Low Fluoroscopy Afib Ablation Registry

Atrial Fibrillation Clinical Trial

Official title:

A Multi Center Registry of Low- Fluoroscopy Atrial Fibrillation Ablation Using Electroanatomic Mapping Carto

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02830750
• Other study ID #: 35821
• Status: Completed
• First received: June 28, 2016
• Last updated: April 24, 2018
• Start date: April 2016
• Est. completion date: April 2018

Study information

• Verified date: April 2018
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

Prospective data collection of patients undergoing Atrial Fibrillation Ablation.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 160
• Est. completion date: April 2018
• Est. primary completion date: April 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Procedure:
• Ablation

Locations

Country	Name	City	State
United States	Brigham's Women's Hospital	Boston	Massachusetts
United States	Beacon Medical Group	South Bend	Indiana

Sponsors (4)

Lead Sponsor	Collaborator
Stanford University	Allegheny Singer Research Institute, Beacon Medical Group, Brigham and Women's Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Atrial Fibrillation	Determine Atrial Fibrillation burden at 12 month visit by reviewing monitoring systems that capture this data	12 months
Secondary	Fluoroscopic Usage	To determine total amount of radiation used at each procedure by estimation of mGy	post operative