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StereoTactic Arrhythmia Radiotherapy in the NetherLands no. 2

Status: Recruiting
Location: See location...
Intervention Type: Radiation
Study Type: Interventional
Study Phase: Phase 2
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 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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Netherlands
Amsterdam UMC location University of Amsterdam
RECRUITING
Amsterdam
Contact Information
Primary
Pieter G Postema, MD PhD
p.g.postema@amsterdamumc.nl
0031 20 566 4338
Time Frame
Start Date: 2023-05-19
Estimated Completion Date: 2027-07
Participants
Target number of participants: 12
Treatments
Experimental: Stereotactic Arrhythmia Radiotherapy
Patients will undergo stereotactic arrhythmia radiotherapy and subsequent follow-up.
Related Therapeutic Areas
Sponsors
Collaborators: Dutch Heart Foundation
Leads: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

This content was sourced from clinicaltrials.gov

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