Low Fluoroscopy Afib Ablation Registry | NCT02830750

Studies
Low Fluoroscopy Afib Ablation Registry

NCT02830750

Sponsor

Stanford University

Status

Completed

Last Update Posted

Apr 26, 2018Actual

Enrollment

160Actual

Phase

Not provided

Conditions

Atrial Fibrillation

Interventions

Ablation

Countries

United States

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

Apr 2018

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

Apr 2016

Primary Completion Date

Apr 2018Actual

Completion Date

Apr 2018Actual

First Submitted Date

Jun 28, 2016

First Submission Date that Met QC Criteria

Jul 12, 2016

First Posted Date

Jul 13, 2016Estimated

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

Apr 24, 2018

Last Update Posted Date

Apr 26, 2018Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Gerri O'Riordan, Direcetor of Clinical Resarch. CV Med, Stanford UniversityPrincipal Investigator

Lead Sponsor

Stanford UniversityOTHER

Collaborators

Name	Class
Beacon Medical Group	UNKNOWN
Brigham and Women's Hospital	OTHER
Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

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

Prospective data collection of patients undergoing Atrial Fibrillation Ablation.

Detailed Description

Clinicians who have experience using low dose fluoroscopy including use of Carto Mapping system will consent patients to allow data collection and a 12 month f/up visit to track adverse events. Clinicians will follow a protocol which will be similar to their standard of care for ablations.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

1 Year

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

160Actual

Name	Type	Description	Arm Group Labels	Other Names
Ablation	Procedure

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Atrial Fibrillation	Determine Atrial Fibrillation burden at 12 month visit by reviewing monitoring systems that capture this data	12 months

Secondary Outcomes

Measure	Description	Time Frame
Fluoroscopic Usage	To determine total amount of radiation used at each procedure by estimation of mGy	post operative

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patient meets accepted AHA/ACC/HRS guideline indications for catheter ablation of paroxysmal or persistent AF
First or subsequent ablation procedures may be included
Age 18-75

Exclusion Criteria:

Known venous malformations or implanted instrumentation (IVC filter)
Known PV stenosis
Unable to provide consent
H/O mechanical mitral valve replacement (unable to rely on EA mapping only)
Documented left atrial thrombus
Prior ASD repair Pregnancy
NYHA >=3
EF less than 35%
CHF within 90 daysRecent MI or coronary revascularization within 90 days
NOTE: H/O implanted pacemaker or ICD with transvenous leads will NOT be an exclusion criteria, but we will track patients treated with pre-existing transvenous leads with the hypothesis that although fluoroscopy use will be higher in these patients compared to those without leads, but still lower than conventionally treated patients.
Patients who are undergoing non- standard of care ablations ie, Cyro or FIRM ablations

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

Patients who have persistant or paroxysmal atrial fibrillation

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Chad Brodt, MD PHD	Stanford University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Beacon Medical Group		South Bend	Indiana	46601	United States
Brigham's Women's Hospital

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