Non-invasive Ablation of Ventricular Tachycardia

NCT03601832 | Completed

• 2 other identifiers: NIRA-VT18/RVO-FNOs/2018
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 3

Brief Summary

Phase I/II study of 4-D Navigated Non-invasive radiosurgical ablation of ventricular tachycardia (NIRA-VT).

Conditions

Ventricular Tachycardia

Keywords

scar-related; ventricular tachycardia; substrate ablation; stereotactic radiosurgery; functional radiosurgery; 4D navigation

Outcome Measures

Primary Outcomes (3)

• Composite of death

  Composite of death occurring at any time after treatment or arrhythmic storm (three or more documented episodes of VT within 24 hours) or appropriate ICD therapy (both shock and pacing) after a 90-day treatment period. 90-day treatment period was imposed to exclude nonfatal outcomes that might occur during acute radiation reaction. Moreover, functional radiosurgery has 90% success rate after 3 months.

  90 days

• Acute radiation-induced events

  Acute radiation-induced events (within 3 months after treatment) according to CTCAE 4.0. Major concern will be on radiation myocarditis, pericarditis and pneumonitis/fibrosis. Needs of antiemetic drugs will be recorded.

  18 months

• Late radiation-induced effects

  Late radiation-induced effects (after 3 months after treatment) according to CTCAE 4.0. Major concern will be on radiation myocarditis, pericarditis and pneumonitis/fibrosis. Needs of antiemetic drugs will be recorded.

  18 months

Secondary Outcomes (7)

• Time to death at any time

  18 months

• Time to arrhythmic storm

  90 days

• Time to appropriate ICD shock

  90 days

• Time to appropriate antitachycardial pacing by ICD

  90 days

• Hospitalization due to VT

  18 months

Study Arms (1)

4-D navigated stereotactic radiosurgical ablation

EXPERIMENTAL

The patients enroled to this arm of the study will undergo 4-D navigated stereotactic radiosurgical ablation.

Procedure: 4-D navigated stereotactic radiosurgical ablation

Interventions

4-D navigated stereotactic radiosurgical ablation PROCEDURE

4-D Navigated Non-invasive radiosurgical ablation of ventricular tachycardia in patients with sustained monomorphic ventricular tachycardia/tachycardias after myocardial infarction.

4-D navigated stereotactic radiosurgical ablation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• history of sustained monomorphic VT or termination of monomorphic VT by ICD (appropriate therapy) during previous 6 months prior to enrollment
• implantation ICD
• inducibility at least one of monomorphic ventricular tachycardia by ICD during EP study with programmed ventricular stimulation
• history of myocardial infarction (MI)
• left ventricular scar and decreased systolic function of the left ventricle (ejection fraction of left ventricle less than 40%) based on transthoracic ultrasound
• stable chronic heart failure (NYHA II-III)
• older than 18 years
• signed an IRB approved written informed consent document.
• failed at least one invasive catheter ablation procedure or have a contraindication to a catheter ablation procedure

You may not qualify if:

• acute myocardial infarction
• chronic heart failure NYHA IV
• channelopathy
• reversible cause of VT (e.g. ionic dysbalance, intoxications)
• pregnancy or breastfeeding
• history of chest radiotherapy
• arrhythmic substrate larger than 100 ccm

Sponsors & Collaborators

• University Hospital Ostrava: lead
• University of Ostrava: collaborator
• Hospital Podlesi: collaborator
• Hospital Nový Jičín: collaborator

Study Sites (3)

Hospital Nový Jičín, Nuclear Medicine - PET/CT

Nový Jičín, Moravian-Silesian Region, 741 01, Czechia

Location

University Hospital Ostrava

Ostrava, Moravian-Silesian Region, 708 52, Czechia

Location

Hospital Podlesí

Třinec, Moravian-Silesian Region, 739 61, Czechia

Location

Related Publications (14)

• 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.

  PMID: 11102258 BACKGROUND

• Moss AJ, Zareba W, Hall WJ, Klein H, Wilber DJ, Cannom DS, Daubert JP, Higgins SL, Brown MW, Andrews ML; Multicenter Automatic Defibrillator Implantation Trial II Investigators. Prophylactic implantation of a defibrillator in patients with myocardial infarction and reduced ejection fraction. N Engl J Med. 2002 Mar 21;346(12):877-83. doi: 10.1056/NEJMoa013474. Epub 2002 Mar 19.

  PMID: 11907286 BACKGROUND

• 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.

  PMID: 18768944 BACKGROUND

• 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.

  PMID: 27149033 BACKGROUND

• Mallidi J, Nadkarni GN, Berger RD, Calkins H, Nazarian S. Meta-analysis of catheter ablation as an adjunct to medical therapy for treatment of ventricular tachycardia in patients with structural heart disease. Heart Rhythm. 2011 Apr;8(4):503-10. doi: 10.1016/j.hrthm.2010.12.015. Epub 2010 Dec 13.

  PMID: 21147263 BACKGROUND

• Tung R, Michowitz Y, Yu R, Mathuria N, Vaseghi M, Buch E, Bradfield J, Fujimura O, Gima J, Discepolo W, Mandapati R, Shivkumar K. Epicardial ablation of ventricular tachycardia: an institutional experience of safety and efficacy. Heart Rhythm. 2013 Apr;10(4):490-8. doi: 10.1016/j.hrthm.2012.12.013. Epub 2012 Dec 11.

  PMID: 23246598 BACKGROUND

• 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.

  PMID: 22766340 BACKGROUND

• Jais P, Maury P, Khairy P, Sacher F, Nault I, Komatsu Y, Hocini M, Forclaz A, Jadidi AS, Weerasooryia R, Shah A, Derval N, Cochet H, Knecht S, Miyazaki S, Linton N, Rivard L, Wright M, Wilton SB, Scherr D, Pascale P, Roten L, Pederson M, Bordachar P, Laurent F, Kim SJ, Ritter P, Clementy J, Haissaguerre M. Elimination of local abnormal ventricular activities: a new end point for substrate modification in patients with scar-related ventricular tachycardia. Circulation. 2012 May 8;125(18):2184-96. doi: 10.1161/CIRCULATIONAHA.111.043216. Epub 2012 Apr 4.

  PMID: 22492578 BACKGROUND

• Tzou WS, Frankel DS, Hegeman T, Supple GE, Garcia FC, Santangeli P, Katz DF, Sauer WH, Marchlinski FE. Core isolation of critical arrhythmia elements for treatment of multiple scar-based ventricular tachycardias. Circ Arrhythm Electrophysiol. 2015 Apr;8(2):353-61. doi: 10.1161/CIRCEP.114.002310. Epub 2015 Feb 13.

  PMID: 25681389 BACKGROUND

• Chang SD, Main W, Martin DP, Gibbs IC, Heilbrun MP. An analysis of the accuracy of the CyberKnife: a robotic frameless stereotactic radiosurgical system. Neurosurgery. 2003 Jan;52(1):140-6; discussion 146-7. doi: 10.1097/00006123-200301000-00018.

  PMID: 12493111 BACKGROUND

• Fariselli L, Marras C, De Santis M, Marchetti M, Milanesi I, Broggi G. CyberKnife radiosurgery as a first treatment for idiopathic trigeminal neuralgia. Neurosurgery. 2009 Feb;64(2 Suppl):A96-101. doi: 10.1227/01.NEU.0000341714.55023.8F.

  PMID: 19165081 BACKGROUND

• Regis J, Tuleasca C, Resseguier N, Carron R, Donnet A, Gaudart J, Levivier M. Long-term safety and efficacy of Gamma Knife surgery in classical trigeminal neuralgia: a 497-patient historical cohort study. J Neurosurg. 2016 Apr;124(4):1079-87. doi: 10.3171/2015.2.JNS142144. Epub 2015 Sep 4.

  PMID: 26339857 BACKGROUND

• Gianni C, Mohanty S, Trivedi C, Di Biase L, Al-Ahmad A, Natale A, David Burkhardt J. Alternative Approaches for Ablation of Resistant Ventricular Tachycardia. Card Electrophysiol Clin. 2017 Mar;9(1):93-98. doi: 10.1016/j.ccep.2016.10.006. Epub 2016 Dec 24.

  PMID: 28167089 BACKGROUND

• Cuculich PS, Schill MR, Kashani R, Mutic S, Lang A, Cooper D, Faddis M, Gleva M, Noheria A, Smith TW, Hallahan D, Rudy Y, Robinson CG. Noninvasive Cardiac Radiation for Ablation of Ventricular Tachycardia. N Engl J Med. 2017 Dec 14;377(24):2325-2336. doi: 10.1056/NEJMoa1613773.

  PMID: 29236642 BACKGROUND

MeSH Terms

Conditions

Tachycardia, Ventricular

Condition Hierarchy (Ancestors)

Tachycardia; Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Cardiac Conduction System Disease; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Jakub Cvek, Ing.,MD,Ph.D.

  University Hospital Ostrava

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: No masking in this study.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: All patients enroled in the study are allocated to one group with 4-D navigated stereotactic radiosurgical ablation.

Study Record Dates

• First Submitted: May 18, 2018
• First Posted: July 26, 2018
• Study Start: August 1, 2018
• Primary Completion: December 31, 2019
• Study Completion: January 31, 2020
• Last Updated: December 7, 2022

Record last verified: 2022-12

Locations

CZ (3)