NCT02830750

Brief Summary

Prospective data collection of patients undergoing Atrial Fibrillation Ablation.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
160

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2016

Geographic Reach
1 country

2 active sites

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

April 1, 2016

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

June 28, 2016

Completed
15 days until next milestone

First Posted

Study publicly available on registry

July 13, 2016

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2018

Completed
Last Updated

April 26, 2018

Status Verified

April 1, 2018

Enrollment Period

2 years

First QC Date

June 28, 2016

Last Update Submit

April 24, 2018

Conditions

Atrial Fibrillation

Outcome Measures

Primary Outcomes (1)

  • Atrial Fibrillation

    Determine Atrial Fibrillation burden at 12 month visit by reviewing monitoring systems that capture this data

    12 months

Secondary Outcomes (1)

  • Fluoroscopic Usage

    post operative

Interventions

AblationPROCEDURE

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients who have persistant or paroxysmal atrial fibrillation

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Beacon Medical Group

South Bend, Indiana, 46601, United States

Location

Brigham's Women's Hospital

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Chad Brodt, MD PHD

    Stanford University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Target Duration
1 Year
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Direcetor of Clinical Resarch. CV Med

Study Record Dates

First Submitted

June 28, 2016

First Posted

July 13, 2016

Study Start

April 1, 2016

Primary Completion

April 1, 2018

Study Completion

April 1, 2018

Last Updated

April 26, 2018

Record last verified: 2018-04

Data Sharing

IPD Sharing
Will not share

Locations

US(2)