Hybrid AF -- A Prospective Registry

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01636518
Recruitment Status : Withdrawn
First Posted : July 10, 2012
Last Update Posted : April 22, 2015
Information provided by (Responsible Party):
Dhanunjaya Lakkireddy, MD, FACC, University of Kansas Medical Center

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.

Condition or disease Intervention/treatment
Atrial Fibrillation Procedure: Standard of Care

Study Type : Observational
Actual Enrollment : 0 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Hybrid Procedure for the Treatment of Long Standing Persistent Atrial Fibrillation - A Prospective Registry
Study Start Date : July 2012
Actual Primary Completion Date : January 2015
Actual Study Completion Date : January 2015

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort Intervention/treatment
Atrial Fibrillation
Patients with Atrial Fibrillation that undergo standard of care procedure at the University of Kansas Hospital
Procedure: Standard of Care
Standard of care procedure as determined by treating physician for Atrial Fibrillation

Primary Outcome Measures :
  1. Outcomes of patients with persistent Atrial Fibrillation who undergo the standard of care hybrid procedure [ Time Frame: 2 years ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients undergoing standard of care procedures to treat Atrial Fibrillation at the University of Kansas Hospital

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01636518

Sponsors and Collaborators
Dhanunjaya Lakkireddy, MD, FACC
Principal Investigator: Dhanunjaya Lakkireddy, MD, FACC University of Kansas Medical Center

Responsible Party: Dhanunjaya Lakkireddy, MD, FACC, Associate Professor, University of Kansas Medical Center Identifier: NCT01636518     History of Changes
Other Study ID Numbers: 13117
First Posted: July 10, 2012    Key Record Dates
Last Update Posted: April 22, 2015
Last Verified: April 2015

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes