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

NCT02919618 | Completed Phase 1 Results DMC

• 1 other identifier: 201606081
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Ventricular Tachycardia; Cardiomyopathy; Premature Ventricular Contractions

Keywords

Ventricular Tachycardia; Ablation; Noninvasive

Outcome Measures

Primary Outcomes (2)

• Number of Serious Adverse Events

  Demonstrate acute (≤ 90 days) safety of noninvasive stereotactic cardiac ablation radiotherapy (ENCORE). The primary safety endpoint is defined by a ≤ 20% rate of serious adverse events (SAEs) using CTCAE v4.0 criteria that are possibly/probably/definitely related to study treatment, based on previously published data for expected invasive catheter-based VT-ablation procedures.

  < or = 90 days

• Number of Participants With Reduction in Ventricular Tachycardia (VT) Burden

  Primary efficacy endpoint is defined by the number of subjects with a reduction in VT burden comparing the period six months before ENCORE treatment to the six months after ENCORE treatment as adjudicated by continuous ICD monitoring (number of ATP and ICD shocks and sustained (\>30 second) nontreated slow VT). There will be a six-week "blanking period" after therapy to allow for ablation effect. For patients with PVC-induced cardiomyopathy, the primary efficacy will be any reduction in PVC burden based on ambulatory heart monitors.

  12 months (6mo prior to and 6mo post SBRT)

Secondary Outcomes (7)

• Overall Survival

  12 months

• Number of Adverse Events That Are Possibly/Probably/Definitely Related to Study Treatment

  90 days to 12 months

• Health Related Quality of Life (HRQOL)

  6 week, 6 month, 12 month

• Number of Participants With a 50% Reduction in Ventricular Tachycardia (VT) Burden

  6 months

• Number of Participants With a 95% Reduction in Ventricular Tachycardia (VT) Burden

  6 months

Study Arms (1)

stereotactic body radiotherapy (SBRT)

EXPERIMENTAL

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.

Radiation: stereotactic body radiotherapy (SBRT)

Interventions

stereotactic body radiotherapy (SBRT) RADIATION

(Cardiac ablative radiotherapy)

stereotactic body radiotherapy (SBRT)

Eligibility Criteria

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

You may qualify if:

• DOCUMENTED VT:
• Patient must have documented sustained monomorphic ventricular tachycardia as documented on either a 12-lead ECG or intracardiac ICD interrogation
• \- OR-
• Monomorphic PVCs documented on a 12-lead ECG.
• ANTIARRHYTHMIC MEDICATION: Patient must have failed or become intolerant to at least one antiarrhythmic medication (amiodarone, sotalol, or mexiletine).
• AND-
• 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).
• MINIMUM VT BURDEN: Patient must have either:
• At least 3 VT episodes (sustained VT, ICD ATP or ICD shock) over previous 6 months prior to enrollment -OR-
• \>20% PVC burden with a cardiomyopathy (LVEF\<50%)
• Patient must be deemed medically fit for stereotactic body radiation therapy by the treating physician.
• Patient must be \> 18 years old.
• Patient must be able to understand and be willing to sign an IRB approved written informed consent document.

You may not qualify if:

• Patient must not have past history of radiotherapy within the projected treatment field.
• Advanced symptomatic heart failure as defined as NYHA Class IV heart failure (inotrope dependent and/or current left-ventricular assist device (LVAD))
• Polymorphic VT or ventricular fibrillation (VF) as a clinical heart rhythm (as determined by 12-lead ECG and/or ICD interrogation).
• 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.
• Advanced myocardial scar substrate that would require stereotactic delivery to a target volume deemed unsafe by the treating physician.
• Unlikely to live 12 months, in the absence of VT, as best based on clinical judgment by the treating and enrolling physicians.
• Patient must not be pregnant and/or breastfeeding and must have a negative pregnancy test within 14 days of study entry.

Sponsors & Collaborators

• Washington University School of Medicine: lead

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Related Publications (1)

• 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.

  PMID: 30586734 DERIVED

MeSH Terms

Conditions

Tachycardia, Ventricular; Cardiomyopathies; Ventricular Premature Complexes

Interventions

Radiosurgery

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Dr. Phillip Cuculich
• Organization: Washington University

pcuculic@wustl.edu

314-454-7698

Study Officials

• Phillip Cuculich, MD

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D.

Model Details: Noninvasive Cardiac Radioablation, all subjects

Study Record Dates

• First Submitted: September 28, 2016
• First Posted: September 29, 2016
• Study Start: July 1, 2016
• Primary Completion: July 23, 2018
• Study Completion: January 1, 2024
• Last Updated: August 21, 2024
• Results First Posted: September 10, 2019

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL

Locations

US (1)