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Ventricular TachycardiaNCT03601832

Non-invasive Ablation of Ventricular Tachycardia

A study testing 4-D navigated stereotactic radiosurgical ablation in people with Ventricular Tachycardia, run by University Hospital Ostrava at 3 sites in Czechia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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

Who is it for?
Ages 18 years and older
Conditions the study is for
Ventricular Tachycardia
What is being tested?
4-D navigated stereotactic radiosurgical ablation
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10 participants
Where
3 sitesCzechia
Study dates
1 Aug 2018to 31 Jan 2020
Phase
Interventional
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)
Show all 9Show fewer
  • 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

Who cannot join

  • 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

Trial locations and contacts

3 sites in 1 country.

Czechia3 sites

  • Hospital Nový Jičín, Nuclear Medicine - PET/CT

    Nový Jičín, Moravian-Silesian Region, 741 01

  • University Hospital Ostrava

    Ostrava, Moravian-Silesian Region, 708 52

  • Hospital Podlesí

    Třinec, Moravian-Silesian Region, 739 61

Other trials in Czechia

About this study

Official title: Phase I/II Study of 4-D Navigated Non-invasive Radiosurgical Ablation of Ventricular Tachycardia

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

Read the detailed description

The goal of this project dealing with 4D-navigated substrate ablation is to evaluate the feasibility and safety of elimination of the scar-related monomorphic ventricular tachycardia (VT) or tachycardias by stereotactic radiosurgical ablation that is completely non-invasive. The arrhythmic substrate is defined as the scar after myocardial infarction (MI) described by transthoracic echocardiography (TTE) and specified by PET-CT or MRI. All sustained monomorphic VT induced by programmed ventricular stimulation via implanted ICD (Implantable Cardioverter Defibrillator) will be analyzed using body surface ECG mapping. The target volume for stereotactic radiosurgical ablation (single dose of 25 Gy) will be based on accordance between a post-infarction scar (PET-CT or MRI imaging) and arrhythmic substrate (body surface ECG mapping).

Being tested
4-D navigated stereotactic radiosurgical ablation
Keywords
scar-related, ventricular tachycardia, substrate ablation, stereotactic radiosurgery, functional radiosurgery, 4D navigation
Medical subject headings
Tachycardia, Ventricular

What participants receive

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

  • 4-D navigated stereotactic radiosurgical ablationProcedure or surgery

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

Study groups in NCT03601832
Study groupRoleWhat they receive
4-D navigated stereotactic radiosurgical ablationExperimentalThe patients enroled to this arm of the study will undergo 4-D navigated stereotactic radiosurgical ablation.
Receives: Procedure: 4-D navigated stereotactic radiosurgical ablation

What is being measured

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

  1. 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.

    Measured: 90 days

  2. 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.

    Measured: 18 months

  3. 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.

    Measured: 18 months

Secondary outcomes (7)

  1. Time to death at any time

    Measured: 18 months

  2. Time to arrhythmic storm

    Time to arrhythmic storm (three or more documented episodes of VT within 24 hours) at any time and after 90-day treatment period.

    Measured: 90 days

  3. Time to appropriate ICD shock

    Time to appropriate ICD shock at any time and after 90-day treatment period.

    Measured: 90 days

  4. Time to appropriate antitachycardial pacing by ICD

    Time to appropriate antitachycardial pacing by ICD at any time and after 90-day treatment period.

    Measured: 90 days

  5. Hospitalization due to VT

    Measured: 18 months

  6. Hospitalization due to chronic heart failure

    Measured: 18 months

  7. Quality of life measured with EQ-5D questionnaire

    Quality of life measurement using a standardised tool named EQ-5D. EQ-5D is a standardised instrument in the form of a questionnaire developed by the EuroQol Group as a measure of health-related quality of life that can be used in a wide range of health conditions and treatments. The EQ-5D instrument consists of a descriptive system and the EuroQol-visual analogue scales (EQ VAS). The quality of life is measured in 5 dimensions (mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: no problems, some problems, extreme problems. The higher the score achieved, the higher the quality of life of the patient.

    Measured: 18 months

Timeline

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

  1. First posted26 Jul 2018
  2. Study start1 Aug 2018
  3. Primary completion31 Dec 2019
  4. Study completion31 Jan 2020

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
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
All patients enroled in the study are allocated to one group with 4-D navigated stereotactic radiosurgical ablation.
Masking
None (open label)
Enrolment
10 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03601832
Sponsor's protocol ID
NIRA-VT
Other IDs
18/RVO-FNOs/2018
Status last verified
Dec 2022
First submitted
18 May 2018
Last updated
7 Dec 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

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

  • 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.

    PubMed 11907286

  • 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

  • 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

  • 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.

    PubMed 21147263

  • 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.

    PubMed 23246598

  • 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

  • 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.

    PubMed 22492578

  • 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.

    PubMed 25681389

  • 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.

    PubMed 12493111

  • 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.

    PubMed 19165081

  • 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.

    PubMed 26339857

  • 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.

    PubMed 28167089

  • 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.

    PubMed 29236642

Questions about this trial

What is this clinical trial studying?

A study testing 4-D navigated stereotactic radiosurgical ablation in people with Ventricular Tachycardia, run by University Hospital Ostrava at 3 sites in Czechia.

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 7 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: finished, as of the sponsor's last update on 7 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Czechia. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Composite of death (time frame: 90 days). The study lists 3 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 NCT03601832, which also lists 14 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 7 Dec 2022.

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