Noninvasive Cardiac Radioablation for Ventricular Tachycardia Refractory to Medication and Catheter Ablation

NCT04757688 | Withdrawn DMC FDA Device

• 1 other identifier: IRB-300006881
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the safety and efficacy of cardiac radioablation (CRA) as a means of noninvasive treatment of ventricular tachycardia (VT) refractory to both medication and catheter ablation.

Conditions

Ventricular Tachycardia

Keywords

Cardiac radioablation; Cardiac SBRT

Outcome Measures

Primary Outcomes (1)

• Reduction in ICD treatments for VT (≥ 50 percent)

  Number of subjects with ≥ 50 percent reduction in number of ICD treatments for VT (shocks or anti-tachycardia pacing, ATP) comparing 5 month period before CRA to 6 months after CRA (excluding 1 month blanking period post CRA).

  6 months

Secondary Outcomes (3)

• Severe adverse event rate ≤ 20 percent

  3 months

• Reduction in ICD treatments for VT (≥ 95 percent)

  6 months

• Elimination of ICD shocks

  5 years

Study Arms (1)

Cardiac radioablation (CRA)

EXPERIMENTAL

CRA delivered via linear accelerator (stereotactic body radiotherapy) to the suspected arrhythmogenic substrate to a dose of 25 Gy in 1 fraction.

Radiation: Cardiac radioablation (CRA)

Interventions

Cardiac radioablation (CRA) RADIATION

CRA to 25 Gy in 1 fraction

Cardiac radioablation (CRA)

Eligibility Criteria

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

You may qualify if:

• Patients must be ≥ 18 years old.
• Patients must have documented sustained monomorphic VT by 12-lead ECG or intracardiac ICD interrogation.
• Minimum VT burden: 4 or more documented VT episodes (including sustained VT, ICD anti-tachycardia pacing \[ATP\], or ICD shock) in the 5 months preceding enrollment on this trial. Patients must have at least two episodes of electrocardiographically documented symptomatic, recurrent, sustained monomorphic VT in the 3 months prior to enrollment
• \*ATP and appropriate ICD shock are acceptable surrogates for VT-associated symptoms
• Patients must have an ICD.
• Patients must have ischemic or non-ischemic cardiomyopathy previously diagnosed with LVEF ≤ 35%.
• Patients must have received at least one antiarrhythmic medication (i.e. amiodarone, sotalol, mexiletine) without control of symptoms or with poor toleration. AND Patients must have undergone at least one catheter-ablation procedure (or have a contraindication to catheter-ablation) or have VT arising from an inaccessible location.
• Contra-indications to endocardial catheter ablation procedure include dual aortic and mitral mechanical valves, active left ventricular thrombus, and anesthesia intolerance.
• Contra-indications to epicardial catheter ablation include prior cardiac surgery or anesthesia intolerance.
• Patients with ischemic cardiomyopathy should have failed at least one endocardial ablation performed at an academic center.
• Patients with non-ischemic cardiomyopathy should have failed both epicardial and endocardial ablations, unless epicardial mapping/ablation is not feasible.
• Ability to understand and willingness to sign an IRB approved informed consent document (legally authorized representatives are not permissible).
• An independent EP cardiologist must confirm that each study participant has met the study entrance criteria, has failed conventional therapies, and has frequent recurrent VT episodes that warrant further rhythm management.

You may not qualify if:

• Patients who have received any prior radiotherapy to the internal organs of the thorax or upper abdomen (with treatment field extending superior to L1 vertebral body) at any time in the past are excluded.
• Patients found to have multiple scars on electrocardiographic imaging where the source of reentrant focus is unclear despite positron emission tomography (PET)/magnetic resonance imaging (MRI) are excluded.
• Patients who have congestive heart failure on inotropes (NYHA class 4B) or left-ventricular assist device are excluded.
• Patients felt to be unlikely to live 12 months in the absence of VT are excluded.
• Patients with polymorphic VT or ventricular fibrillation, \>3 distinct clinical VT morphologies on ICD interrogation, or \>5 induced VT morphologies during noninvasive testing are excluded.
• Patients with incessant VT that is hemodynamically unstable are excluded.
• Patients in VT storm are excluded.
• Patients must not be pregnant and must have a negative pregnancy test within 14 days of study entry if they are females of childbearing age.

Sponsors & Collaborators

• John Stahl: lead
• Washington University School of Medicine: collaborator

Study Sites (1)

University of Alabama at Birmingham (UAB) Department of Radiation Oncology

Birmingham, Alabama, 35249, United States

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

• John Stahl, MD

  University of Alabama at Birmingham (UAB)

  PRINCIPAL INVESTIGATOR

• Cliff Robinson, MD

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

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: Principal Investigator

Study Record Dates

• First Submitted: February 12, 2021
• First Posted: February 17, 2021
• Study Start: November 1, 2022
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2028
• Last Updated: November 9, 2022

Record last verified: 2022-11

Locations

US (1)