Cohort Study - SBRT for VT Radioablation

NCT04162171 | Recruiting

• 1 other identifier: Sapp007
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

Ventricular tachycardia (VT) contributes to over 350,000 sudden deaths each year in the US. Malignant VTs involve an electrical "short circuit" in the heart, formed by narrow channels of surviving tissue inside myocardial scar. Current treatment for VT consists of either implantable defibrillators (ICDs), suppressive drug therapy, catheter ablation or a combination of all 3. Implantable Defibrillators (ICDs) reduce sudden death and can terminate some ventricular tachycardia (VT) without shocks, but they don't prevent VT. The occurrence of ≥1 ICD shock is associated with reductions in mental well-being and physical functioning, and increases in anxiety and sometimes depression. Further, ICD shocks have been consistently associated with adverse outcomes, including heart failure and death. Furthermore, the most important predictor of ICD shocks is a history of prior ICD shocks. Therapies to suppress VT include antiarrhythmic drug therapy and catheter ablation, neither however is universally effective. When VT recurs despite antiarrhythmic drug therapy and catheter ablation, novel yet invasive, approaches may be required. Such invasive procedures carry consequent risks of cardiac and extra-cardiac injury. Stereotactic body radiotherapy (SBRT) is a non-invasive technique that delivers high doses of radiation precisely to specified regions in the body, while minimizing exposure to adjacent tissue. This technique is currently, and commonly used in the treatment of cancer. Conventional application of SBRT has made use of its ability to spare non-target tissue, including for treatment of tumors near the heart. More recently, clinicians have changed the paradigm, by focusing radioablative energy on ventricular scar responsible for ventricular tachycardia. Pre-clinical studies have supported the concept and were followed by first-in-human VT therapeutic experience in 2017. Subsequent studies have had encouraging results for patients who failed or were unable to tolerate conventional treatment.

Conditions

Ventricular Tachycardia; Myocardial Infarction; Heart Disease Structural Disorder

Outcome Measures

Primary Outcomes (2)

• Comparative analysis of ventricular arrhythmia events

  Number of patients with a reduction in the absolute number of ventricular arrhythmia events following ablation and blanking period, in comparison with those prior to treatment.

  During the first 6 months post blanking period vs. 6 months prior to treatment.

• Comparative analysis of targeting methods assessed by volume of sparred healthy tissue

  Effectiveness of different myocardial substrate targeting methods on sparing non-target tissue. Delivered treatment approach as compared to a proposed calculated treatment plan using a single phase of the 4DcCT. Measured differences between 2 target-method volumes will equate to the volume of sparred tissue.

  From time of enrollment to 7.5 ,months post treatment.

Secondary Outcomes (3)

• Number of patients with procedural complications, including: all cause mortality, pericarditis, pneumonitis, heart failure hospitalization and extra-cardiac injury

  Through study completion,min of 7.5 months to max of 2 years.

• Time to Recurrent Arrhythmia Outcomes

  Through study completion,min of 7.5 months to max of 2 years

• Ventricular arrhythmia Burden

  During 6 months prior vs. 6 months following treatment.

Study Arms (1)

Imaging & SBRT Treatment for Ventricular Tachycardia

EXPERIMENTAL

Radiation: Stereotactic Body Radiotherapy (SBRT) ablation of VT

Interventions

Stereotactic Body Radiotherapy (SBRT) ablation of VT RADIATION

Additional imaging for SBRT planning and implementation: * Planning CT (pCT) - CT simulator that utilizes a respiratory positioning monitoring (RPM) optical tracking system and SBRT immobilization setup to provide necessary data to allow for monitoring of the patient's deep inspiration breath-hold (DIGH) maneuver during treatment delivery. * SBRT treatment - 30 min procedure on a TrueBeam 1 linear accelerator using SBRT fixation. Patient alignment and DIBH maneuver from the pCT will be replicated using the on-board cone-beam CT (CBCT) guidance and RPM systems.

Also known as: VT Radioablation

Imaging & SBRT Treatment for Ventricular Tachycardia

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Structural heart disease: ischemic or non-ischemic cardiomyopathy diagnosed with cardiac imaging demonstrating either segmental myocardial dysfunction, or presence of scar, AND
• One of the following monomorphic VT events despite prior attempted catheter ablation (or contraindication for ablation), AND despite treatment with a class III antiarrhythmic drug (contraindicated, ineffective or not tolerated): A: Documented sustained monomorphic VT terminated by pharmacologic means, DC cardioversion or manual ICD Therapy. B: ≥3 episodes of monomorphic VT treated with antitachycardia pacing (ATP), at least one of which was symptomatic C: ≥ 5 episodes of monomorphic VT treated with antitachycardia pacing (ATP) regardless of symptoms D: ≥1 appropriate ICD shocks, E: ≥3 monomorphic VT episodes within 24 hours \*\* VT events must be confirmed by ECG/monitor or ICD download.

You may not qualify if:

• Unable or unwilling to provide informed consent
• Have received prior radiotherapy to the likely treatment field
• Inotrope-dependent heart failure or an anticipated life-expectancy of \< 1 year in the absence of VT
• Presenting arrhythmia: polymorphic VT or ventricular fibrillation (VF)
• Pregnancy
• Active ischemia (acute thrombus diagnosed by coronary angiography, or dynamic ST segment changes demonstrated on ECG) or another reversible cause of VT (e.g. drug-induced arrhythmia), had recent acute coronary syndrome within 30 days thought to be due to acute coronary arterial thrombosis, or have CCS functional class IV angina. Note that biomarker level elevation alone after ventricular arrhythmias does not denote acute coronary syndrome or active ischemia.

Sponsors & Collaborators

• John Sapp: lead

Study Sites (1)

Nova Scotia Health Authority

Halifax, Nova Scotia, B3H 3A7, Canada

RECRUITING

MeSH Terms

Conditions

Tachycardia, Ventricular; Myocardial Infarction

Interventions

Radiosurgery

Condition Hierarchy (Ancestors)

Tachycardia; Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Cardiac Conduction System Disease; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Myocardial Ischemia; Vascular Diseases; Infarction; Ischemia; Necrosis

Intervention Hierarchy (Ancestors)

Radiotherapy; Therapeutics; Stereotaxic Techniques; Neurosurgical Procedures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• John Sapp, MD FRCPC

  Nova Scotia Health Authority

  PRINCIPAL INVESTIGATOR

• James Clarke, MD FRCPC

  Nova Scotia Health Authority

  STUDY DIRECTOR

• James Robar, Phd FCCPM

  Nova Scotia Health Authority

  STUDY DIRECTOR

• Jean-Philippe Pignol, MD FRCPC

  Nova Scotia Health Authority

  STUDY DIRECTOR

Central Study Contacts

Karen Giddens

CONTACT

902 237-5551; karen.giddensl@nshealth.ca

John Sapp, MD FRCPC

CONTACT

902.473.4474; John.Sapp@nshealth.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Staff Physician, Division of Cardiology

Study Record Dates

• First Submitted: October 29, 2019
• First Posted: November 14, 2019
• Study Start: June 1, 2021
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: March 18, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)