Stereotactic Ablative Radiotherapy for Treatment of Recurrent Heart Arrhythmias in Patients with Heart Disease

Status: withdrawn

This phase I/II trial tests the safety, side effects, whether stereotactic ablative radiotherapy (SABR) works in treating heart arrhythmias (irregular heartbeat) that do not response to treatment (refractory) in patients with heart disease. Stereotactic body radiation therapy uses special equipment to position a patient and deliver radiation to tumors with high precision. This method may kill tumor cells with fewer doses over a shorter period and cause less damage to normal tissue.

Inclusion Criteria

Eastern Cooperative Oncology Group (ECOG) 0-2
Age 18 years or older
Diagnosis of recurrent sustained monomorphic VT (MMVT) in the setting of structural heart disease
ICD placement and at least two (2) episodes of recurrence recurrent sustained MMVT that are terminated by anti-tachycardia pacing (ATP) or ICD shocks confirmed by device interrogation in the preceding 3 months, since the last VT ablation procedure in subjected who have failed catheter ablation
Failed at least 1 anti-arrhythmic medication (not including beta-blockers) as evidenced by persistent VT (including amiodarone and/or sotalol)
At least 1 attempted catheter ablation procedure with voltage and/or activation 3 dimensional (3D) mapping. For patients with ischemic cardiomyopathy this would include failure of at least one endocardial ablation performed at an experienced center. For patients with non-ischemic cardiomyopathy, both endocardial and epicardial ablation should have been attempted unless epicardial ablation/mapping is not feasible (e.g. patient tolerance, deemed futile by EP, prior cardiac surgery)
Patients are eligible regardless of past or present oncologic history

Exclusion Criteria

Unlikely to live at least 12 months in the absence of VT, as assessed by physicians
Heart failure dependent on ionotropes
Left ventricular assist device
Polymorphic VT
Ventricular fibrillation
5 or more VT morphologies during stimulation testing suggestive of more than one arrhythmogenic substrate
Prior radiation treatment to the chest for any reason
Last invasive catheter ablation attempt <2 weeks
Lack of ICD data in preceding 3 months
Unable/unwilling to provide informed consent
Idiopathic VT
Women who are pregnant
Heart transplant
Active ischemia or other reversible causes of VT
Active non-cardiovascular illness or systemic infection
Cardiogenic shock
Presence of incessant VT that is hemodynamically unstable
Acute heart failure exacerbation
Revascularization in the past 30 days
Left ventricular ejection fraction <15%
Scar tissue exceeding 80cc in volume planning treatment volume (PTV) >= 300cc

PRIMARY OBJECTIVES:

I. Assess acute toxicity and efficacy with SABR in treating refractory structural cardiac ventricular tachyarrhythmias (VT). (Phase I)

II. Investigate overall toxicity with SABR compared to next best management practices (standard

of care) in treating refractory structural cardiac ventricular tachyarrhythmias (VT). (Phase II)

III. Investigate VT episode reduction with SABR compared to standard of care to evaluate effectiveness and potential superiority of SABR to current day options. (Phase II)

SECONDARY OBJECTIVES:

I. 6-month and 1-year overall survival (OS) of SABR compared to standard of care.

II. Quality of life (QOL) with SABR compared to standard of care (baseline and at 6 months after randomization).

III. Hospitalization-free survival with SABR compared to standard of care (evaluated at 1-year).

IV. Cost-effectiveness analysis with SABR compared to standard of care (evaluated at 1-year).

V. Freedom-from Antiarrhythmic medications with SABR compared to standard of care (evaluated at 1-year).

VI. Freedom-from electrical storm with SABR compared to standard of care (evaluated at 1-year).

VII. Treatment-free Survival with SABR compared to standard of care (evaluated at 1–year).

VIII. Event-free survival with SABR compared to standard of care (evaluated at 1-year).

IX. Long term (> 1 year) toxicity with SABR compared to standard of care (evaluated at 1-year).

X. Ejection fraction improvement with SABR compared to standard of care (evaluated at 1-year).

XI. Transplant/left ventricular assist device (LVAD)-free survival with SABR compared to standard of care (evaluated at 1-year).

XII. Number, type, and treatment success and cycle length of implantable cardioverter defibrillator (ICD)-treated VTs with SABR compared to standard of care (evaluated at 1-year).

XIII. Parameters obtained from cardiac imaging, and/or serum markers will be associated with frequency of survival, response to treatment, and toxicity at regular time intervals using cardiac echocardiography (ECHO), magnetic resonance imaging (MRI), computed tomography (CT) imaging, ICD interrogation, and/or serum/blood work studies for prognostic/predictive biomarker and radiomic identification.

OUTLINE: This is a phase I, safety study of SABR followed by a phase II randomized study. Patients are randomized to 1 of 2 arms.

PHASE I: Patients undergo SABR over 30-45 minutes. Patients are then followed for 6 months.

PHASE II: Patients are randomized in 1 of 2 arms.

ARM I: Patients undergo SABR for 30-45 minutes.

ARM II: patients receive standard of care.

After completion of the study treatment, patients are followed up every 3 months for 1 year and every 6 months for 4 years, and then annually thereafter.

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Stereotactic Ablative Radiotherapy for Treatment of Recurrent Heart Arrhythmias in Patients with Heart Disease

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