Hybrid AF -- A Prospective Registry

NCT01636518 | Withdrawn

• 1 other identifier: 13117
• Study Type: observational
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• Outcomes of patients with persistent Atrial Fibrillation who undergo the standard of care hybrid procedure

  2 years

Study Arms (1)

Atrial Fibrillation

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

Procedure: Standard of Care

Interventions

Standard of Care PROCEDURE

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

Atrial Fibrillation

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing standard of care procedures to treat Atrial Fibrillation at the University of Kansas Hospital

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Dhanunjaya Lakkireddy, MD, FACC: lead
• Estech: collaborator

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Dhanunjaya Lakkireddy, MD, FACC

  University of Kansas Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: July 5, 2012
• First Posted: July 10, 2012
• Study Start: July 1, 2012
• Primary Completion: January 1, 2015
• Study Completion: January 1, 2015
• Last Updated: April 22, 2015

Record last verified: 2015-04