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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01661205
Recruitment Status : Completed
First Posted : August 9, 2012
Results First Posted : May 17, 2017
Last Update Posted : May 17, 2017
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Atrial Fibrillation Device: Ablation procedure staged catheter ablation Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
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
Study Start Date : August 2012
Actual Primary Completion Date : December 2015
Actual Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. 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.

  2. 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.

Secondary Outcome Measures :
  1. Number Subjects With Serious Device or Procedure Related Adverse Event Rate [ Time Frame: 12 month follow-up ]
  2. 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

    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.

  3. Number of Subject Without Atrial Fibrillation [ Time Frame: 6 and 12 month follow-up ]
    AF free with or without the need of antiarrhythmic drugs

  4. Number of Subjects With Reinterventions [ Time Frame: 12 month follow-up ]
  5. Number of Subjects With Direct Current (DC) Cardioversion [ Time Frame: 12 month follow-up ]
  6. 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.

    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 .

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

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 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
Brussel, Belgium
Academic Medical Center
Amsterdam, Netherlands
Sponsors and Collaborators
AtriCure, Inc.

Responsible Party: AtriCure, Inc. Identifier: NCT01661205     History of Changes
Other Study ID Numbers: CP2012-1
First Posted: August 9, 2012    Key Record Dates
Results First Posted: May 17, 2017
Last Update Posted: May 17, 2017
Last Verified: April 2017

Keywords provided by AtriCure, Inc.:
Persistent AF
Longstanding Persistent AF
catheter ablation

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes