CArdiac STereotactic Radiation Treatment for Ablation of ventRicular Tachycardia (CASTAR)
The investigator-initiated, CArdiac Stereotactic radiation Treatment for Ablation of ventRicular tachycardia (CASTAR) study will be conducted in patients with ventricular tachycardia (VT) which is either refractory to antiarrhythmic medication therapy in maximal dose or to catheter ablation or with contraindications to antiarrhythmic medication or catheter ablation.
The study is a non-randomized, multicenter, interventional study of cardiac SBRT, for which a total dose of 25 Gy will be delivered in a single fraction using volumetric modulated arc therapy (VMAT). The aim of the CASTAR study is to assess the feasibility and the safety of cardiac SBRT for the treatment of VT. Secondary objectives are efficacy, toxicity and QoL of cardiac SBRT for Ventricular tachycardia .
연구 개요
상태
상태
정황
정황
개입 / 치료
개입 / 치료
상세 설명
The study will be conducted at multiple centers across Belgium. Twenty patients will be enrolled to the study. Interim analyses are planned to be performed when the first five or ten subjects have been treated. Participation in the study will comprise a screening period, where screening assessments must be completed before starting treatment. Eligible, consenting patients will then undergo SBRT, which is limited to a single dose delivery on one day. During SBRT, patients are closely monitored in accordance with the DEGRO guidelines for radiotherapy in patients with ICDs (Gauter-Fleckenstein 2015). After SBRT, patients will be closely monitored during a 3-5 days hospitalization. The post-treatment phase will start after patients are discharged from the hospital. Patients will be followed on regular basis to assess safety and efficacy of SBRT treatment.
연구 유형
연구 유형
등록 (추정된)
등록
단계
단계
- 해당 없음
연락처 및 위치
연구 장소
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Belgium
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Antwerp, Belgium, 벨기에, 2610
- 모병
- ZAS Augustinus
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연락하다:
- Ines Joye, PhD
- 전화번호: +32 3 443 37 37
- 이메일: ines.joye@zas.be
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수석 연구원:
- Ines Joye, PhD
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Edegem, Belgium, 벨기에, 2600
- 모병
- UZA
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연락하다:
- Johan Saenen, PhD
- 전화번호: + 32 3 821 53 16
- 이메일: johan.saenen@uza.be
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수석 연구원:
- Johan Saenen, PhD
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-
참여기준
자격 기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Patients over the age of 18 with structural heart disease
- Patients with ventricular tachycardia requiring intervention (e.g. an electrical shock or anti-tachycardia pacing via an Implantable Cardioverter Defibrillator (ICD)) which cannot be managed with medication or catheter ablation, or where there are contraindications to treatment with medication or catheter ablation.
- Contraindications may exist due to comorbidities or due to the type or severity of the disease.
- Informed consent to participate has been obtained from the patient or from his or her legal representative.
Exclusion Criteria:
- Lack of evidence that the ventricular tachycardia is triggered by myocardial scarring (based on MRI, CT EAM).
- Any contraindication to radiosurgery (e.g. inability to precisely define the target volume due to imaging artefacts caused by an LVAD)
- Pregnancy
- Previous radiotherapy that prevents the safe delivery of the dose.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
팔의 수
무기와 개입
참가자 그룹 / 팔참가자 그룹 / 팔 |
개입 / 치료개입 / 치료 |
|---|---|
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실험적: SBRT
A single radiation dose of 25 Gy is delivered to the VT target. |
Stereotactic body radiation therapy (SBRT): a single radiation dose of 25 Gy is delivered to the VT target. |
연구는 무엇을 측정합니까?
주요 결과 측정
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Feasibility of SBRT for the treatment of ventricular tachycardia
기간: Day of SBRT treatment (Day 1)
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Feasibility will be assessed as the successful implementation and completion of cardiac SBRT without interruption of treatment. SBRT consists of a single fraction of 25 Gy delivered to the ventricular tachycardia target. |
Day of SBRT treatment (Day 1)
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|
Safety of SBRT for the treatment of ventricular tachycardia.
기간: From SBRT treatment through 31 days after SBRT
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Safety will be assessed by the incidence and severity of adverse events related to radiotherapy following cardiac SBRT. Adverse events will be assessed and graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 5.0. |
From SBRT treatment through 31 days after SBRT
|
2차 결과 측정
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change in ventricular tachycardia burden following SBRT
기간: 6 months before SBRT through 6 months after SBRT
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The ventricular tachycardia (VT) burden will be assessed by the number of VT episodes recorded by ECG and implantable cardioverter-defibrillator (ICD) readouts. The number of VT episodes during the 6 months following SBRT will be compared with the number during the 6 months preceding SBRT. A 6-week blanking period immediately following SBRT will be taken into account in the analysis of VT recurrences. |
6 months before SBRT through 6 months after SBRT
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Time from SBRT to first VT recurrence
기간: From SBRT through 36 months after treatment
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Time from SBRT treatment to the first documented recurrence of ventricular tachycardia, as determined from ICD readouts. A 6-week blanking period following SBRT will be considered in the analysis of VT recurrence. |
From SBRT through 36 months after treatment
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Time from SBRT to first sustained ventricular tachycardia or ICD shock
기간: From SBRT through 36 months after treatment
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Time from SBRT treatment to the first occurrence of sustained ventricular tachycardia or the first appropriate ICD shock during follow-up. |
From SBRT through 36 months after treatment
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Time from SBRT to first ventricular tachycardia storm
기간: From SBRT through 36 months after treatment
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Time from SBRT treatment to the first occurrence of a ventricular tachycardia storm during follow-up. |
From SBRT through 36 months after treatment
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Change in the number of electrical storms following SBRT
기간: 6 months before SBRT through 6 months after SBRT
|
The number of electrical storms occurring following SBRT will be compared with the number occurring before SBRT treatment. |
6 months before SBRT through 6 months after SBRT
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Change in anti-tachycardia pacing and ICD shocks following SBRT
기간: 6 months before SBRT through 6 months after SBRT
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The number of anti-tachycardia pacing (ATP) interventions and ICD shocks following SBRT will be compared with the number occurring before SBRT treatment. |
6 months before SBRT through 6 months after SBRT
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Change in anti-arrhythmic medication use following SBRT
기간: From baseline through 36 months after SBRT
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Anti-arrhythmic medication use will be assessed during follow-up. The type and dosage of anti-arrhythmic drugs will be collected to evaluate changes in the need for anti-arrhythmic treatment following SBRT. |
From baseline through 36 months after SBRT
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Overall survival following SBRT
기간: From SBRT through 36 months after treatment
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Overall survival will be assessed from the date of SBRT treatment until death from any cause. |
From SBRT through 36 months after treatment
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Incidence of heart transplantation following SBRT
기간: From SBRT through 36 months after treatment
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The number and proportion of participants requiring heart transplantation during follow-up will be assessed. |
From SBRT through 36 months after treatment
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Incidence of cardiac arrhythmic mortality following SBRT
기간: From SBRT through 36 months after treatment
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The number and proportion of participants who die from a cardiac arrhythmic cause during follow-up will be assessed. |
From SBRT through 36 months after treatment
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Incidence of cardiac non-arrhythmic mortality following SBRT
기간: From SBRT through 36 months after treatment
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The number and proportion of participants who die from a cardiac non-arrhythmic cause during follow-up will be assessed. |
From SBRT through 36 months after treatment
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Incidence and severity of acute radiation-related adverse events
기간: Through 90 days after SBRT
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The incidence and severity of adverse events related to radiotherapy will be assessed and graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 5.0. Acute adverse events are defined according to the time period specified in the protocol. |
Through 90 days after SBRT
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Incidence and severity of late radiation-related adverse events
기간: The protocol defines late adverse events as those occurring more than 90 days after starting radiotherapy.
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The incidence and severity of late adverse events related to radiotherapy will be assessed and graded according to NCI CTCAE version 5.0. |
The protocol defines late adverse events as those occurring more than 90 days after starting radiotherapy.
|
공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
연구 시작
기본 완료 (추정된)
기본 완료
연구 완료 (추정된)
연구 완료
연구 등록 날짜
최초 제출
최초 제출
QC 기준을 충족하는 최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
처음 게시됨
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
마지막 업데이트 게시됨
QC 기준을 충족하는 마지막 업데이트 제출
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
기타 연구 ID 번호
- CTO22012GZA
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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