Completed

Staged DEEPFeasibility Trial of a Staged Epicardial & Endocardial Approach for Treatment of Patients With Persistent or Long Standing Persistent Atrial Fibrillation With Radiofrequency Ablation

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being tested

Ablation procedure staged catheter ablation

Device
Who is being recruted

Arrhythmias, Cardiac+3

+ Cardiovascular Diseases

+ Heart Diseases

Over 18 Years
+22 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
Study Start: August 2012
See protocol details

Summary

Principal SponsorAtriCure, Inc.
Last updated: May 17, 2017
Sourced from a government-validated database.Claim as a partner

Study start date: August 1, 2012

Actual date on which the first participant was enrolled.

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.

NCT01661205
Principal SponsorAtriCure, Inc.
Last updated: May 17, 2017
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

30 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Arrhythmias, CardiacCardiovascular DiseasesHeart DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsAtrial Fibrillation

Criteria

6 inclusion criteria required to participate
Age > 18 year
Life expectancy of at least two years
Patient is willing and able to attend the scheduled follow-up visits
Patient will and able to provide informed consent
Show More Criteria
16 exclusion criteria prevent from participating
Contraindication to anticoagulation, based on Investigator's opinion
Ejection fraction < 30%
Evidence of significant active infection or endocarditis
Evidence of underlying structural heart disease requiring surgical treatment
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

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

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 6 locations

Stanford University Medical Center

Stanford, United StatesOpen Stanford University Medical Center in Google Maps

Colorado Springs Cardiology/Colorado Cardiac Alliance

Colorado Springs, United States

Vanderbilt Heart Institute

Nashville, United States

Sentara Norfolk Hospital

Norfolk, United States
Completed6 Study Centers