Stereotactic Management of Arrhythmia - Radiosurgery in Treatment of Ventricular Tachycardia

Ventricular Tachycardia Clinical Trial

— SMART-VT  

Official title:

Stereotactic Management of Arrhythmia - Radiosurgery in Treatment of Ventricular Tachycardia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04642963
• Other study ID #: SMART-VT
• Status: Completed
• Phase: N/A
• Start date: September 11, 2020
• Est. completion date: January 10, 2023

Study information

• Verified date: March 2023
• Source: Maria Sklodowska-Curie National Research Institute of Oncology
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Prospective single-arm study investigating the safety of non-invasive cardiac radiosurgery for the treatment of ventricular tachycardia (VT).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11
• Est. completion date: January 10, 2023
• Est. primary completion date: January 10, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Tachycardia
• Tachycardia, Ventricular
• Ventricular Tachycardia

Intervention

Radiation:
• Cardiac Radiosurgery
Non-invasive delivery of ablative radiotherapy dose to the arrhythmia substrate.

Locations

Country	Name	City	State
Poland	Maria Sklodowska-Curie National Research Institute of Oncology (MSCNRIO), Gliwice branch	Gliwice	Slaskie
Poland	Upper Silesian Medical Center Professor Leszek Giec of the Medical University of Silesia in Katowice	Katowice

Sponsors (1)

Lead Sponsor	Collaborator
Maria Sklodowska-Curie National Research Institute of Oncology

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	3 months
Secondary	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.	24 months
Secondary	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.	24 months
Secondary	Late toxicity and mortality	Assessment of late toxicity including occurrence of cardiac-related hospitalizations and death.	24 months
Secondary	Anti-arrhythmic drugs uptake	Changes in the anti-arrhythmic medications over time after treatment.	24 months
Secondary	Cardiac injury	Assessment of the post-treatment cardiac injury including left ventricular ejection fraction, echocardiography and morphological changes in imaging studies.	24 months
Secondary	Target volume delineation	Correlation of electrophysiological mapping with the results of additional cardiac imaging methods (MR, PET) - only in applicable patients (optional diagnostic methods)	24 months