Application of High Power Radio Frequency Energy in the Ventricular Tachycardia Treatment

Completed · Not applicable

Conditions studied: Ventricular Tachycardia, Heart Diseases

In brief

Background: Patient's freedom from VT after RFA remains non-optimal and it depends on many factors. One of them is the effective reduction of the myocardium with RF energy during the operation. The standardization of the parameters of RF will help to increase the success of the procedure. Hypothesis: Radiofrequency ablation of ventricular tachycardias with high power parameters has comparable safety and leads to greater efficacy (absence of ventricular tachycardias and all types of cardioverter-defibrillator therapies) in the long-term compared with ablation with standard parameters in patients with structural heart disease. Purpose: to evaluate the safety and the efficiency of ablation of ventricular tachycardia in patients with structural heart disease using high power RF energy.

Key facts

Study ID

NCT04657705

Run by

Federal Research Clinical Center of Federal Medical & Biological Agency, Russia

People needed

119

Starts

2020-12-05

Expected to finish

2023-01-27

Last updated by the study team

2023-01-30

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients after myocardial infarction (at least 3 months before enrollment in the study)
• Stable, documented, monomorphic VT, confirmed by ECG and / or CMECG and / or EGM of any implanted device, having appropriate rhythm discrimination algorithms
• Patients who have signed the informed consent

You may not qualify if…

• Acute myocardial ischemia
• A reversible cause of VT (e.g. drug arrhythmia), recently(up to 30 days) suffered from acute coronary syndrome, coronary revascularization (<90 days for bypass surgery, <30 days for percutaneous coronary intervention), or having functional class IV angina.
• Thrombosis of the left ventricle
• Patients who have been implanted the mechanical prostheses in the aortic and mitral positions.
• Patients who have been performed the catheter RFA for VT.
• Renal failure (creatinine clearance <15 ml / min),
• Patients with NYHA functional class IV heart failure
• Patients with a medical condition that may limit survival to less than 1 year
• Patients with myocardial infarction with ST-segment elevation or MI without ST-segment elevation, transferred less than 30 days ago.
• Patients who haven't signed the informed consent

Where it is running

• Texas Cardiac Arrhythmia Institute — Austin, Texas, United States
• Heart and Vascular Center — Bad Bevensen, Germany
• Federal Research Clinical Center of Federal Medical & Biological Agency — Moscow, Russia
• National Medical Research Center of Surgery named after A. Vishnevsky — Moscow, Russia
• I.M. Sechenov First Moscow State Medical University — Moscow, Russia
• National Medical Research Center of Cardiology — Moscow, Russia
• Meshalkin National Medical Research Center — Novosibirsk, Russia

Full record on ClinicalTrials.gov

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