Stereotactic Management of Arrhythmia - Radiosurgery Treatment and Evaluation of Response in Ventricular Tachycardia (SMARTER-VT)

October 18, 2023 updated by: Maria Sklodowska-Curie National Research Institute of Oncology
Prospective single-arm study investigating the efficacy and safety of non-invasive cardiac radiosurgery for the treatment of ventricular tachycardia (VT) with reduced dose of radiation (20 Gy). The efficacy and safety outcome measures will be compared with historical control - patients treated within the SMART-VT study (NCT04642963) with a single dose of 25 Gy to test the hypothesis that reduced dose of radiation is similarly effective in terms of reduction of VT burden.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
20

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Poland
      • Gliwice, Poland, 44-102
      • Katowice, Poland, 40-635
        • Recruiting
        • Professor Leszek Giec Upper Silesian Medical Center of the Medical University of Silesia
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age ≥ 18 years
  • Patients with structural heart disease
  • Patients with implantable cardioverter defibrillator (ICD) or cardiac resynchronization therapy with defibrillation (CRT-D)
  • Clinically symptomatic ventricular arrhythmia despite adequate treatment, with episodes of ventricular tachycardia occurring at least 3 times per month
  • At least one episode of monomorphic ventricular tachycardia recorded during an electrophysiological examination
  • Recurrent VT despite at least one previous failed attempt at percutaneous ablation or disqualification from this treatment method (eg, patients after percutaneous closure of patent foramen ovale, ventricular septal defect).
  • Persistent recurrence of VT despite adequate pharmacotherapy.
  • Informed consent of the patient to participate in the study.

Exclusion Criteria:

  • Premature ventricular contractions
  • Cardiac damage requiring inotropic treatment
  • Implantation of left ventricular assist device (LVAD)
  • Ventricular arrhythmia in the course of channelopathy
  • Reversible cause of VT
  • New York Heart Association (NYHA) stage IV heart failure
  • Myocardial infarction or cardiac surgery in the last 3 months.
  • Life expectancy less than 6 months
  • Polymorphic ventricular tachycardia
  • Pregnancy or breastfeeding
  • Substrate location that prevents safe radiotherapy (eg due to location relative to critical organs, or dose given during previous radiotherapy treatments).
  • Evidence of an active systemic, pulmonary or pericardial inflammatory process that has required systemic treatment in the past 6 months (eg disease-modifying drugs, steroids, immunosuppressants). Patients treated for sarcoidosis who are currently in remission on chronic immunosuppressive drugs, without current signs of an acute inflammatory process, may be included in the study.
  • Active, uncontrolled malignancy and/or chemo/immunotherapy in the past month or planned within the month following radioablation.
  • Lack of the informed consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Cardiac radioablation
Patients with ventricular tachycardia will undergo cardiac radiosurgery with one fraction of 20 Gy to the arrhythmia substrate, as determined by the electrophysiological cardiac mapping.
Radiation: Stereotactic Body Radiotherapy
Non-invasive delivery of ablative radiotherapy dose to the arrhythmia substrate defined with electroanatomical mapping (EAM)
Other Names:
  • Stereotactic Arrhythmia Radioablation, Cardiac Radiosurgery

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Efficacy of the treatment
Time Frame: 6 months

Number of patients with a reduction of the number of ventricular tachycardia (VT) episodes by at least 50% within 6 months after the irradiation compared to the number of VT episodes within 6 months before the intervention (based on registration from ICD/CRT-D), including:

  • the number of high-energy discharges
  • number of low-energy discharges for VT that was treated with stereotactic radiotherapy (STAR)
6 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Six-month survival without VT episodes
Time Frame: 6 months
6 months
Number of patients with complete elimination of ICD discharges
Time Frame: 12 months
12 months
Number of patients with a 90% reduction in the number of ICD discharges
Time Frame: 12 months
12 months
Number of hospitalizations due to VT episodes
Time Frame: 12 months
12 months
Recurrences outside the irradiated area
Time Frame: 12 months
Number of patients who developed VT with a different morphology than specified during qualification for the procedure
12 months
Early treatment safety
Time Frame: 3 months
Number of serious adverse events (SAE) in the first 3 months after the intervention
3 months
Long term treatment safety
Time Frame: 12 months
Number of SAE episodes within 12 months after the intervention
12 months
Assessment of the intensity and dynamics of changes in biochemical parameters of myocardial damage.
Time Frame: 12 months
Intensity and dynamics of changes in cardiac-related biochemical indices after treatment, like troponin, cardiac creatine kinase (MB-CK) concentration and
12 months
Evaluation of complications and mortality, including cardiac mortality and emergency hospitalizations during post-treatment follow-up
Time Frame: 12 months
12 months
Change in the need for antiarrhythmic drugs
Time Frame: 12 months
12 months
Evaluation of changes in the left ventricular ejection fraction
Time Frame: 12 months
12 months
Evaluation of changes in the morphology of the heart in the ultrasound examination
Time Frame: 12 months
12 months
Assessment of compliance of the results of additional imaging with the results of EAM
Time Frame: 3 months
Correlation of data from electroanatomical mapping with the results of additional imaging studies (CT, echocardiogram, MRI if applicable)
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Maria Sklodowska-Curie National Research Institute of Oncology

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Leszek Giec Upper Silesian Medical Center of the Medical University of Silesia in Katowice, Poland

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Sławomir Blamek, MD, PhD, MBA, Maria Skłodowska-Curie National Research Institute of Oncology, Gliwice Branch
  • Principal Investigator: Wojciech Wojakwoski, MD, PhD, Professor Leszek Giec Upper Silesian Medical Center of the Medical University of Silesia in Katowice
  • Study Chair: Marcin Miszczyk, MD, PhD, Maria Skłodowska-Curie National Research Institute of Oncology, Gliwice Branch

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 24, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 13, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 13, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 22, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 19, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 18, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • KB/430-77/23

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The data will be shared within the European Standardized Treatment and Outcome Platform for Stereotactic Therapy Of Re-entrant tachycardia by a Multidisciplinary consortium (STOPSTORM). The intention to share the anonymized data with the consortium will be clearly explained, and a written consent will be obtained from each participant.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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