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

Primary Purpose

Atrial Fibrillation

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Ablation procedure staged catheter ablation
Sponsored by
AtriCure, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atrial Fibrillation focused on measuring Persistent AF, Longstanding Persistent AF, Ablation, catheter ablation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Stanford University Medical Center
  • Colorado Springs Cardiology/Colorado Cardiac Alliance
  • Vanderbilt Heart Institute
  • Sentara Norfolk Hospital
  • Universitair Ziekenhuis Brussel
  • Academic Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

AtriCure Bipolar System combined with a catheter ablation

Arm Description

Minimally invasive procedure using the AtriCure Bipolar System plus a catheter ablation performed approximately 1-10 days apart

Outcomes

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.
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
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
Number of Subjects With Acute Procedure Success
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
AF free with or without the need of antiarrhythmic drugs
Number of Subjects With Reinterventions
Number of Subjects With Direct Current (DC) Cardioversion
Change in AF Based on AF Symptoms Checklist Frequency and Severity Scores
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 .

Full Information

First Posted
July 11, 2012
Last Updated
April 7, 2017
Sponsor
AtriCure, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01661205
Brief Title
Dual Epicardial Endocardial Persistent Atrial Fibrillation(AF) Study (Staged DEEP)
Acronym
Staged DEEP
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 Type
Interventional

2. Study Status

Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
August 2012 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
December 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AtriCure, Inc.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation
Keywords
Persistent AF, Longstanding Persistent AF, Ablation, catheter ablation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
AtriCure Bipolar System combined with a catheter ablation
Arm Type
Experimental
Arm Description
Minimally invasive procedure using the AtriCure Bipolar System plus a catheter ablation performed approximately 1-10 days apart
Intervention Type
Device
Intervention Name(s)
Ablation procedure staged catheter ablation
Intervention Description
AtriCure Bipolar System used in conjunction with a catheter ablation procedure performed 1-10 days apart
Primary Outcome Measure Information:
Title
Number of Patients With Pre-specified Safety Endpoints Occurring in the First 30 Days Post-index Procedure or Hospital Discharge, Whichever is Longer.
Description
Pre-specified events include: Death; Myocardial Infarction; Stroke or TIA; Excess bleeding; Pulmonary vein stenosis; atrio-esophagael fistula; phrenic nerve paralysis; Pericardial effusion; Embolisms.
Time Frame
30 days post-index procedure or hospital discharge
Title
Number of Subjects With Absence of Atrial Fibrillation
Description
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.
Time Frame
12 month follow-up
Secondary Outcome Measure Information:
Title
Number Subjects With Serious Device or Procedure Related Adverse Event Rate
Time Frame
12 month follow-up
Title
Number of Subjects With Acute Procedure Success
Description
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.
Time Frame
Day 0
Title
Number of Subject Without Atrial Fibrillation
Description
AF free with or without the need of antiarrhythmic drugs
Time Frame
6 and 12 month follow-up
Title
Number of Subjects With Reinterventions
Time Frame
12 month follow-up
Title
Number of Subjects With Direct Current (DC) Cardioversion
Time Frame
12 month follow-up
Title
Change in AF Based on AF Symptoms Checklist Frequency and Severity Scores
Description
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 .
Time Frame
12 month follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Stanford University Medical Center
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
Facility Name
Colorado Springs Cardiology/Colorado Cardiac Alliance
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80907
Country
United States
Facility Name
Vanderbilt Heart Institute
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Facility Name
Sentara Norfolk Hospital
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23507
Country
United States
Facility Name
Universitair Ziekenhuis Brussel
City
Brussel
Country
Belgium
Facility Name
Academic Medical Center
City
Amsterdam
Country
Netherlands

12. IPD Sharing Statement

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

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