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

NCT ID: NCT03988244

Last Updated: 2021-07-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

11 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-02-26

Study Completion Date

2020-04-03

Brief Summary

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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

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Conditions

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Atrial Fibrillation

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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HeartLight X3

Pulmonary vein isolation using HeartLight X3

Group Type EXPERIMENTAL

HeartLight X3

Intervention Type DEVICE

Pulmonary vein isolation

Interventions

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HeartLight X3

Pulmonary vein isolation

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* overall good health as established by multiple criteria
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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CardioFocus

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Burke T. Barrett

Role: STUDY_DIRECTOR

CardioFocus, Inc.

Locations

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Nemocnice Na Homolce

Prague, , Czechia

Site Status

Countries

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Czechia

Other Identifiers

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25-4911

Identifier Type: -

Identifier Source: org_study_id

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