardial ablation (20 patients) if patients have previously failed AAD and in 1:1:1 fashion randomization to Endocardial - Epicardial ablation (20 patients), Endocardial ablation (20 patients) and AAD (20 patients) if patients have not failed AAD previously. If during follow up VT recurrence occurs, treatment method that patient was assigned to will be considered failed and patients will undergo redo ablation (same as previously assigned to) or if AAD failed patient will be added a second AAD or changed to another AAD. If during follow up after second procedure or adjustment of AAD patient experiences VT recurrence the treatment method will be considered failed.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04512911
Sponsor's protocol ID
2019-10639
Other IDs
2019
Acronym
EPI-VT
Status last verified
Oct 2023
First submitted
11 Aug 2020
Last updated
6 Oct 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Connolly SJ, Hallstrom AP, Cappato R, Schron EB, Kuck KH, Zipes DP, Greene HL, Boczor S, Domanski M, Follmann D, Gent M, Roberts RS. Meta-analysis of the implantable cardioverter defibrillator secondary prevention trials. AVID, CASH and CIDS studies. Antiarrhythmics vs Implantable Defibrillator study. Cardiac Arrest Study Hamburg . Canadian Implantable Defibrillator Study. Eur Heart J. 2000 Dec;21(24):2071-8. doi: 10.1053/euhj.2000.2476.

    PubMed 11102258

  • Poole JE, Johnson GW, Hellkamp AS, Anderson J, Callans DJ, Raitt MH, Reddy RK, Marchlinski FE, Yee R, Guarnieri T, Talajic M, Wilber DJ, Fishbein DP, Packer DL, Mark DB, Lee KL, Bardy GH. Prognostic importance of defibrillator shocks in patients with heart failure. N Engl J Med. 2008 Sep 4;359(10):1009-17. doi: 10.1056/NEJMoa071098.

    PubMed 18768944

  • Tung R, Vaseghi M, Frankel DS, Vergara P, Di Biase L, Nagashima K, Yu R, Vangala S, Tseng CH, Choi EK, Khurshid S, Patel M, Mathuria N, Nakahara S, Tzou WS, Sauer WH, Vakil K, Tedrow U, Burkhardt JD, Tholakanahalli VN, Saliaris A, Dickfeld T, Weiss JP, Bunch TJ, Reddy M, Kanmanthareddy A, Callans DJ, Lakkireddy D, Natale A, Marchlinski F, Stevenson WG, Della Bella P, Shivkumar K. Freedom from recurrent ventricular tachycardia after catheter ablation is associated with improved survival in patients with structural heart disease: An International VT Ablation Center Collaborative Group study. Heart Rhythm. 2015 Sep;12(9):1997-2007. doi: 10.1016/j.hrthm.2015.05.036. Epub 2015 May 30.

    PubMed 26031376

  • Bardy GH, Lee KL, Mark DB, Poole JE, Packer DL, Boineau R, Domanski M, Troutman C, Anderson J, Johnson G, McNulty SE, Clapp-Channing N, Davidson-Ray LD, Fraulo ES, Fishbein DP, Luceri RM, Ip JH; Sudden Cardiac Death in Heart Failure Trial (SCD-HeFT) Investigators. Amiodarone or an implantable cardioverter-defibrillator for congestive heart failure. N Engl J Med. 2005 Jan 20;352(3):225-37. doi: 10.1056/NEJMoa043399.

    PubMed 15659722

  • Sapp JL, Wells GA, Parkash R, Stevenson WG, Blier L, Sarrazin JF, Thibault B, Rivard L, Gula L, Leong-Sit P, Essebag V, Nery PB, Tung SK, Raymond JM, Sterns LD, Veenhuyzen GD, Healey JS, Redfearn D, Roux JF, Tang AS. Ventricular Tachycardia Ablation versus Escalation of Antiarrhythmic Drugs. N Engl J Med. 2016 Jul 14;375(2):111-21. doi: 10.1056/NEJMoa1513614. Epub 2016 May 5.

    PubMed 27149033

  • Romero J, Cerrud-Rodriguez RC, Di Biase L, Diaz JC, Alviz I, Grupposo V, Cerna L, Avendano R, Tedrow U, Natale A, Tung R, Kumar S. Combined Endocardial-Epicardial Versus Endocardial Catheter Ablation Alone for Ventricular Tachycardia in Structural Heart Disease: A Systematic Review and Meta-Analysis. JACC Clin Electrophysiol. 2019 Jan;5(1):13-24. doi: 10.1016/j.jacep.2018.08.010. Epub 2018 Sep 26.

    PubMed 30678778

  • Arenal A, Hernandez J, Calvo D, Ceballos C, Atea L, Datino T, Atienza F, Gonzalez-Torrecilla E, Eidelman G, Miracle A, Avila P, Bermejo J, Fernandez-Aviles F. Safety, long-term results, and predictors of recurrence after complete endocardial ventricular tachycardia substrate ablation in patients with previous myocardial infarction. Am J Cardiol. 2013 Feb 15;111(4):499-505. doi: 10.1016/j.amjcard.2012.10.031. Epub 2012 Dec 8.

    PubMed 23228925

  • Tschabrunn CM, Roujol S, Nezafat R, Faulkner-Jones B, Buxton AE, Josephson ME, Anter E. A swine model of infarct-related reentrant ventricular tachycardia: Electroanatomic, magnetic resonance, and histopathological characterization. Heart Rhythm. 2016 Jan;13(1):262-73. doi: 10.1016/j.hrthm.2015.07.030. Epub 2015 Jul 28.

    PubMed 26226214

  • Acosta J, Fernandez-Armenta J, Penela D, Andreu D, Borras R, Vassanelli F, Korshunov V, Perea RJ, de Caralt TM, Ortiz JT, Fita G, Sitges M, Brugada J, Mont L, Berruezo A. Infarct transmurality as a criterion for first-line endo-epicardial substrate-guided ventricular tachycardia ablation in ischemic cardiomyopathy. Heart Rhythm. 2016 Jan;13(1):85-95. doi: 10.1016/j.hrthm.2015.07.010. Epub 2015 Jul 9.

    PubMed 26165946

  • Arenal A, Perez-David E, Avila P, Fernandez-Portales J, Crisostomo V, Baez C, Jimenez-Candil J, Rubio-Guivernau JL, Ledesma-Carbayo MJ, Loughlin G, Bermejo J, Sanchez-Margallo FM, Fernandez-Aviles F. Noninvasive identification of epicardial ventricular tachycardia substrate by magnetic resonance-based signal intensity mapping. Heart Rhythm. 2014 Aug;11(8):1456-64. doi: 10.1016/j.hrthm.2014.04.022. Epub 2014 Apr 16.

    PubMed 24747421

  • Di Biase L, Santangeli P, Burkhardt DJ, Bai R, Mohanty P, Carbucicchio C, Dello Russo A, Casella M, Mohanty S, Pump A, Hongo R, Beheiry S, Pelargonio G, Santarelli P, Zucchetti M, Horton R, Sanchez JE, Elayi CS, Lakkireddy D, Tondo C, Natale A. Endo-epicardial homogenization of the scar versus limited substrate ablation for the treatment of electrical storms in patients with ischemic cardiomyopathy. J Am Coll Cardiol. 2012 Jul 10;60(2):132-41. doi: 10.1016/j.jacc.2012.03.044.

    PubMed 22766340

  • Pokushalov E, Romanov A, Turov A, Artyomenko S, Shirokova N, Karaskov A. Percutaneous epicardial ablation of ventricular tachycardia after failure of endocardial approach in the pediatric population with arrhythmogenic right ventricular dysplasia. Heart Rhythm. 2010 Oct;7(10):1406-10. doi: 10.1016/j.hrthm.2010.06.020. Epub 2010 Jun 17.

    PubMed 20601157

  • Lunati M, Gasparini M, Bocchiardo M, Curnis A, Landolina M, Carboni A, Luzzi G, Zanotto G, Ravazzi P, Magenta G, Denaro A, Distefano P, Grammatico A; InSync ICD Italian Registry Investigators. Clustering of ventricular tachyarrhythmias in heart failure patients implanted with a biventricular cardioverter defibrillator. J Cardiovasc Electrophysiol. 2006 Dec;17(12):1299-306. doi: 10.1111/j.1540-8167.2006.00618.x.

    PubMed 17239095

  • Dorian P, Borggrefe M, Al-Khalidi HR, Hohnloser SH, Brum JM, Tatla DS, Brachmann J, Myerburg RJ, Cannom DS, van der Laan M, Holroyde MJ, Singer I, Pratt CM; SHock Inhibition Evaluation with azimiLiDe (SHIELD) Investigators. Placebo-controlled, randomized clinical trial of azimilide for prevention of ventricular tachyarrhythmias in patients with an implantable cardioverter defibrillator. Circulation. 2004 Dec 14;110(24):3646-54. doi: 10.1161/01.CIR.0000149240.98971.A8. Epub 2004 Nov 8.

    PubMed 15533855

  • Frankel DS, Mountantonakis SE, Robinson MR, Zado ES, Callans DJ, Marchlinski FE. Ventricular tachycardia ablation remains treatment of last resort in structural heart disease: argument for earlier intervention. J Cardiovasc Electrophysiol. 2011 Oct;22(10):1123-8. doi: 10.1111/j.1540-8167.2011.02081.x. Epub 2011 May 3.

    PubMed 21539642

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing Endocardial ablation, Endocardial- Epicardial ablation and Antiarrhythmic medications in people with Ventricular Tachycardia, run by Montefiore Medical Center at 1 site in United States.

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 5 inclusion and 14 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 6 Oct 2023. 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 United States. 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.

What does this phase mean?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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?

Freedom from documented VT episodes (time frame: 12 months). The study lists 2 primary outcomes in all. 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 NCT04512911, which also lists 39 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 6 Oct 2023.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in