Dual Epicardial Endocardial Persistent Atrial Fibrillation(AF) Study (Staged DEEP) (Staged DEEP)
|ClinicalTrials.gov Identifier: NCT01661205|
Recruitment Status : Completed
First Posted : August 9, 2012
Results First Posted : May 17, 2017
Last Update Posted : May 17, 2017
|Condition or disease||Intervention/treatment||Phase|
|Atrial Fibrillation||Device: Ablation procedure staged catheter ablation||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||August 2012|
|Actual Primary Completion Date :||December 2015|
|Actual Study Completion Date :||December 2015|
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
- 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 .
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|