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

February 5, 2021 updated by: CardioFocus

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Czechia
      • Prague, Czechia
        • Nemocnice Na Homolce

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • paroxysmal atrial fibrillation failure of at least one AAD others

Exclusion Criteria:

  • overall good health as established by multiple criteria

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: HeartLight X3
Pulmonary vein isolation using HeartLight X3
Device: HeartLight X3
Pulmonary vein isolation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ablation time
Time Frame: Acute - at the end of the index procedure
Ablation time
Acute - at the end of the index procedure

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

CardioFocus

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

February 15, 2018

Primary Completion (ACTUAL)

November 15, 2018

Study Completion (ACTUAL)

January 16, 2020

Study Registration Dates

First Submitted

March 6, 2018

First Submitted That Met QC Criteria

March 19, 2018

First Posted (ACTUAL)

March 20, 2018

Study Record Updates

Last Update Posted (ACTUAL)

February 8, 2021

Last Update Submitted That Met QC Criteria

February 5, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 25-4378

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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