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Hybrid AF -- A Prospective Registry

This study is enrolling participants by invitation only.
Sponsor:
Collaborator:
Estech
Information provided by (Responsible Party):
Dhanunjaya Lakkireddy, MD, FACC, University of Kansas Medical Center Research Institute
ClinicalTrials.gov Identifier:
NCT01636518
First received: July 5, 2012
Last updated: January 22, 2013
Last verified: January 2013
History of Changes
  Purpose

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 Intervention
Atrial Fibrillation
 Procedure: Standard of Care

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Hybrid Procedure for the Treatment of Long Standing Persistent Atrial Fibrillation - A Prospective Registry

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Kansas:

Estimated Enrollment: 150
Study Start Date: July 2012
Estimated Primary Completion Date: July 2017 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01636518

Locations
United States, Kansas
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160
Sponsors and Collaborators
Dhanunjaya Lakkireddy, MD, FACC
Estech
Investigators
Principal Investigator: Dhanunjaya Lakkireddy, MD, FACC University of Kansas
  More Information

No publications provided

Responsible Party: Dhanunjaya Lakkireddy, MD, FACC, Associate Professor, University of Kansas Medical Center Research Institute
ClinicalTrials.gov Identifier: NCT01636518     History of Changes
Other Study ID Numbers: 13117
Study First Received: July 5, 2012
Last Updated: January 22, 2013
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on May 21, 2013