HeartLight X3 Endoscopic Ablation System With Excalibur Balloon for Treatment of Symptomatic Persistent AF

Atrial Fibrillation Clinical Trial

Official title:

Clinical Study of the HeartLight X3 Endoscopic Ablation System (EAS) With Excalibur Balloon Compared to HeartLight System in the Treatment of Symptomatic Persistent Atrial Fibrillation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03988244
• Other study ID #: 25-4911
• Status: Completed
• Phase: N/A
• Start date: February 26, 2019
• Est. completion date: April 3, 2020

Study information

• Verified date: July 2021
• Source: CardioFocus
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11
• Est. completion date: April 3, 2020
• Est. primary completion date: April 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• early persistent AF, failure of at least one AAD, others

Exclusion Criteria:

• overall good health as established by multiple criteria

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Device:
• HeartLight X3
Pulmonary vein isolation

Locations

Country	Name	City	State
Czechia	Nemocnice Na Homolce	Prague

Sponsors (1)

Lead Sponsor	Collaborator
CardioFocus

Country where clinical trial is conducted

Czechia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ablation time	Ablation time	Acute - at the end of the index procedure
Secondary	Procedure time	Procedure time	Acute - at the end of the index procedure
Secondary	PV Isolation	Percent of isolated pulmonary veins	Acute - at the end of the index procedure
Secondary	PAE Rate	Primary Adverse Event rate	30 Days
Secondary	AF Free Rate	6- and 12-month chronic results	6 and 12 months