Dual Epicardial Endocardial Persistent Atrial Fibrillation(AF) Study (Staged DEEP)
- Conditions
- Atrial Fibrillation
- Interventions
- Device: Ablation procedure staged catheter ablation
- Registration Number
- NCT01661205
- Lead Sponsor
- AtriCure, Inc.
- Brief 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.
- Detailed Description
The purpose of this clinical investigation is to evaluate how safe a less invasive cardiac surgery using the AtriCure Bipolar System in conjunction with a catheter ablation procedure performed approximately 1-10 days after, in treating atrial fibrillation, and how effective is this staged procedure. The AtriCure Bipolar System will be used to perform the less invasive cardiac surgery and a standard electrophysiology catheter, currently available, will be used to perform the catheter ablation procedure. This surgical procedure is considered less invasive because it is done through tiny surgical punctures on the sides of the chest near the ribs instead of one large surgical incision of the breast bone to completely open the chest and access the heart, and it also avoids the need for the heart-lung bypass machine.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 30
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description AtriCure Bipolar System combined with a catheter ablation Ablation procedure staged catheter ablation Minimally invasive procedure using the AtriCure Bipolar System plus a catheter ablation performed approximately 1-10 days apart
- Primary Outcome Measures
Name Time Method Number of Subjects With Absence of Atrial Fibrillation 12 month follow-up Absence of atrial fibrillation (AF) at twelve month follow-up based on continuous 14 day ECG monitoring, while off all Class I and III antiarrhythmic therapy.
Number of Patients With Pre-specified Safety Endpoints Occurring in the First 30 Days Post-index Procedure or Hospital Discharge, Whichever is Longer. 30 days post-index procedure or hospital discharge Pre-specified events include: Death; Myocardial Infarction; Stroke or TIA; Excess bleeding; Pulmonary vein stenosis; atrio-esophagael fistula; phrenic nerve paralysis; Pericardial effusion; Embolisms.
- Secondary Outcome Measures
Name Time Method Number Subjects With Serious Device or Procedure Related Adverse Event Rate 12 month follow-up Number of Subjects With Direct Current (DC) Cardioversion 12 month follow-up Number of Subjects With Reinterventions 12 month follow-up Change in AF Based on AF Symptoms Checklist Frequency and Severity Scores 12 month follow-up Change in Atrial Fibrillation Symptom Checklist Frequency and Severity Scores. This is reported as change from Baseline.
1. This scale has 16 items to assess frequency of occurrence on a scale: Never; Rarely; Sometimes; Often; Always. These rating correspond to numerical values of: 1, 2, 3, 4, and 5, respectively. AF Frequency range from 0 to 80 . Higher scores indicating greater symptomatology.
2. The same items are also used to assess severity on a scale: Mild; Moderate; Severe. Corresponding to 1, 2, and 3, respectively. AF Severity score range from 0 to 48. Higher scores indicating greater symptomatology.
3. Negative change from baseline compared to 12-months represents an improvement in AF symptomatology .Number of Subjects With Acute Procedure Success Day 0 Defined as subject meeting all of the following criteria upon completion of the index-EP procedure
1. Isolation/block of all pulmonary veins (e.g. 4 of 4 veins);
2. Bi-directional cavotricuspid isthmus block;
3. Isolation of Box (i.e. no capture outside ablation lines connecting roof and floor lines between right-and-left pulmonary vein isolation lines);
4. Superior Vena Cava (SVC) isolation, if encircling SVC lesion performed.Number of Subject Without Atrial Fibrillation 6 and 12 month follow-up AF free with or without the need of antiarrhythmic drugs
Trial Locations
- Locations (6)
Universitair Ziekenhuis Brussel
🇧🇪Brussel, Belgium
Academic Medical Center
🇳🇱Amsterdam, Netherlands
Stanford University Medical Center
🇺🇸Stanford, California, United States
Colorado Springs Cardiology/Colorado Cardiac Alliance
🇺🇸Colorado Springs, Colorado, United States
Sentara Norfolk Hospital
🇺🇸Norfolk, Virginia, United States
Vanderbilt Heart Institute
🇺🇸Nashville, Tennessee, United States