Clinical Study of the HeartLight X3 Endoscopic Ablation System With Excalibur Balloon
Not Applicable
Completed
- Conditions
- Atrial Fibrillation
- Interventions
- Device: HeartLight X3
- Registration Number
- NCT03470636
- Lead Sponsor
- CardioFocus
- Brief Summary
The objective of the study is to demonstrate the improved ablation and procedure times of the HeartLight X3 compared to the current HeartLight catheter in the treatment of atrial fibrillation.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 60
Inclusion Criteria
- paroxysmal atrial fibrillation failure of at least one AAD others
Exclusion Criteria
- overall good health as established by multiple criteria
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description HeartLight X3 HeartLight X3 Pulmonary vein isolation using HeartLight X3
- Primary Outcome Measures
Name Time Method Ablation time Acute - at the end of the index procedure Ablation time
- Secondary Outcome Measures
Name Time Method Procedure time Acute - at the end of the index procedure Procedure time
PV Isolation Acute - at the end of the index procedure Percent of isolated pulmonary veins
PAE Rate 30 Days Primary Adverse Event rate
AF Free Rate 6 and 12 months 6- and 12-month chronic results
Trial Locations
- Locations (1)
Nemocnice Na Homolce
🇨🇿Prague, Czechia