beta
Trial Radar AI
Clinical Trial NCT05439031 (STARNL-2) for Ventricular Tachycardia, Arrythmia, Cardiac is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here.
One study matched filter criteria
Card View
Back to Search

StereoTactic Arrhythmia Radiotherapy in the NetherLands no. 2 (STARNL-2) Phase 2 12

Recruiting
Clinical Trial NCT05439031 (STARNL-2) is designed to study Treatment for Ventricular Tachycardia, Arrythmia, Cardiac. It is a Phase 2 interventional study that is recruiting, having started on May 19, 2023, with plans to enroll 12 participants. Led by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA), it is expected to complete by July 1, 2027. The latest data from ClinicalTrials.gov was last updated on January 14, 2026.
Brief Summary
Ventricular tachycardia (VT) is a malignant cardiac arrhythmia subjecting our patients to a high risk of sudden death, increased morbidity and reduced quality of life. Unfortunately, failure of treatment is common and VT recurrences remain an important concern. In these patients, stereotactic arrhythmia radiotherapy appears to be an effective and safe treatment. The mechanism of action however remains unknown and sho...Show More
Detailed Description
Ventricular tachycardia (VT) is a malignant cardiac arrhythmia leading to a sudden abolition of cardiac function directly followed by a shortage of oxygen supply to essential organs such as the brain and heart. For this reason, VT is a cardiac emergency and should be treated within seconds to minutes before irreversible and potentially fatal organ damage follows. Current treatment options are limited to anti-arrhythm...Show More
Official Title

StereoTactic Arrhythmia Radiotherapy in the NetherLands no. 2

Conditions
Ventricular TachycardiaArrythmia, Cardiac
Publications
Scientific articles and research papers published about this clinical trial:
Other Study IDs
  • STARNL-2
  • NL80617.018.22
NCT ID Number
NCT05439031
Start Date (Actual)
2023-05-19
Last Update Posted
2026-01-14
Completion Date (Estimated)
2027-07
Enrollment (Estimated)
12
Study Type
Interventional
PHASE
Phase 2
Status
Recruiting
Keywords
Ventricular Arrhythmias
Ventricular Tachycardia
Cardiac Radioablation
Stereotactic Radiotherapy
Stereotactic Arrhythmia Radiotherapy
Stereotactic body radiotherapy
Cardiac ablative radiotherapy
Primary Purpose
Treatment
Design Allocation
N/A
Interventional Model
Single Group
Masking
None (Open Label)
Arms / Interventions
Participant Group/ArmIntervention/Treatment
ExperimentalStereotactic Arrhythmia Radiotherapy
Patients will undergo stereotactic arrhythmia radiotherapy and subsequent follow-up.
Stereotactic Arrhythmia Radiotherapy
Single radiation treatment of 25 Gy with external beam radiation therapy to the pro-arrhythmic region as determined by the cardiologist-electrophysiologist and radiation-oncologist combined
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Reduction in the number of treated VT episodes
The main efficacy measure is a reduction in the number of treated VT episodes by ≥50% at the end of follow-up of 1 year (including a blanking period of 3 months). Net follow-up is 9 months compared to 9 months before treatment.
18 months (excluding 3 months of blanking period)
Rate of treatment related serious adverse events (SAEs)
The main safety measure is defined by a ≤20% rate of treatment related serious adverse events (SAEs), determined as the number of treatment related serious adverse events per number of treatment related adverse events.
12 months
Secondary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Reduction in the number of treated and non-treated VT episodes
Reduction in the number of treated and non-treated VT episodes by ≥70% at the end of follow-up compared to the year before treatment.
18 months (excluding 3 months of blanking period)
Reduction in anti-arrhythmic drugs
A reduction of the daily dose by ≥50% (amiodarone or mexiletine) at the end of follow-up compared to baseline.
12 months
Quality of Life improvement
Quality of life improvement of ≥25% in the categories health change and social functioning as measured by the SF-36 questionnaire at the end of follow-up compared to baseline.
12 months
Cardiac safety
\>25% relative decrease in left ventricular ejection fraction measured by echocardiography at end of follow-up as compared to baseline
12 months
Pulmonary safety
\>25% relative decrease in forced expiratory volume in 1 second (FEV1) measured by pulmonary functions tests at end of follow-up as compared to baseline.
12 months
Pulmonary safety
\>25% relative decrease in diffusing capacity (DLCO) measured by pulmonary functions tests at one year after treatment as compared to baseline
12 months
Participation Assistant
Eligibility Criteria

Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All

  • Age ≥18 years

  • Implanted ICD

  • World Health Organization (WHO) / Eastern Cooperative Oncology Group (ECOG) performance status grade 0-3 in the past 3 months (from fully active to capable of limited self-care, see below for full explanation)

  • At least 3 episodes of treated VT within the last 3 months

  • Recurrence of VT after

    • Failed or intolerant to least one class 1 or class 3 anti-arrhythmic drug AND
    • At least one catheter ablation procedure OR considered to be unsuitable for a catheter ablation procedure (e.g. no sufficient vascular access, considered unfit to undergo prolonged general anesthesia, comorbid conditions resulting in unacceptable peri-procedural risks)

  • Able and willing to undergo all necessary evaluations, treatment and follow-up for the study and of follow-up thereafter

  • Pregnancy
  • History of radiation treatment in the thorax or upper abdominal region
  • Interstitial pulmonary disease
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) logoAcademisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Dutch Heart Foundation logoDutch Heart Foundation
Study Responsible Party
Pieter G. Postema, Principal Investigator, Principal investigator, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Study Central Contact
Contact: Pieter G Postema, MD PhD, 0031 20 566 4338, [email protected]
1 Study Locations in 1 Countries

North Holland

Amsterdam UMC location University of Amsterdam, Amsterdam, North Holland, 1105AZ, Netherlands
Pieter G Postema, MD PhD, Contact, 0031 20 566 4338, [email protected]
Recruiting