HeartLight X3 Endoscopic Ablation System With Excalibur Balloon for Treatment of Symptomatic Persistent AF
Not Applicable
Completed
- Conditions
- Atrial Fibrillation
- Registration Number
- NCT03988244
- 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 original HeartLight catheter in the treatment of persistent atrial fibrillation.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 11
Inclusion Criteria
- early persistent AF, 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
- Primary Outcome Measures
Name Time Method Ablation time Acute - at the end of the index procedure Ablation time
- Secondary Outcome Measures
Name Time Method 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
Procedure time Acute - at the end of the index procedure Procedure time
Trial Locations
- Locations (1)
Nemocnice Na Homolce
🇨🇿Prague, Czechia
Nemocnice Na Homolce🇨🇿Prague, Czechia