Dual Epicardial Endocardial Persistent Atrial Fibrillation(AF) Study (Staged DEEP) (Staged DEEP)
|Study Design:||Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Treatment
|Official Title:||Feasibility Trial of a Staged Epicardial & Endocardial Approach for Treatment of Patients With Persistent or Long Standing Persistent Atrial Fibrillation With Radiofrequency Ablation|
- Number of Patients With Pre-specified Safety Endpoints Occurring in the First 30 Days Post-index Procedure or Hospital Discharge, Whichever is Longer. [ Time Frame: 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.
- Number of Subjects With Absence of Atrial Fibrillation [ Time Frame: 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 Subjects With Serious Device or Procedure Related Adverse Event Rate [ Time Frame: 12 month follow-up ]
- Number of Subjects With Acute Procedure Success [ Time Frame: Day 0 ]
Defined as subject meeting all of the following criteria upon completion of the index-EP procedure
- Isolation/block of all pulmonary veins (e.g. 4 of 4 veins);
- Bi-directional cavotricuspid isthmus block;
- Isolation of Box (i.e. no capture outside ablation lines connecting roof and floor lines between right-and-left pulmonary vein isolation lines);
- Superior Vena Cava (SVC) isolation, if encircling SVC lesion performed.
- Number of Subject Without Atrial Fibrillation [ Time Frame: 6 and 12 month follow-up ]AF free with or without the need of antiarrhythmic drugs
- Number of Subjects With Reinterventions [ Time Frame: 12 month follow-up ]
- Number of Subjects With Direct Current (DC) Cardioversion [ Time Frame: 12 month follow-up ]
- Change in AF Based on AF Symptoms Checklist Frequency and Severity Scores [ Time Frame: 12 month follow-up ]
Change in Atrial Fibrillation Symptom Checklist Frequency and Severity Scores. This is reported as change from Baseline.
- 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.
- 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.
- Negative change from baseline compared to 12-months represents an improvement in AF symptomatology .
|Study Start Date:||August 2012|
|Study Completion Date:||December 2015|
|Primary Completion Date:||December 2015 (Final data collection date for primary outcome measure)|
Experimental: AtriCure Bipolar System combined with a catheter ablation
Minimally invasive procedure using the AtriCure Bipolar System plus a catheter ablation performed approximately 1-10 days apart
Device: Ablation procedure staged catheter ablation
AtriCure Bipolar System used in conjunction with a catheter ablation procedure performed 1-10 days apart
Please refer to this study by its ClinicalTrials.gov identifier: NCT01661205
|United States, California|
|Stanford University Medical Center|
|Stanford, California, United States, 94305|
|United States, Colorado|
|Colorado Springs Cardiology/Colorado Cardiac Alliance|
|Colorado Springs, Colorado, United States, 80907|
|United States, Tennessee|
|Vanderbilt Heart Institute|
|Nashville, Tennessee, United States, 37232|
|United States, Virginia|
|Sentara Norfolk Hospital|
|Norfolk, Virginia, United States, 23507|
|Universitair Ziekenhuis Brussel|
|Academic Medical Center|