Ultrasensitive Electroanatomic Mapping to Adjudicate Endp... | NCT04109053

Studies
Ultrasensitive Electroanatomic Mapping to Adjudicate Endpoints for Ablation In Paroxysmal AF Patients Using Cryoballoon

NCT04109053

Sponsor

BayCare Health System

Status

Withdrawn

Last Update Posted

Oct 1, 2025Actual

Enrollment

0Actual

Phase

Not provided

Conditions

Paroxysmal Atrial Fibrillation

Interventions

Not provided

Countries

Not provided

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

Sep 2025

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

PI did not move forward with study

Expanded Access Info

Start Date

Mar 2, 2020Estimated

Primary Completion Date

Mar 31, 2021Estimated

Completion Date

Apr 30, 2021Estimated

First Submitted Date

Sep 27, 2019

First Submission Date that Met QC Criteria

Sep 27, 2019

First Posted Date

Sep 30, 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

Sep 25, 2025

Last Update Posted Date

Oct 1, 2025Actual

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

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Ultrasensitive Electroanatomic Mapping to Adjudicate Endpoints for Ablation In Paroxysmal AF Patients Using Cryoballoon

Detailed Description

Collected data include procedural parameters relevant to pulmonary vein isolation as outlined in the protocol section, DE identified patient demographics, follow up information including rhythm status, antiarrhythmic medication usage, and symptoms or signs to suggest procedural complications relevant to the pulmonary vein isolation procedure.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Frequency of acute pulmonary vein isolation as adjudicated by pacing catheter based entrance/exit block, and Orion derived activation and voltage map.		12 months

Secondary Outcomes

Measure	Description	Time Frame
AT/AF free survival		12 months
Procedural endpoints including total procedure time, LA dwell time, total flouro time, total ablation time, and total mapping time.		12 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients undergoing pulmonary vein isolation using cryoballoon at St. Joseph's Hospital in FL that sign informed consent

Exclusion Criteria:

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Patients undergoing pulmonary vein isolation using cryoballoon at St. Joseph's Hospital in FL that sign informed consent

Sampling Method

Probability Sample

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

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