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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AtriCure, Inc.
ClinicalTrials.gov Identifier:
NCT01661205
First received: July 11, 2012
Last updated: April 7, 2017
Last verified: April 2017
  Purpose
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 Intervention
Atrial Fibrillation
Device: Ablation procedure staged catheter ablation

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by AtriCure, Inc.:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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

    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 [ 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.

    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 .


Enrollment: 30
Study Start Date: August 2012
Study Completion Date: December 2015
Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.
  Eligibility

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

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01661205

Locations
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
Belgium
Universitair Ziekenhuis Brussel
Brussel, Belgium
Netherlands
Academic Medical Center
Amsterdam, Netherlands
Sponsors and Collaborators
AtriCure, Inc.
  More Information

Responsible Party: AtriCure, Inc.
ClinicalTrials.gov Identifier: NCT01661205     History of Changes
Other Study ID Numbers: CP2012-1
Study First Received: July 11, 2012
Results First Received: February 7, 2017
Last Updated: April 7, 2017

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

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

ClinicalTrials.gov processed this record on May 25, 2017