Trial Search Results

Dual Epicardial Endocardial Persistent Atrial Fibrillation(AF) Study (Staged DEEP)

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.

Stanford is currently accepting patients for this trial.

Lead Sponsor:

AtriCure, Inc.

Intervention(s):

  • Device: Ablation procedure staged catheter ablation

Phase:

N/A

Eligibility


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

Ages Eligible for Study

18 Years - N/A

Genders Eligible for Study

All

Now accepting new patients

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Linda Norton
650-725-5597
Recruiting