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Post-Market Clinical Study of the CardioFocus Endoscopic Ablation System - Adaptive Contact (CF-EAS-AC) for the Treatment of Symptomatic Atrial Fibrillation

Post-Market Clinical Study of the CardioFocus Endoscopic Ablation System - Adaptive Contact (CF-EAS-AC) for the Treatment of Symptomatic Atrial Fibrillation

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01196923
Enrollment
20
Registered
2010-09-09
Start date
2010-09-30
Completion date
2012-06-30
Last updated
2016-07-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atrial Fibrillation

Brief summary

The purpose of this study is to confirm the safety and effectiveness of the CardioFocus Endoscopic Ablation System with Adaptive Contact in the treatment of atrial fibrillation.

Interventions

DEVICEEndoscopically Guided Ablation

Visually Guided Ablation using EAS-AC

Sponsors

CardioFocus
Lead SponsorINDUSTRY

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

Inclusion criteria

* Symptomatic, Paroxysmal Atrial Fibrillation (AF) * 18 to 70 Years of age * Others

Exclusion criteria

* Generally good overall health as determined by multiple criteria * Willing to participate in a study * Others

Design outcomes

Primary

MeasureTime frameDescription
Acute Isolation of Pulmonary Veins.Acute PVI measured on the day of treatment99% of pulmonary veins were isolated (72/73)

Countries

Italy

Participant flow

Participants by arm

ArmCount
HeartLight Ablation
Pulmonary Vein Isolation with the HeartLight System. Participants with data available are reported so that not all measures may include data from 20 participants.
20
Total20

Baseline characteristics

CharacteristicHeartLight Ablation
Age, Customized
Average age, reported data
59 years
Gender
Female
3 participants with data available
Gender
Male
16 participants with data available
Region of Enrollment
Italy
20 participants

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
— / —
other
Total, other adverse events
0 / 20
serious
Total, serious adverse events
1 / 20

Outcome results

Primary

Acute Isolation of Pulmonary Veins.

99% of pulmonary veins were isolated (72/73)

Time frame: Acute PVI measured on the day of treatment

Population: All treated participants with reported data.

ArmMeasureValue (NUMBER)
HeartLight Acutely Isolated Pulmonary VeinsAcute Isolation of Pulmonary Veins.99 percent isolated pulmonary veins

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026