Stereotactic Management of Arrhythmia - Radiosurgery in Treatment of Ventricular Tachycardia

NCT04642963 | Completed

• 1 other identifier: SMART-VT
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Ventricular Tachycardia

Keywords

Ventricular Tachycardia; Ablation; Noninvasive; Stereotactic Body Radiation Therapy; Radiosurgery; Substrate Ablation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Efficacy of the treatment

  24 months

• Biochemical markers of cardiac injury

  24 months

• Late toxicity and mortality

  24 months

• Anti-arrhythmic drugs uptake

  24 months

• Cardiac injury

  24 months

Study Arms (1)

Cardiac Radiosurgery

EXPERIMENTAL

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.

Radiation: Cardiac Radiosurgery

Interventions

Cardiac Radiosurgery RADIATION

Non-invasive delivery of ablative radiotherapy dose to the arrhythmia substrate.

Also known as: Stereotactic Arrhythmia Radioablation (STAR)

Cardiac Radiosurgery

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Maria Sklodowska-Curie National Research Institute of Oncology: lead

Study Sites (2)

Maria Sklodowska-Curie National Research Institute of Oncology (MSCNRIO), Gliwice branch

Gliwice, Silesian Voivodeship, 44-102, Poland

Location

Upper Silesian Medical Center Professor Leszek Giec of the Medical University of Silesia in Katowice

Katowice, Poland

Location

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

• Sławomir Blamek, dr hab. n. med.

  Maria Sklodowska-Curie National Research Institute of Oncology (MSCNRIO)

  PRINCIPAL INVESTIGATOR

• Wojciech Wojakowski, prof. dr hab. n. med.

  Upper Silesian Medical Center Professor Leszek Giec of the Medical University of Silesia in Katowice

  PRINCIPAL INVESTIGATOR

• Marcin Miszczyk, dr n. med.

  Maria Sklodowska-Curie National Research Institute of Oncology (MSCNRIO)

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: dr hab. n. med.

Study Record Dates

• First Submitted: November 19, 2020
• First Posted: November 24, 2020
• Study Start: September 11, 2020
• Primary Completion: January 10, 2023
• Study Completion: January 10, 2023
• Last Updated: March 15, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR, ANALYTIC CODE
• 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.

Locations

PL (2)