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StereoTactic Arrhythmia Radiotherapy in the NetherLands no. 1

StereoTactic Arrhythmia Radiotherapy in the NetherLands no. 1

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON22142
Enrollment
6
Registered
2019-02-04
Start date
2019-04-01
Completion date
Unknown
Last updated
2024-06-11

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

Conditions

Ventricular tachycardia

Interventions

The pro-arrhythmic cardiac region is identified by combining anatomical imaging with non-invasive body surface potential mapping during VT induction with non-invasive programmed stimulation. Radiother

Sponsors

Amsterdam University Medical Centers
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1 Age >18 years 2 Implanted ICD 3 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) 4 At least 3 episodes of treated VT within the last 3 months 5 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) 6 Able and willing to undergo all necessary evaluations, treatment and follow-up for the study and of follow-up thereafter 7 Informed consent

Exclusion criteria

Exclusion criteria: 1 Pregnancy 2 History of radiation treatment in the thorax or upper abdominal region 3 Interstitial pulmonary disease 4 Renal insufficiency with a glomerular filtration rate <30ml/min 5 Refusal or inability to provide informed consent or to undergo all necessary evaluations, treatment and follow-up for the study

Design outcomes

Primary

MeasureTime frame
The main efficacy measure is a reduction in the number of ICD treated VT episodes by =50% at one year after treatment compared to the year before treatment.

Secondary

MeasureTime frame
The secondary outcome measure is a =50% reduction in daily dose class 1 and 3 anti-arrhythmic drugs at one year after treatment as compared to baseline

Contacts

Public ContactP.G. Postema

Amsterdam UMC, location AMC

p.g.postema@amc.uva.nl020 566 9111

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)