Phase I/II Study of EP-guided Noninvasive Cardiac Radioablation for Treatment of Ventricular Tachycardia

NCT ID: NCT02919618

Last Updated: 2024-08-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 19 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-07-31
• Study Completion Date: 2024-01-01

Brief Summary

Phase I/II Study of EP-guided Noninvasive Cardiac Radioablation (ENCORE) for Treatment of Ventricular Tachycardia

Detailed Description

Patients with Ventricular Tachycardia (VT) who have failed standard therapy (medicines, invasive catheter ablation) have limited options, with one-year survival below 20%. Preclinical data demonstrate that single fraction stereotactic body radiotherapy (SBRT) to discrete portions of the heart is feasible and may result in a reduction or elimination of VT. The efficacy may be further improved when guided by cardiac electrophysiologic (EP) testing. In total, the mapping and ablation proposed for this EP-guided Noninvasive Cardiac Radioablation (ENCORE) is a rapid and totally non-invasive method. Overall safety and early efficacy of ENCORE have not been rigorously studied in a prospective trial to-date. The purpose of this phase I/II study is to demonstrate the short-term safety and preliminary efficacy of ENCORE for patients with life-threatening, treatment-refractory VT.

Conditions

Ventricular Tachycardia; Cardiomyopathy; Premature Ventricular Contractions

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

stereotactic body radiotherapy (SBRT)

Noninvasive SBRT will be delivered in a single fraction to a region of the heart determined by EP-guidance, using noninvasive electrical mapping combined with anatomic imaging.

Group Type: EXPERIMENTAL

stereotactic body radiotherapy (SBRT)

Intervention Type: RADIATION

(Cardiac ablative radiotherapy)

Interventions

stereotactic body radiotherapy (SBRT)

(Cardiac ablative radiotherapy)

Intervention Type: RADIATION

Eligibility Criteria

Inclusion Criteria

1. DOCUMENTED VT:

1. Patient must have documented sustained monomorphic ventricular tachycardia as documented on either a 12-lead ECG or intracardiac ICD interrogation

• OR-

2. Monomorphic PVCs documented on a 12-lead ECG.

2. ANTIARRHYTHMIC MEDICATION: Patient must have failed or become intolerant to at least one antiarrhythmic medication (amiodarone, sotalol, or mexiletine).

-AND-

3. CATHETER ABLATION: Patient must have failed at least one invasive catheter ablation procedure, or have a contraindication to a catheter ablation procedure (e.g., LV thrombus, severe pulmonary disease), or have VT thought to arise from a protected location (e.g., epicardial VT with history of previous cardiac surgery).

4. MINIMUM VT BURDEN: Patient must have either:

1. At least 3 VT episodes (sustained VT, ICD ATP or ICD shock) over previous 6 months prior to enrollment -OR-

2. >20% PVC burden with a cardiomyopathy (LVEF<50%)

5. Patient must be deemed medically fit for stereotactic body radiation therapy by the treating physician.

6. Patient must be > 18 years old.

7. Patient must be able to understand and be willing to sign an IRB approved written informed consent document.

-

Exclusion Criteria

1. Patient must not have past history of radiotherapy within the projected treatment field.

2. Advanced symptomatic heart failure as defined as NYHA Class IV heart failure (inotrope dependent and/or current left-ventricular assist device (LVAD))

3. Polymorphic VT or ventricular fibrillation (VF) as a clinical heart rhythm (as determined by 12-lead ECG and/or ICD interrogation).

4. More than 3 distinct clinical VT morphologies observed (ECG or ICD interrogation or invasive EP study) OR more than 5 distinct induced VT morphologies during ECGI testing.

5. Advanced myocardial scar substrate that would require stereotactic delivery to a target volume deemed unsafe by the treating physician.

6. Unlikely to live 12 months, in the absence of VT, as best based on clinical judgment by the treating and enrolling physicians.

7. Patient must not be pregnant and/or breastfeeding and must have a negative pregnancy test within 14 days of study entry.

-

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Washington University School of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Phillip Cuculich

M.D.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Phillip Cuculich, MD

Role: PRINCIPAL_INVESTIGATOR

Washington University School of Medicine

Locations

Washington University School of Medicine

St Louis, Missouri, United States

Countries

United States

References

Robinson CG, Samson PP, Moore KMS, Hugo GD, Knutson N, Mutic S, Goddu SM, Lang A, Cooper DH, Faddis M, Noheria A, Smith TW, Woodard PK, Gropler RJ, Hallahan DE, Rudy Y, Cuculich PS. Phase I/II Trial of Electrophysiology-Guided Noninvasive Cardiac Radioablation for Ventricular Tachycardia. Circulation. 2019 Jan 15;139(3):313-321. doi: 10.1161/CIRCULATIONAHA.118.038261.

Reference Type: DERIVED

PMID: 30586734 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

201606081

Identifier Type: -

Identifier Source: org_study_id