Back to resultsSTereotactic Ablative Radiosurgery of Recurrent Ventricular Tachycardia in Structural Heart Disease
Primary Purpose
Ventricular Tachycardia
Status
Completed
Phase
Not Applicable
Locations
Czechia
Study Type
Interventional
Intervention
Radiosurgery
Repeated catheter ablation
Sponsored by
About this trial
This is an interventional treatment trial for Ventricular Tachycardia focused on measuring Structural Heart Disease, Ventricular Tachycardia, Substrate Ablation, Stereotactic Radiosurgery, Functional Radiosurgery, 4D navigation
Eligibility Criteria
Inclusion Criteria:
- Patients with structural heart disease (SHD) of any etiology (ischemic, non-ischemic, congenital corrected or uncorrected)
- Implanted implantable cardioverter-defibrillator (ICD) or cardiac resynchronization therapy-defibrillator (CRT-D)
Prior ≥1 catheter ablation procedure for VT due to SHD of them the last one performed in the expert center and employed:
3.1 all meaningful mapping/ablation approaches (endocardial/epicardial access to left / right ventricular substrate as possible or appropriate) 3.2 precise electroanatomical mapping of the arrhythmogenic substrate in anticipation of future radiosurgery 3.3 additional mapping of structures used for precise image integration (aortic arch, left main ostium, right ventricular endocardial surface)
VT recurrence after the last catheter ablation fulfilling all criteria as follows:
4.1 clinically relevant and requiring further intervention 4.2 compatible with the previously characterized arrhythmogenic substrate 4.3 occurred on stable antiarrhythmic medication (mostly amiodarone) unless contraindicated 4.4 reversible cause excluded
- Signed an Institutional Review Board (IRB)-approved written informed consent
Exclusion Criteria:
- Age < 20 years
- Acute coronary syndrome or recent percutaneous coronary intervention or cardiac surgery (< 3 months)
- Primary electrical disease (channelopathy)
- Pregnancy or breastfeeding
- Chronic heart failure with New York Heart Association (NYHA) Class IV
- Serious comorbidities with presumed life expectancy less than one year
- Significant peripheral artery disease precluding retrograde aortic mapping
Sites / Locations
- Hospital Podlesí
- Institute for Clinical and Experimental Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Radiosurgery
Repeated catheter ablation
Arm Description
Eligible patients will be assigned to 2 treatment arms - radiosurgery (active arm) or repeated catheter ablation (control arm) in 1:1 fashion by covariate-adaptive randomization algorithm considering age, gender, etiology of SHD, LV ejection fraction, and serum NT-proBNP level.
Eligible patients will be assigned to 2 treatment arms - radiosurgery (active arm) or repeated catheter ablation (control arm) in 1:1 fashion by covariate-adaptive randomization algorithm considering age, gender, etiology of SHD, LV ejection fraction, and serum NT-proBNP level.
Outcomes
Primary Outcome Measures
Recurrence of sustained VT after 3-month blanking period
Recurrence of sustained VT after 3-month blanking period will be assessed.
Secondary Outcome Measures
VT burden according to implantable device
Number of sustained VT burden in three 3-month intervals after radiosurgery will be assessed.
Non-inducibility of VT at 6 months
TRUE/FALSE - Pacing protocol will be using 2 basic cycle length drives (600 and 400 ms) and 1-3 extrastimuli with coupling intervals decremented by 10 ms up to the refractoriness or 200 ms.
Recurrence of sustained VT excluding antitachycardia-pacing (ATP)-treated episodes
Recurrence of sustained VT excluding ATP-treated episodes will be assessed.
Electric storm recurrence
The recurrence of electric storm will be observed.
Cardiovascular hospitalization
The number of hospitalisations due to cardiovascular indications will be observed.
All-cause death
The all-cause death will be observed.
Change in quality of life: EQ-5D
Change in quality of life will be observed using the standardised EQ-5D (5-dimension) questionnaire. 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 quality of life is assessed in five dimensions, with three levels in each dimension. The higher score the patient achieves, the better the quality of life.
Change in echocardiographic indices
Left vetricle ejection fraction (%) will be observed.
Rate of major procedure-related complications (control arm)
The rate of major procedure-related complications will be observed among the study subjects enrolled to the control arm of the study, according to the Common Terminology Criteria for Adverse Events (CTCAE, version 5.0).
Rate of acute post-radiation complications (intervention arm)
The rate of acute post-radiation complications will be observed among the study subjects enrolled to the intervention arm of the study, according to the Common Terminology Criteria for Adverse Events (CTCAE, version 5.0)
Extent of scar
The extent of scar will be assessed 6 months after radiosurgery, based on invasive electroanatomical mapping.
Rate of late radiation-induced events
The rate of late radiation-induced events will be assessed according to CTCAE 5.0 in each cohort of isodose line level, specifically, rate of radiation myocarditis, pericarditis, and pneumonitis.
Radiation dose
The radiation dose will be observed for each interventional procedure, CT imaging and radiosurgery, together with the cumulative dose.
Need of antiemetic drugs
The need of antiemetic drugs will be assessed in all study subjects.
Dynamics of serum troponin level
The dynamics of serum troponin level will be observed in all study subjects.
Full Information
NCT ID
NCT04612140
First Posted
October 5, 2020
Last Updated
September 8, 2023
Sponsor
University Hospital Ostrava
Collaborators
Institute for Clinical and Experimental Medicine, Hospital Podlesi
1. Study Identification
Unique Protocol Identification Number
NCT04612140
Brief Title
STereotactic Ablative Radiosurgery of Recurrent Ventricular Tachycardia in Structural Heart Disease
Official Title
STereotactic Ablative Radiosurgery of Recurrent Ventricular Tachycardia in Structural Heart Disease
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
October 1, 2020 (Actual)
Primary Completion Date
December 31, 2022 (Actual)
Study Completion Date
December 31, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital Ostrava
Collaborators
Institute for Clinical and Experimental Medicine, Hospital Podlesi
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
A multicentre trial on clinical effects of radiosurgical ablation of ventricular tachycardia (VT).
Detailed Description
Patients with previously failed conventional RF catheter ablation will be randomized to radiosurgery (active treatment group) or repeated catheter ablation (control treatment group). Details on inclusion and exclusion criteria are provided below.
Randomization Eligible patients will be assigned to 2 treatment arms - radiosurgery (active arm) or repeated catheter ablation (control arm) in 1:1 fashion by covariate-adaptive randomization algorithm considering age, gender, etiology of structural heart disease (SHD), left ventricular (LV) ejection fraction, and serum B-type natriuretic peptide (NT-proBNP) level.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ventricular Tachycardia
Keywords
Structural Heart Disease, Ventricular Tachycardia, Substrate Ablation, Stereotactic Radiosurgery, Functional Radiosurgery, 4D navigation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
The study subjects will be randomized into one of the two study arms.
Masking
None (Open Label)
Masking Description
No masking will be used in the study.
Allocation
Randomized
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Radiosurgery
Arm Type
Experimental
Arm Description
Eligible patients will be assigned to 2 treatment arms - radiosurgery (active arm) or repeated catheter ablation (control arm) in 1:1 fashion by covariate-adaptive randomization algorithm considering age, gender, etiology of SHD, LV ejection fraction, and serum NT-proBNP level.
Arm Title
Repeated catheter ablation
Arm Type
Active Comparator
Arm Description
Eligible patients will be assigned to 2 treatment arms - radiosurgery (active arm) or repeated catheter ablation (control arm) in 1:1 fashion by covariate-adaptive randomization algorithm considering age, gender, etiology of SHD, LV ejection fraction, and serum NT-proBNP level.
Intervention Type
Procedure
Intervention Name(s)
Radiosurgery
Intervention Description
The study subjects randomized in this study arm will undergo a radiosurgery procedure.
Intervention Type
Procedure
Intervention Name(s)
Repeated catheter ablation
Intervention Description
The study subjects randomized in this study arm will undergo repeated catheter ablation.
Primary Outcome Measure Information:
Title
Recurrence of sustained VT after 3-month blanking period
Description
Recurrence of sustained VT after 3-month blanking period will be assessed.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
VT burden according to implantable device
Description
Number of sustained VT burden in three 3-month intervals after radiosurgery will be assessed.
Time Frame
3 months
Title
Non-inducibility of VT at 6 months
Description
TRUE/FALSE - Pacing protocol will be using 2 basic cycle length drives (600 and 400 ms) and 1-3 extrastimuli with coupling intervals decremented by 10 ms up to the refractoriness or 200 ms.
Time Frame
6 months
Title
Recurrence of sustained VT excluding antitachycardia-pacing (ATP)-treated episodes
Description
Recurrence of sustained VT excluding ATP-treated episodes will be assessed.
Time Frame
24 months
Title
Electric storm recurrence
Description
The recurrence of electric storm will be observed.
Time Frame
24 months
Title
Cardiovascular hospitalization
Description
The number of hospitalisations due to cardiovascular indications will be observed.
Time Frame
24 months
Title
All-cause death
Description
The all-cause death will be observed.
Time Frame
24 months
Title
Change in quality of life: EQ-5D
Description
Change in quality of life will be observed using the standardised EQ-5D (5-dimension) questionnaire. 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 quality of life is assessed in five dimensions, with three levels in each dimension. The higher score the patient achieves, the better the quality of life.
Time Frame
24 months
Title
Change in echocardiographic indices
Description
Left vetricle ejection fraction (%) will be observed.
Time Frame
24 months
Title
Rate of major procedure-related complications (control arm)
Description
The rate of major procedure-related complications will be observed among the study subjects enrolled to the control arm of the study, according to the Common Terminology Criteria for Adverse Events (CTCAE, version 5.0).
Time Frame
24 months
Title
Rate of acute post-radiation complications (intervention arm)
Description
The rate of acute post-radiation complications will be observed among the study subjects enrolled to the intervention arm of the study, according to the Common Terminology Criteria for Adverse Events (CTCAE, version 5.0)
Time Frame
24 months
Title
Extent of scar
Description
The extent of scar will be assessed 6 months after radiosurgery, based on invasive electroanatomical mapping.
Time Frame
6 months
Title
Rate of late radiation-induced events
Description
The rate of late radiation-induced events will be assessed according to CTCAE 5.0 in each cohort of isodose line level, specifically, rate of radiation myocarditis, pericarditis, and pneumonitis.
Time Frame
24 months
Title
Radiation dose
Description
The radiation dose will be observed for each interventional procedure, CT imaging and radiosurgery, together with the cumulative dose.
Time Frame
24 months
Title
Need of antiemetic drugs
Description
The need of antiemetic drugs will be assessed in all study subjects.
Time Frame
24 months
Title
Dynamics of serum troponin level
Description
The dynamics of serum troponin level will be observed in all study subjects.
Time Frame
24 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients with structural heart disease (SHD) of any etiology (ischemic, non-ischemic, congenital corrected or uncorrected)
Implanted implantable cardioverter-defibrillator (ICD) or cardiac resynchronization therapy-defibrillator (CRT-D)
Prior ≥1 catheter ablation procedure for VT due to SHD of them the last one performed in the expert center and employed:
3.1 all meaningful mapping/ablation approaches (endocardial/epicardial access to left / right ventricular substrate as possible or appropriate) 3.2 precise electroanatomical mapping of the arrhythmogenic substrate in anticipation of future radiosurgery 3.3 additional mapping of structures used for precise image integration (aortic arch, left main ostium, right ventricular endocardial surface)
VT recurrence after the last catheter ablation fulfilling all criteria as follows:
4.1 clinically relevant and requiring further intervention 4.2 compatible with the previously characterized arrhythmogenic substrate 4.3 occurred on stable antiarrhythmic medication (mostly amiodarone) unless contraindicated 4.4 reversible cause excluded
Signed an Institutional Review Board (IRB)-approved written informed consent
Exclusion Criteria:
Age < 20 years
Acute coronary syndrome or recent percutaneous coronary intervention or cardiac surgery (< 3 months)
Primary electrical disease (channelopathy)
Pregnancy or breastfeeding
Chronic heart failure with New York Heart Association (NYHA) Class IV
Serious comorbidities with presumed life expectancy less than one year
Significant peripheral artery disease precluding retrograde aortic mapping
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jakub Cvek, Ass.Prof.,MD,Ing, PhD,MBA
Organizational Affiliation
University Hospital Ostrava
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Podlesí
City
Třinec
State/Province
Moravian-Silesian Region
ZIP/Postal Code
73961
Country
Czechia
Facility Name
Institute for Clinical and Experimental Medicine
City
Praha
ZIP/Postal Code
14021
Country
Czechia
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
There is no plan to make individual participant data available to other researchers, these may be made available upon request.
Citations:
PubMed Identifier
11102258
Citation
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.
Results Reference
background
PubMed Identifier
11907286
Citation
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.
Results Reference
background
PubMed Identifier
16403928
Citation
Connolly SJ, Dorian P, Roberts RS, Gent M, Bailin S, Fain ES, Thorpe K, Champagne J, Talajic M, Coutu B, Gronefeld GC, Hohnloser SH; Optimal Pharmacological Therapy in Cardioverter Defibrillator Patients (OPTIC) Investigators. Comparison of beta-blockers, amiodarone plus beta-blockers, or sotalol for prevention of shocks from implantable cardioverter defibrillators: the OPTIC Study: a randomized trial. JAMA. 2006 Jan 11;295(2):165-71. doi: 10.1001/jama.295.2.165.
Results Reference
background
PubMed Identifier
23131066
Citation
Moss AJ, Schuger C, Beck CA, Brown MW, Cannom DS, Daubert JP, Estes NA 3rd, Greenberg H, Hall WJ, Huang DT, Kautzner J, Klein H, McNitt S, Olshansky B, Shoda M, Wilber D, Zareba W; MADIT-RIT Trial Investigators. Reduction in inappropriate therapy and mortality through ICD programming. N Engl J Med. 2012 Dec 13;367(24):2275-83. doi: 10.1056/NEJMoa1211107. Epub 2012 Nov 6.
Results Reference
background
PubMed Identifier
21147263
Citation
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.
Results Reference
background
PubMed Identifier
27149033
Citation
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.
Results Reference
background
PubMed Identifier
28187168
Citation
Aldhoon B, Wichterle D, Peichl P, Cihak R, Kautzner J. Outcomes of ventricular tachycardia ablation in patients with structural heart disease: The impact of electrical storm. PLoS One. 2017 Feb 10;12(2):e0171830. doi: 10.1371/journal.pone.0171830. eCollection 2017.
Results Reference
background
PubMed Identifier
19348944
Citation
Raymond JM, Sacher F, Winslow R, Tedrow U, Stevenson WG. Catheter ablation for scar-related ventricular tachycardias. Curr Probl Cardiol. 2009 May;34(5):225-70. doi: 10.1016/j.cpcardiol.2009.01.002.
Results Reference
background
PubMed Identifier
27574120
Citation
Kumar S, Baldinger SH, Romero J, Fujii A, Mahida SN, Tedrow UB, Stevenson WG. Substrate-Based Ablation Versus Ablation Guided by Activation and Entrainment Mapping for Ventricular Tachycardia: A Systematic Review and Meta-Analysis. J Cardiovasc Electrophysiol. 2016 Dec;27(12):1437-1447. doi: 10.1111/jce.13088. Epub 2016 Oct 6.
Results Reference
background
PubMed Identifier
22492578
Citation
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.
Results Reference
background
PubMed Identifier
22766340
Citation
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.
Results Reference
background
PubMed Identifier
25681389
Citation
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.
Results Reference
background
PubMed Identifier
23246598
Citation
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.
Results Reference
background
PubMed Identifier
23727700
Citation
Tokuda M, Kojodjojo P, Tung S, Tedrow UB, Nof E, Inada K, Koplan BA, Michaud GF, John RM, Epstein LM, Stevenson WG. Acute failure of catheter ablation for ventricular tachycardia due to structural heart disease: causes and significance. J Am Heart Assoc. 2013 May 31;2(3):e000072. doi: 10.1161/JAHA.113.000072.
Results Reference
background
PubMed Identifier
26082532
Citation
Loo BW Jr, Soltys SG, Wang L, Lo A, Fahimian BP, Iagaru A, Norton L, Shan X, Gardner E, Fogarty T, Maguire P, Al-Ahmad A, Zei P. Stereotactic ablative radiotherapy for the treatment of refractory cardiac ventricular arrhythmia. Circ Arrhythm Electrophysiol. 2015 Jun;8(3):748-50. doi: 10.1161/CIRCEP.115.002765. No abstract available.
Results Reference
background
PubMed Identifier
29236642
Citation
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.
Results Reference
background
PubMed Identifier
30586734
Citation
Robinson CG, Samson PP, Moore KMS, Hugo GD, Knutson N, Mutic S, Goddu SM, Lang A, Cooper DH, Faddis M, Noheria A, Smith TW, Woodard PK, Gropler RJ, Hallahan DE, Rudy Y, Cuculich PS. Phase I/II Trial of Electrophysiology-Guided Noninvasive Cardiac Radioablation for Ventricular Tachycardia. Circulation. 2019 Jan 15;139(3):313-321. doi: 10.1161/CIRCULATIONAHA.118.038261.
Results Reference
background
PubMed Identifier
29753550
Citation
Jumeau R, Ozsahin M, Schwitter J, Vallet V, Duclos F, Zeverino M, Moeckli R, Pruvot E, Bourhis J. Rescue procedure for an electrical storm using robotic non-invasive cardiac radio-ablation. Radiother Oncol. 2018 Aug;128(2):189-191. doi: 10.1016/j.radonc.2018.04.025. Epub 2018 May 9.
Results Reference
background
PubMed Identifier
30693205
Citation
Haskova J, Peichl P, Pirk J, Cvek J, Neuwirth R, Kautzner J. Stereotactic radiosurgery as a treatment for recurrent ventricular tachycardia associated with cardiac fibroma. HeartRhythm Case Rep. 2018 Oct 24;5(1):44-47. doi: 10.1016/j.hrcr.2018.10.007. eCollection 2019 Jan. No abstract available.
Results Reference
background
PubMed Identifier
31121018
Citation
Neuwirth R, Cvek J, Knybel L, Jiravsky O, Molenda L, Kodaj M, Fiala M, Peichl P, Feltl D, Januska J, Hecko J, Kautzner J. Stereotactic radiosurgery for ablation of ventricular tachycardia. Europace. 2019 Jul 1;21(7):1088-1095. doi: 10.1093/europace/euz133.
Results Reference
background
Learn more about this trial
STereotactic Ablative Radiosurgery of Recurrent Ventricular Tachycardia in Structural Heart Disease
We'll reach out to this number within 24 hrs