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OpenTrials
Completed

NCT Number: NCT03470636

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

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.

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Key information

Conditions

Atrial Fibrillation Arrhythmias, Cardiac Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Nemocnice Na Homolce

Prague, Czechia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • paroxysmal atrial fibrillation failure of at least one AAD others

Exclusion criteria

  • overall good health as established by multiple criteria

Treatment and study plan

HeartLight X3

Device

Pulmonary vein isolation

Primary outcomes

  1. Ablation time

    Time frame: Acute - at the end of the index procedure

    Ablation time

Secondary outcomes

  1. Procedure time

    Time frame: Acute - at the end of the index procedure

    Procedure time

  2. PV Isolation

    Time frame: Acute - at the end of the index procedure

    Percent of isolated pulmonary veins

  3. PAE Rate

    Time frame: 30 Days

    Primary Adverse Event rate

  4. AF Free Rate

    Time frame: 6 and 12 months

    6- and 12-month chronic results

Sponsors and collaborators

Lead sponsor

CardioFocus

Industry

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2018
Study completion
2020
First posted
Mar 20, 2018
Registry last updated
Feb 8, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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