NCT03988244

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
11

participants targeted

Target at below P25 for not_applicable atrial-fibrillation

Timeline
Completed

Started Feb 2019

Shorter than P25 for not_applicable atrial-fibrillation

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 26, 2019

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2019

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

June 13, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 17, 2019

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 3, 2020

Completed
Last Updated

July 20, 2021

Status Verified

July 1, 2021

Enrollment Period

2 months

First QC Date

June 13, 2019

Last Update Submit

July 19, 2021

Conditions

Atrial Fibrillation

Outcome Measures

Primary Outcomes (1)

  • Ablation time

    Ablation time

    Acute - at the end of the index procedure

Secondary Outcomes (4)

  • Procedure time

    Acute - at the end of the index procedure

  • PV Isolation

    Acute - at the end of the index procedure

  • PAE Rate

    30 Days

  • AF Free Rate

    6 and 12 months

Study Arms (1)

HeartLight X3

EXPERIMENTAL

Pulmonary vein isolation using HeartLight X3

Device: HeartLight X3

Interventions

HeartLight X3DEVICE

Pulmonary vein isolation

HeartLight X3

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • overall good health as established by multiple criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nemocnice Na Homolce

Prague, Czechia

Location

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Burke T. Barrett

    CardioFocus, Inc.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 13, 2019

First Posted

June 17, 2019

Study Start

February 26, 2019

Primary Completion

April 30, 2019

Study Completion

April 3, 2020

Last Updated

July 20, 2021

Record last verified: 2021-07

Locations

CZ(1)