Cardiac RadiothErapy for VEntricular Tachycardia II

Recruiting

• Conditions: Ventricular Tachycardia (VT)

• Registration Number: NCT06744530
• Lead Sponsor: Universitaire Ziekenhuizen KU Leuven

Brief Summary

Steoreotactic therapy radioablation has become a standard of care option for patients with therapy-refractory ventricular tachycardia, yet long-term outcome is lacking. The objective of this study is to evaluate the long-term outcomes, both efficacy and safety, after STAR in patients with therapy-refractory ventricular tachycardia.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-12
• Study First Submitted: 2024-12-16
• Study First Submitted QC: 2024-12-16
• Study First Posted: 2024-12-20
• Study Start: 2025-01-01
• Last Update Submitted: 2025-01-06
• Last Update Posted: 2025-01-07
• Primary Completion: 2033-12
• Study Completion: 2034-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• Eligible for STAR for therapy-refractory VT based on a multidisciplinary discussion
• Ability to give a written informed consent and willingness to return for follow-up

Exclusion Criteria

• Contra-indications for STAR, including pregnancy or breastfeeding, previous radiotherapy with cardiac involvement, life-expectancy < 6 months in the absence of VT
• Any condition that is deemed a contraindication in the judgment of the investigators

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in VT burden	48 months	Change in VT burden, measured as the frequency of appropriate ICD interventions or documented VT episodes over a 48-month follow-up period. The ICD interrogations are part of standard of care and the majority of patients are included in remote monitoring which automatically sends new VT episodes to the telemonitoring team. The efficacy of STAR will be assessed by analysing both the total VT burden, but also time to first VT event (with and without a 6 week blanking period).

Secondary Outcome Measures

Name	Time	Method
Quality of Life	Baseline and at each follow-up moment: 1 month, 2 months, 3 months, 6 months, 12 months, 24 months, 36 months, 48 months	The 36-Item Short Form Survey (SF-36) is a set of generic, coherent, and easily administered quality of life measures that rely on patient self-reporting. The SF-36 evaluates 8 domains: physical functioning, bodily pain, role limitations due to physical health problems, role limitations due to personal or emotional problems, emotional well-being, social functioning, energy/fatigue, and general health perceptions. Scale values for each domain range from 0 to 100 where the higher score defines a more favorable health state over a 48-month follow-up period.
All-cause mortality	48 months	Survival will be tracked during the 48-month follow-up period. In case of mortality, the cause of death will be registered.
Radiotherapy toxicity	48 months	The tolerable acute toxicity rate is defined as a 30-days follow-up without treatment-related grade ≥ 3 adverse events. Late toxicity is defined as toxicity occurring after at least 30 days after the radiation treatment. Toxicity will be assessed by the Common Terminology Criteria for Adverse Events version 5.0 (CTCAE v5.0).
Left ventricular function	Baseline and at each follow-up moment: 1 month, 2 months, 3 months, 6 months, 12 months, 24 months, 36 months, 48 months	Left ventricular function on transthoracic echocardiogram (TTE) by measuring left ventricular ejection fraction.
Evolution of valve disease	Baseline and at each follow-up moment: 1 month, 2 months, 3 months, 6 months, 12 months, 24 months, 36 months, 48 months	Change of pre-existing or new valve stenosis and insufficiency expressed as grade 0 / I / II / III / IV on transthoracic echocardiogram (TTE).
Change of coronary artery disease	Baseline, 2 years and 4 years	Presence and extent of coronary artery disease on CT coronary angiogram at 2 and 4 years follow-up using the calcium score and CAD-RADs stage.

Trial Locations

Locations (1)

UZ Leuven; 🇧🇪 Leuven, Belgium