Hybrid AF -- A Prospective Registry

NCT ID: NCT01636518

Last Updated: 2015-04-22

Basic Information

• Recruitment Status: WITHDRAWN
• Study Classification: OBSERVATIONAL
• Study Start Date: 2012-07-31
• Study Completion Date: 2015-01-31

Brief 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.

Conditions

Atrial Fibrillation

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Atrial Fibrillation

Patients with Atrial Fibrillation that undergo standard of care procedure at the University of Kansas Hospital

Standard of Care

Intervention Type: PROCEDURE

Standard of care procedure as determined by treating physician for Atrial Fibrillation

Interventions

Standard of Care

Standard of care procedure as determined by treating physician for Atrial Fibrillation

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Estech

OTHER

Sponsor Role: collaborator

Dhanunjaya Lakkireddy, MD, FACC

OTHER

Sponsor Role: lead

Responsible Party

Dhanunjaya Lakkireddy, MD, FACC

Associate Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Dhanunjaya Lakkireddy, MD, FACC

Role: PRINCIPAL_INVESTIGATOR

University of Kansas Medical Center

Other Identifiers

13117

Identifier Type: -

Identifier Source: org_study_id