Cardiac Radioablation for Ventricular tachycardia

Clinical feasibility study of Noninvasive Cardiac Radio-ablation for Treatment of Ventricular tachycardia

Status

Active, not recruiting

Phases

Phase 1Phase 2

Study type

Interventional

Source

CRIS

Registry ID

KCT0004302

Enrollment

Registered

2019-10-11

Start date

2019-08-29

Completion date

Unknown

Last updated

2024-03-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Radiation : Radiation therapy on ventricular tachycardia focus 25Gy, single fraction

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Documented ventricular tachycardia [1] Symptomatic ventricular tachycardia over 2 times on 12-leads ECG, Rhythm strip or implantable devices, within recent 6 months [2] ICD therapy (shock or ATP) within 6 months [3] In the case of PVC induced heart failure (LVEF <50%): PVC burden is over 15% on holter monitoring 2) Failed standard therapy for ventricular tachycardia [1] Patients who are unable to adapt to antiarrhythmic medications or whose ventricular tachycardia is uncontrolled even after 2 months of adequate treatment --AND-- [2] Previous failed catheter ablation for ventricular tachycardia or were not suitable for catheter ablation (left ventricular thrombosis, severe lung disease, vascular abnormality, heart malformation, etc.) 3) Those whose life expectancy is expected to decrease due to ventricular tachycardia (required by the expert cardiologist) 4) Left ventricular ejection function = 15% 5) Functional class: NYHA class = II 6) 19 years old or older

Exclusion criteria

Exclusion criteria: 1) Those who do not agree to study registration 2) Those whose radiation therapy is not medically appropriate -When a suitable posture for radiation therapy is not possible -Others who are judged unsuitable by the judgment of radiation oncologist. 3) Those who have an extracorporeal circulatory system (ECMO) or left ventricular assist device or who require high-dose inopropics due to a cause other than ventricular tachycardia, (if the dose of Dopamine or Dobutamine is higher than 10 mcg / kg / min) 4) Life expectancy is less than 12 months, even if there is no ventricular tachycardia due to other diseases. 5) Pregnant or breast feeding

Design outcomes

Primary

Measure	Time frame
Acute safety;Efficacy outcome	—

Secondary

Measure	Time frame
Overall mortality;Late toxicity;Health related quality of life: HRQOL;Stricter efficacy (50% reduction);Stricter efficacy (95% reduction);Clinically important treatment efficacy (ICD treatment frequency or LVEF improvement);Long-term durability	—

Countries

Korea, Republic of

Contacts

Public ContactMyung-Jin Cha

Seoul National University Hospital

cmj.with.love@gmail.com@gmail.com+82-2-2072-4780

Outcome results