ABLATE Post Approval Study - Synergy Ablation Lesions for Non-Paroxysmal AF
Status: | Completed |
---|---|
Conditions: | Atrial Fibrillation |
Therapuetic Areas: | Cardiology / Vascular Diseases |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 4/17/2018 |
Start Date: | September 2012 |
End Date: | March 21, 2018 |
AtriCure Synergy Ablation Lesions for Non-Paroxysmal Forms of Atrial Fibrillation Treatment During Concomitant On-Pump Endo/Epicardial Cardiac Surgery
The primary objective of this post-approval study is to evaluate the clinical outcomes in a
cohort of patients with non-paroxysmal forms of atrial fibrillation (persistent or
long-standing persistent) treated during commercial use of the AtriCure Synergy Ablation
System by physicians performed the Maze IV procedure.
cohort of patients with non-paroxysmal forms of atrial fibrillation (persistent or
long-standing persistent) treated during commercial use of the AtriCure Synergy Ablation
System by physicians performed the Maze IV procedure.
This prospective, open label, multi-center, observational, single arm registry is designed to
monitor the AtriCure Synergy Ablation System continued safety and efficacy during the
peri-procedural and long-term phase during commercial use in patients being treated for
non-paroxysmal forms of atrial fibrillation who are undergoing a concomitant open, on-pump
cardiac surgical procedure.
monitor the AtriCure Synergy Ablation System continued safety and efficacy during the
peri-procedural and long-term phase during commercial use in patients being treated for
non-paroxysmal forms of atrial fibrillation who are undergoing a concomitant open, on-pump
cardiac surgical procedure.
Inclusion Criteria:
- Age > or equal to 18 years of age
- History of non-paroxysmal form of AF as defined by the HRS/EHRA/ECAS Consensus
Statement:
- Persistent AF shall be defined as continuous AF that is sustained beyond seven
days. Episodes of AF in which a decision is made to electrically or
pharmacologically cardiovert the patient after greater than or equal to 48 hours
of AF but prior to 7 days, should also be classified as persistent AF episodes.
- Longstanding persistent AF shall be defined as continuous AF of greater than 12
months duration. The performance of a successful cardioversion (sinus rhythm >30
seconds) within 12 months of an ablation procedure with documented early
recurrence of AF with 30 days should not alter the classification of AF as
longstanding persistent.
- Subject is scheduled to undergo elective open cardiac surgical procedure(s) to be
performed on cardiopulmonary bypass for one or more of the following: Coronary Artery
Bypass Grafting, Mitral valve repair or replacement, Aortic valve repair or
replacement, Tricuspid valve repair or replacement. In conjunction with these
procedure patent foramen ovale (PFO) or atrial septal defect (ASD) repair are allowed.
- The patient (or their legally authorized representative) agrees to participate in this
study by singing the IRB approved informed consent form.
- Willing and able to return for scheduled follow up visits.
Exclusion Criteria:
- Stand along AF without indication(s) for concomitant cardiac surgery.
- Need for emergent cardiac surgery (i.e., cardiogenic shock).
- Preoperative need for an intra-aortic balloon pump or intravenous inotropes.
- Pregnancy or desire to get pregnant for the duration of the study concomitant surgical
procedure through the thirty six (36) month follow up period).
- Enrolled in another clinical trial that could confound th e results of this study.
We found this trial at
49
sites
3181 Southwest Sam Jackson Park Road
Portland, Oregon 97239
Portland, Oregon 97239
503 494-8311
Oregon Health and Science University In 1887, the inaugural class of the University of Oregon...
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University of Alabama at Birmingham The University of Alabama at Birmingham (UAB) traces its roots...
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The Hartford Hospital Hartford Hospital is the major teaching hospital affiliated with the University of...
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Sentara Norfolk General Hospital Sentara Norfolk General Hospital is recognized as the number one ranked...
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Allegheny General Hospital At Allegheny General Hospital, our physicians and healthcare staff have earned an...
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Virginia Commonwealth University Since our founding as a medical school in 1838, Virginia Commonwealth University...
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Missouri Baptist Medical Center You just feel it. The smile that greets you. The hand...
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Sharp Memorial Hospital Sharp Memorial Hospital offers clinical excellence with the latest technology and patient-centered...
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Swedish Medical Center Since 1910, Swedish has been the region's hallmark for excellence in health...
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Toledo Hospital ProMedica’s Mission is to improve your health and well-being. And we at ProMedica...
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Munson Medical Center There’s no place quite like northern Michigan, and there is no other...
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