STereotactic Ablative Radiosurgery of Recurrent Ventricular Tachycardia in Structural Heart Disease

Launched by UNIVERSITY HOSPITAL OSTRAVA · Oct 27, 2020

Keywords

ClinConnect Summary

This clinical trial is studying a treatment called stereotactic ablative radiosurgery for patients who have recurrent ventricular tachycardia (VT), a fast heart rhythm that can be dangerous, especially in those with existing heart conditions. The trial aims to see how effective this new method is in managing VT for patients who have already had at least one procedure to treat their condition but are still experiencing episodes of VT. The study is currently looking for participants at various medical centers.

To be eligible for this trial, participants must have structural heart disease, which means there are changes in the heart's structure that can affect its function. They should also have an implanted device like a defibrillator to help manage their heart rhythm and have had prior catheter ablation treatments for VT. The trial is open to adults over 20 years old, but those with certain serious health issues or recent heart procedures may not qualify. If you join the trial, you can expect close monitoring and support as researchers evaluate the safety and effectiveness of this innovative treatment approach.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Patients with structural heart disease (SHD) of any etiology (ischemic, non-ischemic, congenital corrected or uncorrected)
• • 2. Implanted implantable cardioverter-defibrillator (ICD) or cardiac resynchronization therapy-defibrillator (CRT-D)
• 3. Prior ≥1 catheter ablation procedure for VT due to SHD of them the last one performed in the expert center and employed:
• • 3.1 all meaningful mapping/ablation approaches (endocardial/epicardial access to left / right ventricular substrate as possible or appropriate) 3.2 precise electroanatomical mapping of the arrhythmogenic substrate in anticipation of future radiosurgery 3.3 additional mapping of structures used for precise image integration (aortic arch, left main ostium, right ventricular endocardial surface)
• 4. VT recurrence after the last catheter ablation fulfilling all criteria as follows:
• • 4.1 clinically relevant and requiring further intervention 4.2 compatible with the previously characterized arrhythmogenic substrate 4.3 occurred on stable antiarrhythmic medication (mostly amiodarone) unless contraindicated 4.4 reversible cause excluded
• • 5. Signed an Institutional Review Board (IRB)-approved written informed consent
• Exclusion Criteria:
• • 1. Age \< 20 years
• • 2. Acute coronary syndrome or recent percutaneous coronary intervention or cardiac surgery (\< 3 months)
• • 3. Primary electrical disease (channelopathy)
• • 4. Pregnancy or breastfeeding
• • 5. Chronic heart failure with New York Heart Association (NYHA) Class IV
• • 6. Serious comorbidities with presumed life expectancy less than one year
• • 7. Significant peripheral artery disease precluding retrograde aortic mapping