HeartLight X3 Endoscopic Ablation System With Excalibur B... | NCT03988244

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

NCT03988244

Sponsor

CardioFocus

Status

Completed

Last Update Posted

Jul 20, 2021Actual

Enrollment

11Actual

Phase

Not Applicable

Conditions

Atrial Fibrillation

Interventions

HeartLight X3

Countries

Czechia

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 26, 2019Actual

Primary Completion Date

Apr 30, 2019Actual

Completion Date

Apr 3, 2020Actual

First Submitted Date

Jun 13, 2019

First Submission Date that Met QC Criteria

Jun 13, 2019

First Posted Date

Jun 17, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 19, 2021

Last Update Posted Date

Jul 20, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

11Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
HeartLight X3	Experimental	Pulmonary vein isolation using HeartLight X3	Device: HeartLight X3

Interventions

Name	Type	Description	Arm Group Labels	Other Names
HeartLight X3	Device	Pulmonary vein isolation	HeartLight X3

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
Procedure time	Procedure time	Acute - at the end of the index procedure
PV Isolation	Percent of isolated pulmonary veins	Acute - at the end of the index procedure

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

overall good health as established by multiple criteria

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Burke T. Barrett	CardioFocus, Inc.	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Nemocnice Na Homolce		Prague			Czechia

Condition Browse Module

MeSH Terms

ID	Term
D001281	Atrial Fibrillation

Ancestor Terms

ID	Term
D001145	Arrhythmias, Cardiac
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D010335	Pathologic Processes

Browse Leaves

Not provided

Browse Branches

Not provided