Phase I/II Randomized Study of Stereotactic Ablative Radiotherapy (SABR) Versus Standard of Care for Refractory Structural Cardiac Arrhythmias (SABR-HEART)

NCT05084391 | Withdrawn Phase 1 DMC FDA Device

• 2 other identifiers: 2019-0538NCI-2021-10672
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

Phase I: For the Phase I portion, there will be up to 15 patients treated with SABR and followed for 6 months post-treatment to ensure no significant acute grade 3 or 4 toxicity from SABR treatment. Efficacy as defined below will also be assessed. Following this Phase I lead-in, results will be presented to the FDA for review. Only upon favorable analysis by the FDA committee, and with written explicit permission, will the Phase II randomized portion ensue. This is to act as a safety and efficacy safeguard and has is addressed more thoroughly in the Statistical Analysis Plan of this protocol. Phase II: A 1:1 randomized Phase II portion with 25 patients in each arm assigned to SABR or current practice (standard of care; Figure 3). Standard of care is defined as nationally recognized appropriate next treatment strategies for medical and catheter-ablation refractory structural cardiac VT that is assessed and judged appropriate for the patient by his/her treating cardiologist. This includes repeat catheter ablation (intravascular and/or epicardial catheter ablation), placement of left-ventricular assist device (LVAD), heart transplant, or further medical management (e.g. antiarrhythmic drug modulation/continuation). Randomization will be performed through the Clinical Trial Conduct (CTC) website.

Conditions

Cardiac Arrhythmia; Cardiac; Ventricular Tachyarrhythmias

Outcome Measures

Primary Outcomes (1)

• The overall toxicity as assessed using CTCAE v4.0 will be used with SABR compared to next best management practices (standard of care) in treating refractory structural cardiac ventricular tachyarrhythmias (VT).

  through study completion, an average of 1 year

Study Arms (2)

Phase I:

EXPERIMENTAL

Phase I there will be up to 15 patients treated with SABR and followed for 6 months post-treatment to ensure no significant acute grade 3 or 4 toxicity from SABR treatment.

Device: stereotactic ablative radiotherapy (SABR); Other: Standard of Treatment

Phase II

EXPERIMENTAL

Phase II portion with 25 patients in each arm assigned to SABR or current practice (standard of care)

Device: stereotactic ablative radiotherapy (SABR); Other: Standard of Treatment

Interventions

stereotactic ablative radiotherapy (SABR) DEVICE

is safe for treating heart arrhythmias (irregular heartbeat

Phase I:; Phase II

Standard of Treatment OTHER

Standard of care

Phase I:; Phase II

Eligibility Criteria

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

You may qualify if:

• 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 recurrencerecurrent 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 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).

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• Patient-Centered Outcomes Research Institute: collaborator

Related Links

• M D Anderson Cancer Center

MeSH Terms

Conditions

Arrhythmias, Cardiac; Tachycardia, Ventricular

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Tachycardia; Cardiac Conduction System Disease

Study Officials

• Joe Chang, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 3, 2021
• First Posted: October 19, 2021
• Study Start: September 12, 2019
• Primary Completion: February 8, 2024
• Study Completion: February 8, 2024
• Last Updated: February 13, 2024

Record last verified: 2024-02