Hybrid AF -- A Prospective Registry
| Status: | Not yet recruiting |
|---|---|
| Conditions: | Atrial Fibrillation |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 11/18/2012 |
| Start Date: | July 2012 |
| Contact: | Donita Atkins, RN |
| Email: | datkins@mac.md |
| Phone: | (913) 588-9714 |
Hybrid Procedure for the Treatment of Long Standing Persistent Atrial Fibrillation - A Prospective Registry
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.
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
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