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

Atrial Fibrillation Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01661205
• Other study ID #: CP2012-1
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: July 11, 2012
• Last updated: January 4, 2016
• Start date: August 2012
• Est. completion date: December 2015

Study information

• Verified date: January 2016
• Source: AtriCure, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited States: Institutional Review BoardBelgium: Ethics CommitteeNetherlands: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age > 18 year

• Patients with symptomatic persistent or longstanding persistent AF refractory to a minimum of one Class I or III AAD(s).

• 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 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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Device:
• Ablation procedure staged catheter ablation
AtriCure Bipolar System used in conjunction with a catheter ablation procedure performed 1-10 days apart

Locations

Country	Name	City	State
Belgium	Universitair Ziekenhuis Brussel	Brussel
Netherlands	Academic Medical Center	Amsterdam
United States	Colorado Springs Cardiology/Colorado Cardiac Alliance	Colorado Springs	Colorado
United States	Vanderbilt Heart Institute	Nashville	Tennessee
United States	Sentara Norfolk Hospital	Norfolk	Virginia
United States	Stanford University Medical Center	Stanford	California

Sponsors (1)

Lead Sponsor	Collaborator
AtriCure, Inc.

Countries where clinical trial is conducted

United States,  Belgium,  Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients with pre-specified safety endpoints occurring in the first 30 days post-index procedure or hospital discharge, whichever is longer.		30 days post-index procedure or hospital discharge	Yes
Primary	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.	12 month follow-up	No
Secondary	Number of Overall Serious Device or Procedure Related Adverse Event Rate		12 month follow-up	Yes
Secondary	Number of subjects with Acute Procedure Success	Index procedure	Day 0	No
Secondary	Number of subject without atrial fibrillation	AF free with or without the need of antiarrhythmic drugs	6 and 12 month follow-up	No
Secondary	Number of Reinterventions		12 month follow-up	No
Secondary	Number of DC cardioversion		12 month follow-up	No
Secondary	Improvement in AF based on AF Symptoms Checklist Frequency and Severity Scores	Improvement in AF Symptom Checklist Frequency and Severity Scores.	12 month follow-up	No