Dual Epicardial Endocardial Persistent Atrial Fibrillation (AF) Study - Full Text View

Sponsor:	AtriCure, Inc.
Information provided by (Responsible Party):	AtriCure, Inc.
ClinicalTrials.gov Identifier:	NCT01246466

Purpose

The purpose of this clinical investigation is to evaluate how safe a less invasive cardiac surgery is using the AtriCure Bipolar System combined with a catheter ablation procedure in treating AF, and how effective this combined procedure is using the AtriCure System in treating AF. The AtriCure Bipolar System will be used to perform the less invasive cardiac surgery and a standard electrophysiology catheter, currently available, will be used to perform the catheter ablation procedure. This surgical procedure is considered less invasive because it is done through tiny surgical punctures on the sides of the chest near the ribs instead of one large surgical incision of the breast bone to completely open the chest and access the heart, and it also avoids the need for the heart-lung bypass machine.

Condition	Intervention	Phase
Persistent Atrial Fibrillation or Longstanding Persistent Atrial Fibrillation	Device: Hybrid ablation procedure	Phase 1 Phase 2

Study Type:	Interventional
Study Design:	Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Feasibility Trial of a Hybrid Approach for Treatment of Patients With Persistent or Longstanding Persistent Atrial Fibrillation With Radiofrequency Ablation

Resource links provided by NLM:

Genetics Home Reference related topics: Brugada syndrome familial atrial fibrillation short QT syndrome

MedlinePlus related topics: Atrial Fibrillation

U.S. FDA Resources

Further study details as provided by AtriCure, Inc.:

Primary Outcome Measures:

composite of pre-specified safety endpoints occurring in the first 30 days post-index procedure or hospital discharge, whichever is longer. [ Time Frame: Within the first 30 days post-index procedure or hospital discharge ] [ Designated as safety issue: Yes ]
Absence of atrial fibrillation [ Time Frame: 12 month follow-up ] [ Designated as safety issue: No ]
Absence of atrial fibrillation (AF) at twelve month follow-up based on an auto trigger event monitor, while off all Class I and III antiarrhythmic therapy.

Secondary Outcome Measures:

Overall Serious Device or Procedure Related Adverse Event Rate [ Time Frame: 12 month follow-up ] [ Designated as safety issue: Yes ]
Acute Procedure Success [ Time Frame: Upon completion of the index procedure ] [ Designated as safety issue: No ]
Absence of atrial fibrillation [ Time Frame: 12 month ] [ Designated as safety issue: No ]
Absence of atrial fibrillation after the 3 month blanking period through twelve month follow-up based on auto trigger event monitor.
Incidence of Reintervention [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Incidence of DC cardioversion [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Improvement in AF [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Improvement in AF Symptom Checklist Frequency and Severity Scores.
Duration of procedure [ Time Frame: index procedure ] [ Designated as safety issue: No ]

Estimated Enrollment:	30
Study Start Date:	November 2010
Estimated Study Completion Date:	April 2013
Estimated Primary Completion Date:	April 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: AtriCure Bipolar System combined with a catheter ablation procedure using the AtriCure Bipolar System plus a catheter ablation	Device: Hybrid ablation procedure AtriCure Bipolar System plus a catheter ablation

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Age > 18 years
Patients with symptomatic (e.g. palpitations, shortness of breath, fatigue) persistent or longstanding persistent AF Persistent
Patient is willing and able to provide written informed consent.
Patient has a life expectancy of at least 2 years.
Patient is willing and able to attend the scheduled follow-up visits.

Exclusion Criteria:

Prior Cardiothoracic Surgery.
Patient has NYHA Class IV heart failure.
Evidence of underlying structural heart disease requiring surgical treatment.
Ejection fraction < 30%
Measured left atrial diameter > 6.0 cm
Renal Failure
Stroke within previous 6 months.
Known carotid artery stenosis greater than 80%.
Evidence of significant active infection or endocarditis.
Pregnant woman or women desiring to become pregnant in the next 24 months.
Presence of thrombus in the left atrium determined by echocardiography.
History of blood dyscrasia.
Contraindication to anticoagulation, based on Investigator's opinion.
Mural thrombus or tumor.
Moderate to Severe COPD

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01246466

Locations

United States, California
Stanford University Medical Center
Stanford, California, United States, 94305
United States, Tennessee
Vanderbilt Heart Institute
Nashville, Tennessee, United States, 37232
United States, Texas
Texas Cardiac Arrhythmia
Austin, Texas, United States, 78705
Baylor Health
Plano, Texas, United States, 75093
United States, Virginia
UVA
Charlottesville, Virginia, United States, 22908
Sentara Norfolk
Norfolk, Virginia, United States, 23507

Sponsors and Collaborators

AtriCure, Inc.

More Information

No publications provided

Responsible Party:	AtriCure, Inc.
ClinicalTrials.gov Identifier:	NCT01246466 History of Changes
Other Study ID Numbers:	CP2009-1
Study First Received:	November 22, 2010
Last Updated:	December 13, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by AtriCure, Inc.:

Persistent Atrial Fibrillation, Longstanding Persistent Atrial Fibrillation, Ablation, catheter ablation

Additional relevant MeSH terms:

Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on May 23, 2012