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Cardiac RADIoablation Versus Repeat Catheter Ablation: a Pivotal Randomized Clinical Trial Evaluating Safety and Efficacy for Patients With High-risk Refractory Ventricular Tachycardia (RADIATE-VT) (RADIATE-VT)

Primary Purpose

Tachycardia, Ventricular

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Varian Cardiac Radioablation (CRA)
Catheter Ablation (CA)
Sponsored by
Varian, a Siemens Healthineers Company
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tachycardia, Ventricular focused on measuring Cardiac radioablation, Ventricular tachycardia, Catheter ablation, Refractory ventricular tachycardia, High risk, SBRT

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: High-risk refractory VT, defined as: Ischemic and/or nonischemic cardiomyopathy, and Recurrent sustained monomorphic VT, defined as at least one of the following below, documented by ICD interrogation or ECG in the prior 6 months, and having occurred after the last VT ablation: A: ≥3 episodes of monomorphic VT treated with anti-tachycardia pacing (ATP) at least one of which is symptomatic B: ≥1 appropriate ICD shock C: ≥3 episodes of sustained monomorphic VT within 24 hours treated with ICD shock or ATP D: sustained monomorphic VT below detection rate of ICD documented by ECG, and Left ventricular ejection fraction (LVEF) ≤35% and Previously underwent at least one standard of care CA for VT. Presence of a clinical indication for a repeat CA procedure for scar-mediated VT in the judgement of the treating investigator. Has failed amiodarone therapy or is intolerant to amiodarone: Failed amiodarone therapy is defined as: appropriate ICD therapy or sustained monomorphic VT having occurred while the patient was taking amiodarone (minimum cumulative dose of 10 g). Intolerant to amiodarone is defined as: previously tried or taken amiodarone but stopped due to medication related side effects or toxicities. Deemed to be medically and technically a candidate for further CA by the electrophysiologist investigator. Presence of an ICD. At least 18 years of age (or meets local age of majority). Ability to understand and willingness to sign an IRB approved written informed consent document. Exclusion Criteria: Contraindication to a CA procedure for VT (e.g., presence of mobile LV thrombus, active systemic infection, active ischemic or other reversible causes of VT). Any prior radiation to the thorax region of the body. Known medical conditions associated with higher risk of radiotherapy complications in the judgement of the radiation oncologist (i.e., active connective tissue disorders, interstitial lung disease, etc.) that would preclude safe delivery of CRA. Current use of inotropes. Presence of a left-ventricular assist device (LVAD). Scheduled for LVAD or heart transplant procedures. Presence of a systemic illness likely to limit survival to < 1 year. VT ablation procedure performed within the prior 4 weeks. Polymorphic VT or ventricular fibrillation (VF) as the primary clinical heart rhythm, as indicated by 12-lead ECG and/or ICD interrogation. >3 distinct clinical monomorphic VT morphologies on ICD interrogation since the prior CA, or >5 induced monomorphic VT morphologies during NIPS testing. Incessant VT that is hemodynamically unstable. Bundle branch reentry (BBR) VT. Pregnant and/or breastfeeding. (Patient denial is sufficient for enrollment). Patients of childbearing potential who: are not on a medically effective means of birth control at the time of screening or do not start a medically effective means of birth control prior to randomization; or do not agree to continue medically effective means of birth control until they have completed their assigned therapy; or do not agree to be on a medically effective means of birth control if they are treated with CRA after their index CA procedure. Patients enrolled in another clinical study the investigator believes to be in conflict with this clinical investigation. Patients enrolled or planned to be enrolled in another cardiac radioablation clinical study or registry. Patients with any other medical condition or laboratory value that would, at the discretion of the investigator, preclude the patient from participation in this clinical investigation.

Sites / Locations

  • Hartford HospitalRecruiting
  • Washington UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Repeat catheter ablation (CA)

Varian Cardiac Radioablation (CRA)

Arm Description

Outcomes

Primary Outcome Measures

Co-primary safety endpoint: freedom from treatment-attributed (i.e., probably or definitely related) serious adverse events (SAEs)
Freedom from treatment-attributed (i.e., probably or definitely related) serious adverse events (SAEs), evaluated from treatment through 12 months post-treatment.
Co-primary efficacy endpoint: Freedom from death, and appropriate ICD shock, and VT storm.
Freedom from death, and appropriate ICD shock, and VT storm, where death will be counted from randomization through 12 months, and shock and storm will be counted starting after a 30-day period immediately post-randomization and continuing through 12 months post randomization.

Secondary Outcome Measures

Change in quality of life at 6 weeks post treatment:
Change in quality of life at 6 weeks post treatment measured by the Short Form Health Survey 36 (SF-36) Health Change Question. This item asks the subject to rate their health in general compared to one year ago in a 5-point scale of 1 (much better), 2 (somewhat better), 3 (about the same), 4 (somewhat worse), 5 (much worse).
VT burden reduction
VT burden reduction measured as a ≥75% reduction in appropriate ICD therapies (ATP, shock), comparing a 6-month period before randomization and a 6-month period starting after a 30-day period immediately post-randomization.
Change in quality of life (Social Functioning) at 6 weeks post treatment
Change in quality of life (Social Functioning) measured by the Short Form Health Survey 36 (SF-36) Social Functioning item (social activities in past 4 weeks). This item asks the subject to rate how much of the time their physical health or emotional problems interfered with their social activities in the past 4 weeks in a 5-point scale of 1 (All of the time), 2 (Most of the time), 3 (Some of the time), 4 (A little bit of the time), 5 (None of the time).

Full Information

First Posted
February 15, 2023
Last Updated
May 31, 2023
Sponsor
Varian, a Siemens Healthineers Company
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1. Study Identification

Unique Protocol Identification Number
NCT05765175
Brief Title
Cardiac RADIoablation Versus Repeat Catheter Ablation: a Pivotal Randomized Clinical Trial Evaluating Safety and Efficacy for Patients With High-risk Refractory Ventricular Tachycardia (RADIATE-VT)
Acronym
RADIATE-VT
Official Title
Cardiac RADIoablation Versus Repeat Catheter Ablation: a Pivotal Randomized Clinical Trial Evaluating Safety and Efficacy for Patients With High-risk Refractory Ventricular Tachycardia
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 21, 2023 (Actual)
Primary Completion Date
May 2026 (Anticipated)
Study Completion Date
May 2030 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Varian, a Siemens Healthineers Company

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
RADIATE-VT is a pivotal, multicenter, randomized trial comparing safety and efficacy between cardiac radioablation (CRA) using the Varian CRA System and repeat catheter ablation (CA), for patients with high-risk refractory ventricular tachycardia (VT) who have experienced VT recurrence after CA and are candidates for additional CA.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tachycardia, Ventricular
Keywords
Cardiac radioablation, Ventricular tachycardia, Catheter ablation, Refractory ventricular tachycardia, High risk, SBRT

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
The Varian CRA trial is a multicenter, international, pivotal, 2-arm randomized controlled trial (RCT). Subjects will be randomized 1:1 to CRA or repeat CA. Randomization will be stratified by (1) enrolling institution and (2) NYHA class I/II vs. III/IV. Blinding will not be used in this trial, as the different interventions cannot be blinded.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
380 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Repeat catheter ablation (CA)
Arm Type
Active Comparator
Arm Title
Varian Cardiac Radioablation (CRA)
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Varian Cardiac Radioablation (CRA)
Intervention Description
Subjects randomized to CRA will be treated with the Varian CRA system according to a uniform CRA protocol. A dose of 25 Gy in a single fraction is prescribed to the planning target volume (PTV), and delivered using a stereotactic body radiotherapy (SBRT) technique.
Intervention Type
Procedure
Intervention Name(s)
Catheter Ablation (CA)
Intervention Description
Subjects randomized to the CA arm will be treated according to a uniform CA protocol.
Primary Outcome Measure Information:
Title
Co-primary safety endpoint: freedom from treatment-attributed (i.e., probably or definitely related) serious adverse events (SAEs)
Description
Freedom from treatment-attributed (i.e., probably or definitely related) serious adverse events (SAEs), evaluated from treatment through 12 months post-treatment.
Time Frame
Treatment through 12 months post-treatment
Title
Co-primary efficacy endpoint: Freedom from death, and appropriate ICD shock, and VT storm.
Description
Freedom from death, and appropriate ICD shock, and VT storm, where death will be counted from randomization through 12 months, and shock and storm will be counted starting after a 30-day period immediately post-randomization and continuing through 12 months post randomization.
Time Frame
Death will be counted from randomization through 12 months, and shock and storm will be counted starting after a 30-day period immediately post-randomization and continuing through 12 months post randomization
Secondary Outcome Measure Information:
Title
Change in quality of life at 6 weeks post treatment:
Description
Change in quality of life at 6 weeks post treatment measured by the Short Form Health Survey 36 (SF-36) Health Change Question. This item asks the subject to rate their health in general compared to one year ago in a 5-point scale of 1 (much better), 2 (somewhat better), 3 (about the same), 4 (somewhat worse), 5 (much worse).
Time Frame
From baseline through 6 weeks post treatment
Title
VT burden reduction
Description
VT burden reduction measured as a ≥75% reduction in appropriate ICD therapies (ATP, shock), comparing a 6-month period before randomization and a 6-month period starting after a 30-day period immediately post-randomization.
Time Frame
From 6 months before randomization through to a 6 month period starting after a 30-day period immediately post-randomization
Title
Change in quality of life (Social Functioning) at 6 weeks post treatment
Description
Change in quality of life (Social Functioning) measured by the Short Form Health Survey 36 (SF-36) Social Functioning item (social activities in past 4 weeks). This item asks the subject to rate how much of the time their physical health or emotional problems interfered with their social activities in the past 4 weeks in a 5-point scale of 1 (All of the time), 2 (Most of the time), 3 (Some of the time), 4 (A little bit of the time), 5 (None of the time).
Time Frame
From baseline through 6 weeks post treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: High-risk refractory VT, defined as: Ischemic and/or nonischemic cardiomyopathy, and Recurrent sustained monomorphic VT, defined as at least one of the following below, documented by ICD interrogation or ECG in the prior 6 months, and having occurred after the last VT ablation: A: ≥3 episodes of monomorphic VT treated with anti-tachycardia pacing (ATP) at least one of which is symptomatic B: ≥1 appropriate ICD shock C: ≥3 episodes of sustained monomorphic VT within 24 hours treated with ICD shock or ATP D: sustained monomorphic VT below detection rate of ICD documented by ECG, and Left ventricular ejection fraction (LVEF) ≤35% and Previously underwent at least one standard of care CA for VT. Presence of a clinical indication for a repeat CA procedure for scar-mediated VT in the judgement of the treating investigator. Has failed amiodarone therapy or is intolerant to amiodarone: Failed amiodarone therapy is defined as: appropriate ICD therapy or sustained monomorphic VT having occurred while the patient was taking amiodarone (minimum cumulative dose of 10 g). Intolerant to amiodarone is defined as: previously tried or taken amiodarone but stopped due to medication related side effects or toxicities. Deemed to be medically and technically a candidate for further CA by the electrophysiologist investigator. Presence of an ICD. At least 18 years of age (or meets local age of majority). Ability to understand and willingness to sign an IRB approved written informed consent document. Exclusion Criteria: Contraindication to a CA procedure for VT (e.g., presence of mobile LV thrombus, active systemic infection, active ischemic or other reversible causes of VT). Any prior radiation to the thorax region of the body. Known medical conditions associated with higher risk of radiotherapy complications in the judgement of the radiation oncologist (i.e., active connective tissue disorders, interstitial lung disease, etc.) that would preclude safe delivery of CRA. Current use of inotropes. Presence of a left-ventricular assist device (LVAD). Scheduled for LVAD or heart transplant procedures. Presence of a systemic illness likely to limit survival to < 1 year. VT ablation procedure performed within the prior 4 weeks. Polymorphic VT or ventricular fibrillation (VF) as the primary clinical heart rhythm, as indicated by 12-lead ECG and/or ICD interrogation. >3 distinct clinical monomorphic VT morphologies on ICD interrogation since the prior CA, or >5 induced monomorphic VT morphologies during NIPS testing. Incessant VT that is hemodynamically unstable. Bundle branch reentry (BBR) VT. Pregnant and/or breastfeeding. (Patient denial is sufficient for enrollment). Patients of childbearing potential who: are not on a medically effective means of birth control at the time of screening or do not start a medically effective means of birth control prior to randomization; or do not agree to continue medically effective means of birth control until they have completed their assigned therapy; or do not agree to be on a medically effective means of birth control if they are treated with CRA after their index CA procedure. Patients enrolled in another clinical study the investigator believes to be in conflict with this clinical investigation. Patients enrolled or planned to be enrolled in another cardiac radioablation clinical study or registry. Patients with any other medical condition or laboratory value that would, at the discretion of the investigator, preclude the patient from participation in this clinical investigation.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Claire McCann, PhD
Phone
437.240.4531
Email
claire.mccann@varian.com
First Name & Middle Initial & Last Name or Official Title & Degree
David J Harrington
Phone
+1 (434) 2422995
Email
david.harrington@varian.com
Facility Information:
Facility Name
Hartford Hospital
City
Hartford
State/Province
Connecticut
ZIP/Postal Code
06102
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Megan Scalzo
Phone
860-972-4268
Email
megan.scalzo@hhchealth.org
First Name & Middle Initial & Last Name & Degree
Jennifer Rossi
Phone
860-972-5311
Email
jennifer.rossi@hhchealth.org
First Name & Middle Initial & Last Name & Degree
Aneesh Tolat, MD
Facility Name
Washington University
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kaitlin Moore
Email
kaitlin.m.moore@wustl.edu
First Name & Middle Initial & Last Name & Degree
Daniel Cooper, MD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Cardiac RADIoablation Versus Repeat Catheter Ablation: a Pivotal Randomized Clinical Trial Evaluating Safety and Efficacy for Patients With High-risk Refractory Ventricular Tachycardia (RADIATE-VT)

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