Health TrialsbyHealthPanel

StereoTactic Arrhythmia Radiotherapy in the NetherLands no. 2

ConditionsVentricular TachycardiaArrythmia, Cardiac
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorAcademisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

About this trial

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 should be elucidated.

The objective of this phase 2, single arm, monocenter, pre-post intervention study is to evaluate the efficacy and safety of stereotactic arrhythmia radiotherapy and obtain insights in the mechanism of action by evaluating electro-anatomical alterations of stereotactic arrhythmia radiotherapy in patients with therapy refractory ventricular tachycardia.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Pregnancy

History of radiation treatment in the thorax or upper abdominal region

Interstitial pulmonary disease

Trial design

Design model

Single group

Treatments tested in this trial

  • Stereotactic Arrhythmia Radiotherapy

    Radiation

    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

Treatment groups

12 Participants
are divided into 1 treatment group
Group A: Stereotactic Arrhythmia RadiotherapyExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
18 months (excluding 3 months of blanking period)
2

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.

Time frame
12 months

Secondary outcomes

1

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.

Time frame
18 months (excluding 3 months of blanking period)
2

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.

Time frame
12 months
3

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.

Time frame
12 months
4

Cardiac safety

\>25% relative decrease in left ventricular ejection fraction measured by echocardiography at end of follow-up as compared to baseline

Time frame
12 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Lead sponsor

Dutch Heart Foundation

Collaborator

Source ClinicalTrials.gov
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