- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00785902
AtriCure Bipolar Radiofrequency Ablation of Persistent Atrial Fibrillation (A)
February 18, 2011 updated by: AtriCure, Inc.
ABLATE Persistent is a prospective, non-randomized multi-center clinical trial to demonstrate the safety and effectiveness of the AtriCure Bipolar System for treating persistent atrial fibrillation during concomitant on-pump cardiac surgery.
Study Overview
Status
Withdrawn
Conditions
Intervention / Treatment
Study Type
Interventional
Phase
- Phase 3
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Subject is greater than or equal to 18 years of age
- Subject has history of persistent atrial fibrillation as defined by the ACC/AHA/ESC Guidelines
Subject is scheduled to undergo elective on-pump cardiac surgical procedure(s) for one or more of the following:
- Mitral valve repair or replacement
- Aortic valve repair or replacement
- Tricuspid valve repair or replacement
- Coronary Artery Bypass procedures
- Subject's Left Ventricular Ejection Fraction ≥ 30%
- Subject is able and willing to provide written informed consent and comply with study requirements
- Subject has life expectancy of at least 1 year
Exclusion Criteria:
- Patients with longstanding and continuous AF in which cardioversion has failed or has not been attempted
- Previous cardiac ablation including catheter ablation, AV-nodal ablation, or surgical Maze procedure
- Wolff-Parkinson-White syndrome
- Prior cardiac surgery (Redo)
- Class IV NYHA heart failure symptoms
- Prior history of cerebrovascular accidents within 6 months or at any time if there is residual neurological deficit
- Documented MI within 6 weeks prior to study enrollment
- Need for emergent cardiac surgery (i.e. cardiogenic shock)
- Known carotid artery stenosis greater than 80%
- LA size greater than or equal to 8 cm
- Current diagnosis of active systemic infection
- Severe peripheral arterial occlusive disease defined as claudication with minimal exertion
- Pregnancy or desire to get pregnant within 12-months of the study enrollment
- Preoperative need for an intra-aortic balloon pump or intravenous inotropes
- Renal failure requiring dialysis or hepatic failure
- Requires anti-arrhythmic drug therapy for the treatment of a ventricular arrhythmia
- Therapy resulting in compromised tissue integrity including: thoracic radiation, chemotherapy, long term treatment with oral or injected steroids, or known connective tissue disorders
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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The primary efficacy endpoint for this study is the percent of patients free from AF and off Class I and III antiarrhythmic drugs at 9 months.
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The primary safety endpoint is the composite acute major adverse event rate, within 30 days post-procedure or hospital discharge
|
Secondary Outcome Measures
Outcome Measure |
---|
The secondary efficacy endpoint for this study is the percent of patients free from AF, independent of antiarrhythmic drug status at 9 months
|
The secondary safety endpoint is the composite 9-month post-procedure major adverse event rate.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Registration Dates
First Submitted
November 3, 2008
First Submitted That Met QC Criteria
November 3, 2008
First Posted (ESTIMATE)
November 5, 2008
Study Record Updates
Last Update Posted (ESTIMATE)
February 21, 2011
Last Update Submitted That Met QC Criteria
February 18, 2011
Last Verified
February 1, 2011
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CP2008-1
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Atrial Fibrillation
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Ablacon, Inc.CompletedArrhythmias, Cardiac | Atrial Fibrillation, Persistent | Persistent Atrial Fibrillation | Longstanding Persistent Atrial FibrillationGermany
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Ablacon, Inc.RecruitingAtrial Fibrillation | Arrhythmias, Cardiac | Arrhythmia | Atrial Flutter | Atrial Fibrillation, Persistent | Atrial Tachycardia | Atrial Arrhythmia | Atrial Fibrillation Paroxysmal | Atrial Fibrillation, Paroxysmal or PersistentUnited States, Belgium, Netherlands, Czechia
-
Barts & The London NHS TrustAtriCure, Inc.Not yet recruitingAtrial Fibrillation, Persistent | Persistent Atrial Fibrillation | Atrial Arrhythmia | Atrium; FibrillationUnited Kingdom
-
AtriCure, Inc.Active, not recruitingPersistent Atrial Fibrillation | Atrial Fibrillation (AF) | Longstanding Persistent Atrial FibrillationUnited States
-
Maastricht University Medical CenterRWTH Aachen UniversityUnknownAtrial Fibrillation (Paroxysmal) | Atrial Fibrillation Recurrent | Atrial Fibrillation Common Gene VariantsNetherlands
-
Adagio MedicalRecruitingAtrial Fibrillation | Atrial Flutter | Paroxysmal Atrial Fibrillation | Persistent Atrial FibrillationNetherlands, Germany, Belgium
-
Vivek ReddyEnrolling by invitationAtrial Fibrillation and Flutter | Atrial Flutter Typical | Atrial Fibrillation, Paroxysmal or PersistentUnited States
-
Fundació Institut de Recerca de l'Hospital de la...RecruitingAtrial Arrhythmia | Atrial Fibrillation and Flutter | Atrial Fibrillation RecurrentSpain
-
St. George's Hospital, LondonRecruitingAtrial Fibrillation | Atrial Fibrillation, Persistent | Persistent Atrial Fibrillation | Atrial ArrhythmiaUnited Kingdom
-
R-PharmFSBI "National Medical Research Center of Cardiology named after academician...CompletedAtrial Flutter | Paroxysmal Atrial Fibrillation | Persistent Atrial FibrillationRussian Federation
Clinical Trials on AtriCure Bipolar System
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AtriCure, Inc.Withdrawn
-
AtriCure, Inc.CompletedAtrial FibrillationUnited States
-
AtriCure, Inc.CompletedAtrial FibrillationUnited States
-
AtriCure, Inc.Unknown
-
AtriCure, Inc.CompletedPersistent Atrial Fibrillation | Longstanding Persistent Atrial FibrillationUnited States
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Norwegian University of Science and TechnologyUllevaal University Hospital; Oslo University Hospital; St. Olavs Hospital; Haukeland... and other collaboratorsWithdrawn
-
AtriCure, Inc.Active, not recruitingAtrial Fibrillation | Persistent or Longstanding Persistent Atrial FibrillationUnited States, Netherlands, Belgium
-
AtriCure, Inc.Cardialysis BVActive, not recruitingAtrial Fibrillation | Persistent and Longstanding Persistent Atrial FibrillationGermany, United Kingdom, Netherlands, Czechia, Poland
-
AtriCure, Inc.Enrolling by invitationAtrial Fibrillation
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University Hospital, ToulouseCompletedAtrial Fibrillation (AF)France