Low Fluoroscopy Afib Ablation Registry

NCT ID: NCT02830750

Last Updated: 2018-04-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

160 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-04-30

Study Completion Date

2018-04-30

Brief Summary

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Prospective data collection of patients undergoing Atrial Fibrillation Ablation.

Detailed Description

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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.

Conditions

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Atrial Fibrillation

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Interventions

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Ablation

Intervention Type PROCEDURE

Eligibility Criteria

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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
* Patients who are undergoing non- standard of care ablations ie, Cyro or FIRM ablations
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Beacon Medical Group

UNKNOWN

Sponsor Role collaborator

Brigham and Women's Hospital

OTHER

Sponsor Role collaborator

Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)

OTHER

Sponsor Role collaborator

Stanford University

OTHER

Sponsor Role lead

Responsible Party

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Gerri O'Riordan

Direcetor of Clinical Resarch. CV Med

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Chad Brodt, MD PHD

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

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Beacon Medical Group

South Bend, Indiana, United States

Site Status

Brigham's Women's Hospital

Boston, Massachusetts, United States

Site Status

Countries

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United States

Other Identifiers

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35821

Identifier Type: -

Identifier Source: org_study_id

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