NCT03470636

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable atrial-fibrillation

Timeline
Completed

Started Feb 2018

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 15, 2018

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

March 6, 2018

Completed
14 days until next milestone

First Posted

Study publicly available on registry

March 20, 2018

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 15, 2018

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 16, 2020

Completed
Last Updated

February 8, 2021

Status Verified

February 1, 2021

Enrollment Period

9 months

First QC Date

March 6, 2018

Last Update Submit

February 5, 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:

  • paroxysmal atrial fibrillation 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

Related Publications (1)

  • Schmidt B, Petru J, Chun KRJ, Sediva L, Bordignon S, Chen S, Neuzil P. Pivotal Study of a Novel Motor-Driven Endoscopic Ablation System. Circ Arrhythm Electrophysiol. 2021 Mar;14(3):e009544. doi: 10.1161/CIRCEP.120.009544. Epub 2021 Feb 11.

    PMID: 33570423DERIVED

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

March 6, 2018

First Posted

March 20, 2018

Study Start

February 15, 2018

Primary Completion

November 15, 2018

Study Completion

January 16, 2020

Last Updated

February 8, 2021

Record last verified: 2021-02

Locations

CZ(1)