Clinical Study of the HeartLight X3 Endoscopic Ablation System With Excalibur Balloon

Not Applicable

Completed

• Conditions: Atrial Fibrillation

• 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

Study Timeline

• Study Start: 2018-02-15
• Study First Submitted: 2018-03-06
• Study First Submitted QC: 2018-03-19
• Study First Posted: 2018-03-20
• Primary Completion: 2018-11-15
• Study Completion: 2020-01-16
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-05
• Last Update Posted: 2021-02-08

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

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
PAE Rate	30 Days	Primary Adverse Event rate
AF Free Rate	6 and 12 months	6- and 12-month chronic results
PV Isolation	Acute - at the end of the index procedure	Percent of isolated pulmonary veins

Trial Locations

Locations (1)

Nemocnice Na Homolce; 🇨🇿 Prague, Czechia