Stereotactic Radio-regulation Antiarrhythmic Therapy trial

Phase 2

Recruiting

• Conditions: Intractable Ventricular Arrhythmia

• Registration Number: JPRN-jRCTs032190041
• Lead Sponsor: Yoshioka Koichiro

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-06-19
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 8

Inclusion Criteria

Eligible patients had more than 3 episodes of sustained monomorphic VT or cardiomyopathy* (left ventricular ejection fraction less than 50%) related to monomorphic premature ventricular contractions (PVCs beyond 20%) and required failure of more than 1 antiarrhythmic medication and more than 1 catheter ablation (or had a contraindication to catheter ablation such as anatomical difficulty or epicardial origin, or patient's rejection**). Patients could not have received past radiotherapy to the anticipated treatment field.
*Cardiomyopathy can be ischemic or non-ischemic (idiopathic, contractile pericarditis, valvular disease, etc.)
**Even if two independent cardiologists give enough explanation, it is assumed that the patient's informed consent was not obtained.

Exclusion Criteria

Patients were deemed ineligible if they had heart failure dependent on inotropes or a left-ventricular assist device or were deemed unlikely to live 12 months in the absence of VT. Patients were also ineligible if they had polymorphic VT or ventricular fibrillation, beyond 3 distinct clinical VT morphologies, or beyond 5 induced VT morphologies during noninvasive-programmed stimulation testing by using ICD.

Even if the above selection criteria and exclusion criteria are met, patients who fall under any of the following conditions are excluded
1. Maintenance hemodialysis or peritoneal dialysis is performed.
2. Organic heart disease requiring surgical treatment.
3. Hospitalization is required for acute coronary syndrome or acute heart failure.
4. High risk of radiation pneumonitis, eg evidence of idiopathic pulmonary fibrosis on chest CT.
5. The research investigator or associate physician judges that participation in this study is inappropriate. For example, it may be considered difficult to carry out necessary tests and follow-up due to other diseases or reasons.

Study & Design

• Study Type: Interventional
• Study Design: Not specified