Dual Epicardial Endocardial Persistent Atrial Fibrillation(AF) Study (Staged DEEP)
United States, Belgium, Netherlands30 participantsStarted 2012-08
Plain-language summary
The purpose of this study is to assess the safety and technical feasibility of treating subjects with Persistent Atrial Fibrillation or Longstanding Persistent Atrial Fibrillation in a minimally invasive thoracoscopic ablation procedure utilizing the AtriCure Bipolar System, with mapping and additional lesion creation/ gap closure (as needed) provided by currently approved catheter technology, when the epicardial and endocardial phases are performed in a staged manner within 1-10 days apart, during the same hospitalization.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Age \> 18 year
* Patients with symptomatic persistent or longstanding persistent AF refractory to a minimum of one Class I or III antiarrhythmic drug (AAD).
* Patients with failed catheter ablation attempts are eligible if the patients are symptomatic with persistent or longstanding persistent AF. (catheter ablation procedure must be more than 3 months prior to index procedure)
* Life expectancy of at least two years
* Patient will and able to provide informed consent
* Patient is willing and able to attend the scheduled follow-up visits
Exclusion Criteria:
* Prior Cardiothoracic Surgery
* Patient has NYHA (New York Heart Association) Class IV heart failure
* Evidence of underlying structural heart disease requiring surgical treatment
* Surgical procedure within the 30 days prior to the index procedure
* 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of Patients With Pre-specified Safety Endpoints Occurring in the First 30 Days Post-index Procedure or Hospital Discharge, Whichever is Longer.
Timeframe: 30 days post-index procedure or hospital discharge
2
Number of Subjects With Absence of Atrial Fibrillation