Ablation of Supraventricular Arrhythmias With As Low As Reasonably Achievable X-Ray Exposure
Recruiting
- Conditions
- Tachycardia, Supraventricular
- Registration Number
- NCT04716270
- Lead Sponsor
- Mohamed Bin Khalifa Bin Sulman Al Khalifa Cardiac Centre
- Brief Summary
Observational study is to demonstrate a clinically significant reduction of ionizing radiation exposure during transcatheter ablation of supraventricular tachycardias using the EnSite precision mapping system in a real-world clinical setting without compromising efficacy and safety.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 700
Inclusion Criteria
- Male or female patients ≥ 18 years of age
- Patient indicated for supraventricular arrhythmias ablation according to the current guidelines
- Patient is willing to provide written informed consent.
Exclusion Criteria
- Patient is pregnant.
- Contraindications to ionizing radiation exposure
- Patient's life expectancy is less than 1 year
- Associated complex congenital heart disease
- Cardiac implantable electric devices
- Known pathological venous access to the heart
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Incidence of procedure related cardiac Adverse Events (Safety) 6 months Cardiac related serious adverse events frequency during and after ablation procedure of supraventricular arrhythmias
Radiation exposure dose The day of performing the procedure The dose of ionizing radiation exposure in patients undergoing Supraventricular Tachycardia catheter ablation utilizing a non-fluoroscopic EnSite Precision 3D mapping system
- Secondary Outcome Measures
Name Time Method Fluoroscopy time The day of performing the procedure Fluoroscopy time during the procedure
Trial Locations
- Locations (1)
Mohamed Bin Khalifa Cardiac Center
🇧🇭Ar Rifā', Bahrain