Hybrid AF -- A Prospective Registry

Atrial Fibrillation Clinical Trial

Official title:

Hybrid Procedure for the Treatment of Long Standing Persistent Atrial Fibrillation - A Prospective Registry

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01636518
• Other study ID #: 13117
• Status: Withdrawn
• Phase: N/A
• First received: July 5, 2012
• Last updated: April 20, 2015
• Start date: July 2012
• Est. completion date: January 2015

Study information

• Verified date: April 2015
• Source: University of Kansas Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

Atrial Fibrillation (AF) is a form of rapid irregular heart rhythm that starts in the upper chambers of the heart (called atria) and is often associated with many health problems. It can cause stroke, palpitations and heart failure. The management of long standing (chronic) AF may require additional medications and blood thinners, potentially for life. It may also require procedures where the heart is shocked with an electrical current to restore normal rhythm. Some patients require a procedure called radiofrequency ablation to address the arrhythmia.

The purpose of this registry is to collect information on patients undergoing this combination of procedures into a database, and to then use this information for scientific study to improve the treatment of atrial fibrillation.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: January 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Documented effectiveness failure of at least one Vaughan-Williams Class III AAD

• Persistent AF as defined by the HRS/EHRA/ECAS Expert Consensus Statement on Catheter and Surgical Ablation of Atrial Fibrillation

• Absence of significant structural heart disease as demonstrated by a transthoracic echocardiogram (TTE) of all four chambers of the heart, computed tomography (CT) scan or magnetic resonance imaging (MRI) scan within 6 months prior to enrollment

• Absence of left atrial thrombus as documented by an imaging study (e.g., TTE, transesophageal echocardiogram (TEE), thoracic CT scan, MRI, or left atrial angiography) within 30 days prior to procedure

Exclusion Criteria:

• History of longstanding persistent AF for more than 3 years

• Documented left atrial size of 60 mm or more

• Documented left ventricular ejection fraction (LVEF) less than 40%

• History of cerebrovascular disease, including stroke or transient ischemic attack (TIA) within 6 months prior to enrollment

• Significant underlying structural heart disease requiring surgical or procedural intervention within the last six months of initial procedure

• Known contraindication to anticoagulant therapy, or inability to comply with anticoagulant therapy

• Other clinical conditions precluding inclusion (e.g., organ disease, disturbances of hemostasis, etc.)

• Pregnancy, planned pregnancy (females of childbearing potential must have a negative pregnancy test prior to enrollment and agree not to become pregnant during the trial) or breastfeeding;

• Concomitant procedure planned

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Procedure:
• Standard of Care
Standard of care procedure as determined by treating physician for Atrial Fibrillation

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Dhanunjaya Lakkireddy, MD, FACC	Estech

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Outcomes of patients with persistent Atrial Fibrillation who undergo the standard of care hybrid procedure		2 years	No