CONcomitant eValuation of Epicor Left atRial Therapy for AF
NCT ID: NCT00519194
Last Updated: 2019-02-19
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
TERMINATED
NA
112 participants
INTERVENTIONAL
2009-04-30
2013-03-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Treatment of Persistent Atrial Fibrillation With Sphere-9 Catheter and Affera Mapping and Ablation System
NCT05120193
Evaluation of the Cardioblate CryoFlex Surgical Ablation System in Longstanding Persistent Atrial Fibrillation
NCT01558635
Clinical and Economic Consequences of Left Atrial Bipolar Radiofrequency Ablation of Persistent and Permanent Atrial Fibrillation During Cardiac Surgery
NCT00157807
Comparison of Treatment of Atrial Fibrillation (AF) Between Surgical Ultrasonic Technology or Drug Therapy for Patients With AF Requiring Mitral Valve Surgery
NCT01649544
Atrial Fibrillation Ablation and Autonomic Modulation Via Thorascopic Surgery
NCT01091389
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Epicor Cardiac Ablation
Epicor LP Cardiac Ablation System
Surgical ablation of permanent AF during concomitant open chest and/or open heart surgery
Surgical ablation of permanent AF
Concomitant AF ablation during mitral valve surgery
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Epicor LP Cardiac Ablation System
Surgical ablation of permanent AF during concomitant open chest and/or open heart surgery
Surgical ablation of permanent AF
Concomitant AF ablation during mitral valve surgery
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Permanent AF defined as continuous AF lasting \> one year OR non self-terminating AF lasting \> seven days but no more than one year with at least one failed DC cardioversion
* Have a concomitant indication for open chest and/or open heart surgery for one or more of the following: mitral valve repair or replacement, aortic valve repair or replacement, tricuspid valve repair or replacement, patent foramen ovale (PFO) closure or coronary artery bypass surgery
* Be able to take anticoagulation therapy
* Be able to fulfill study requirements
* Be able to sign study-specific informed consent
Exclusion Criteria
* Prior cardiac surgery
* Presence of active endocarditis, local or system infection
* Presence of advanced heart failure (NYHA class \> II, \& LVEF \< 20%)
* Intraaortic balloon pump, IV inotropes or vasoactive agents within 30 days
* Emergent cardiac surgery due to acute MI or acute mitral regurgitation
* Life expectancy \< 1 year
* Major or progressive non-cardiac disease
* Presence of left atrial thrombi
* Left atrial diameter \> 6.0 cm
* Any condition that prevents investigator from safely performing procedure
* Positive urine or serum pregnancy test
* Prior left atrial ablation
* Currently participating in another clinical research study
18 Years
80 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Abbott Medical Devices
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Mark Groh, MD
Role: PRINCIPAL_INVESTIGATOR
Mission Hospitals
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
St. Agnes Medical Center
Fresno, California, United States
Manatee Memorial Hospital
Bradenton, Florida, United States
Blake Medical Center
Bradenton, Florida, United States
Cardiology Consultants, MD's PA (Baptist Hospital)
Pensacola, Florida, United States
NorthShore University Health System
Evanston, Illinois, United States
Community Hospital
Munster, Indiana, United States
Midatlanatic Cardiovascular Associates, PA; Union Memorial Hospital
Baltimore, Maryland, United States
William Beaumont Hospital
Royal Oak, Michigan, United States
Minneapolis Heart Institute Foundation/Abbott NW Hospital
Minneapolis, Minnesota, United States
HealthEast St. Joseph's Hospital
Saint Paul, Minnesota, United States
Hackensack University Medical Center
Hackensack, New Jersey, United States
University of Rochester Medical Center
Rochester, New York, United States
St. Francis Hospital
Roslyn, New York, United States
Mission Hospital, Inc
Asheville, North Carolina, United States
Duke University Medical Center
Durham, North Carolina, United States
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
051.13
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.