Clinical trial NCT01636518: Hybrid AF -- A Prospective Registry
Official title: Hybrid Procedure for the Treatment of Long Standing Persistent Atrial Fibrillation - A Prospective Registry
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Atrial Fibrillation
Lead sponsor: University of Kansas Medical Center
Sponsor class: OTHER
Collaborators: name: Estech
First posted: 2012-07-10
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing standard of care procedures to treat Atrial Fibrillation at the University of Kansas Hospital

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.


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

Primary outcomes:
measure: Outcomes of patients with persistent Atrial Fibrillation who undergo the standard of care hybrid procedure
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of Kansas Medical Center
name: Dhanunjaya Lakkireddy, MD, FACC
role: PRINCIPAL_INVESTIGATOR
References: