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Stereotactic Management of Arrhythmia - Radiosurgery in Treatment of Ventricular Tachycardia (SMART-VT)

Primary Purpose

Ventricular Tachycardia

Status
Completed
Phase
Not Applicable
Locations
Poland
Study Type
Interventional
Intervention
Cardiac Radiosurgery
Sponsored by
Maria Sklodowska-Curie National Research Institute of Oncology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ventricular Tachycardia focused on measuring Ventricular Tachycardia, Ablation, Noninvasive, Stereotactic Body Radiation Therapy, Radiosurgery, Substrate Ablation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients with structural heart disease and implantable cardioverter defibrillator (ICD)
  • Clinically significant arrhythmia with at least 3 VT episodes per month despite adequate pharmacological treatment.
  • At least one episode of monomorphic VT registered in electrophysiological examination.
  • Recurrent VT despite at least one prior catheter ablation and adequate pharmacotherapy OR contraindications to catheter ablation and/or pharmacotherapy (i.e., patient with medically contraindicated catheter ablation is obliged to undergo only pharmacotherapy prior to study enrollment).
  • Patient must be able to understand and be willing to sign a written informed consent document.

Exclusion Criteria:

  • Heart failure requiring inotropic treatment or mechanical assistance
  • Arrhythmia due to cardiac channelopathy
  • Reversible source of arrhythmia
  • NYHA (New York Heart Association) stage IV hearth failure
  • Hearth infarction or cardiac surgery in last 3 months
  • Life expectancy <6 months
  • Polymorphic VT
  • Pregnancy
  • Prior radiotherapy to the thoracic region (relative contraindication)
  • Failure to induce VT during electrophysiological examination

Sites / Locations

  • Upper Silesian Medical Center Professor Leszek Giec of the Medical University of Silesia in Katowice
  • Maria Sklodowska-Curie National Research Institute of Oncology (MSCNRIO), Gliwice branch

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Cardiac Radiosurgery

Arm Description

Patients with ventricular tachycardia will undergo a non-invasive cardiac radiosurgery using one fraction of 25 Gy to the arrhythmia substrate, as determined by the electrophysiological cardiac mapping.

Outcomes

Primary Outcome Measures

Acute toxicity evaluated using CTCAE v5.0 scale
The study aims to demonstrate the safety of the treatment method defined as 3-month observation without Grade III or higher adverse events in at least 6 out of 7 patients (1st stage), and in total in at least 9 out of 11 patients (2nd stage) with an interim safety analysis after obtaining data on primary outcome in first 7 patients.

Secondary Outcome Measures

Efficacy of the treatment
Reduction of VT burden, ICD shocks and improvement in life quality as described by SF-36 (The Short Form Health Survey) v2 questionnaire. f eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability.
Biochemical markers of cardiac injury
Intensity and dynamics of changes in cardiac-related biochemical indices after treatment, like troponin, cardiac creatine kinase (MB-CK) concentration and N-terminal prohormone of brain natriuretic peptide (NT-proBNP) to assess the early cardiac muscle damage and changes in severity of congestive heart failure.
Late toxicity and mortality
Assessment of late toxicity including occurrence of cardiac-related hospitalizations and death.
Anti-arrhythmic drugs uptake
Changes in the anti-arrhythmic medications over time after treatment.
Cardiac injury
Assessment of the post-treatment cardiac injury including left ventricular ejection fraction, echocardiography and morphological changes in imaging studies.
Target volume delineation
Correlation of electrophysiological mapping with the results of additional cardiac imaging methods (MR, PET) - only in applicable patients (optional diagnostic methods)

Full Information

First Posted
November 19, 2020
Last Updated
March 14, 2023
Sponsor
Maria Sklodowska-Curie National Research Institute of Oncology
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1. Study Identification

Unique Protocol Identification Number
NCT04642963
Brief Title
Stereotactic Management of Arrhythmia - Radiosurgery in Treatment of Ventricular Tachycardia
Acronym
SMART-VT
Official Title
Stereotactic Management of Arrhythmia - Radiosurgery in Treatment of Ventricular Tachycardia
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
September 11, 2020 (Actual)
Primary Completion Date
January 10, 2023 (Actual)
Study Completion Date
January 10, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Maria Sklodowska-Curie National Research Institute of Oncology

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
Prospective single-arm study investigating the safety of non-invasive cardiac radiosurgery for the treatment of ventricular tachycardia (VT).
Detailed Description
The standard of care for the treatment of Ventricular Tachycardia (VT) comprises of pharmacotherapy, ICD implantation and electrophysiology-guided catheter ablation. The treatment, however, is associated with a relatively high risk of VT recurrence. Given the limited therapeutic options and significant impact on patients quality of life, non-invasive cardiac radiosurgery has been recently gaining popularity in scientific literature as a viable alternative to salvage catheter ablations. Considering the scarcity of data from prospective trials and concern about the safety of the treatment method, this trial seeks to determine whether Stereotactic Management of Arrhythmia - Radiosurgery in Treatment of Ventricular Tachycardia (SMART-VT) meets the expected safety requirements for clinical use.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ventricular Tachycardia
Keywords
Ventricular Tachycardia, Ablation, Noninvasive, Stereotactic Body Radiation Therapy, Radiosurgery, Substrate Ablation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
11 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cardiac Radiosurgery
Arm Type
Experimental
Arm Description
Patients with ventricular tachycardia will undergo a non-invasive cardiac radiosurgery using one fraction of 25 Gy to the arrhythmia substrate, as determined by the electrophysiological cardiac mapping.
Intervention Type
Radiation
Intervention Name(s)
Cardiac Radiosurgery
Other Intervention Name(s)
Stereotactic Arrhythmia Radioablation (STAR)
Intervention Description
Non-invasive delivery of ablative radiotherapy dose to the arrhythmia substrate.
Primary Outcome Measure Information:
Title
Acute toxicity evaluated using CTCAE v5.0 scale
Description
The study aims to demonstrate the safety of the treatment method defined as 3-month observation without Grade III or higher adverse events in at least 6 out of 7 patients (1st stage), and in total in at least 9 out of 11 patients (2nd stage) with an interim safety analysis after obtaining data on primary outcome in first 7 patients.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Efficacy of the treatment
Description
Reduction of VT burden, ICD shocks and improvement in life quality as described by SF-36 (The Short Form Health Survey) v2 questionnaire. f eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability.
Time Frame
24 months
Title
Biochemical markers of cardiac injury
Description
Intensity and dynamics of changes in cardiac-related biochemical indices after treatment, like troponin, cardiac creatine kinase (MB-CK) concentration and N-terminal prohormone of brain natriuretic peptide (NT-proBNP) to assess the early cardiac muscle damage and changes in severity of congestive heart failure.
Time Frame
24 months
Title
Late toxicity and mortality
Description
Assessment of late toxicity including occurrence of cardiac-related hospitalizations and death.
Time Frame
24 months
Title
Anti-arrhythmic drugs uptake
Description
Changes in the anti-arrhythmic medications over time after treatment.
Time Frame
24 months
Title
Cardiac injury
Description
Assessment of the post-treatment cardiac injury including left ventricular ejection fraction, echocardiography and morphological changes in imaging studies.
Time Frame
24 months
Title
Target volume delineation
Description
Correlation of electrophysiological mapping with the results of additional cardiac imaging methods (MR, PET) - only in applicable patients (optional diagnostic methods)
Time Frame
24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients with structural heart disease and implantable cardioverter defibrillator (ICD) Clinically significant arrhythmia with at least 3 VT episodes per month despite adequate pharmacological treatment. At least one episode of monomorphic VT registered in electrophysiological examination. Recurrent VT despite at least one prior catheter ablation and adequate pharmacotherapy OR contraindications to catheter ablation and/or pharmacotherapy (i.e., patient with medically contraindicated catheter ablation is obliged to undergo only pharmacotherapy prior to study enrollment). Patient must be able to understand and be willing to sign a written informed consent document. Exclusion Criteria: Heart failure requiring inotropic treatment or mechanical assistance Arrhythmia due to cardiac channelopathy Reversible source of arrhythmia NYHA (New York Heart Association) stage IV hearth failure Hearth infarction or cardiac surgery in last 3 months Life expectancy <6 months Polymorphic VT Pregnancy Prior radiotherapy to the thoracic region (relative contraindication) Failure to induce VT during electrophysiological examination
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sławomir Blamek, dr hab. n. med.
Organizational Affiliation
Maria Sklodowska-Curie National Research Institute of Oncology (MSCNRIO)
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Wojciech Wojakowski, prof. dr hab. n. med.
Organizational Affiliation
Upper Silesian Medical Center Professor Leszek Giec of the Medical University of Silesia in Katowice
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Marcin Miszczyk, dr n. med.
Organizational Affiliation
Maria Sklodowska-Curie National Research Institute of Oncology (MSCNRIO)
Official's Role
Study Chair
Facility Information:
Facility Name
Upper Silesian Medical Center Professor Leszek Giec of the Medical University of Silesia in Katowice
City
Katowice
Country
Poland
Facility Name
Maria Sklodowska-Curie National Research Institute of Oncology (MSCNRIO), Gliwice branch
City
Gliwice
State/Province
Śląskie
ZIP/Postal Code
44-102
Country
Poland

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Time Frame
The data will be shared within the European STOPSTORM consortium, which is dedicated to the development of cardiac radiosurgery for the treatment of ventricular tachycardia. The intention to share anonymized data with the consortium will be clearly explained, and a written consent will be obtained from each participant.

Learn more about this trial

Stereotactic Management of Arrhythmia - Radiosurgery in Treatment of Ventricular Tachycardia

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