Status:
UNKNOWN
StereoTactic Arrhythmia Radiotherapy in the NetherLands no. 2
Lead Sponsor:
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Collaborating Sponsors:
Dutch Heart Foundation
Conditions:
Ventricular Tachycardia
Arrythmia, Cardiac
Eligibility:
All Genders
18+ years
Phase:
NA
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 treatm...
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 ...
Eligibility Criteria
Inclusion
- 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
Exclusion
- Pregnancy
- History of radiation treatment in the thorax or upper abdominal region
- Interstitial pulmonary disease
Key Trial Info
Start Date :
May 19 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2025
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT05439031
Start Date
May 19 2023
End Date
July 1 2025
Last Update
June 8 2023
Active Locations (1)
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1
Amsterdam UMC location University of Amsterdam
Amsterdam, North Holland, Netherlands, 1105AZ