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Procedure
DEEP Ablation for Atrial Fibrillation (DEEP Trial)
N/A
Waitlist Available
Led By Vigneshwar Kasirajan, MD
Research Sponsored by AtriCure, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Symptomatic Persistent Atrial Fibrillation or Longstanding Persistent Atrial Fibrillation refractory to a minimum of one Class I or Class III AADs.
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months post the endocaridal ablation procedure through the 12 month follow-up visit
Awards & highlights
DEEP Trial Summary
This trial is testing a new ablation procedure for atrial fibrillation that targets both the inside and outside of the heart. The goal is to see if it is safe and effective.
Who is the study for?
This trial is for patients with Persistent or Longstanding Persistent Atrial Fibrillation who haven't responded to certain heart rhythm medications. It's not suitable for individuals with a BMI over 40, recent thromboembolism, severe clotting disorders, risks from general anesthesia or surgery, drug/alcohol abuse, psychological issues affecting consent and follow-up, specific heart conditions like severe valve disease or CAD needing intervention, extreme pulmonary issues, or those treated for arrhythmias other than AF.Check my eligibility
What is being tested?
The study tests the safety and effectiveness of combining two procedures—AtriCure Bipolar System (epicardial ablation) and Endocardial Ablation—for treating persistent types of atrial fibrillation that don't respond well to medication. The goal is to see if this dual approach can better manage irregular heartbeats.See study design
What are the potential side effects?
Potential side effects may include complications related to ablation such as bleeding at the site of surgery, infection risk from incisions made during the procedure(s), possible damage to surrounding tissues including nerves or blood vessels near the heart; there might also be general risks associated with anesthesia.
DEEP Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My heart condition hasn't improved despite taking specific heart rhythm medications.
DEEP Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 months post the endocaridal ablation procedure through the 12 month follow-up visit
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months post the endocaridal ablation procedure through the 12 month follow-up visit
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Freedom from any documented AF, atrial flutter, or atrial tachycardia lasting >30 seconds in duration through the 12 month follow-up visit in the absence of Class I or III AADs (with the exception of previously failed
DEEP Trial Design
1Treatment groups
Experimental Treatment
Group I: AtriCure Bipolar System and AtriClip® PRO LAA Exclusion SystemExperimental Treatment1 Intervention
AtriCure Bipolar System and AtriClip® PRO LAA Exclusion System at day 1 of surgical procedure followed by endocardial catheter ablation procedure to occur at approximately 90 days after day 1 of surgical procedure.
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Who is running the clinical trial?
AtriCure, Inc.Lead Sponsor
41 Previous Clinical Trials
17,251 Total Patients Enrolled
27 Trials studying Atrial Fibrillation
8,207 Patients Enrolled for Atrial Fibrillation
Vigneshwar Kasirajan, MDPrincipal InvestigatorVCU
2 Previous Clinical Trials
106 Total Patients Enrolled
1 Trials studying Atrial Fibrillation
106 Patients Enrolled for Atrial Fibrillation
Ali Khoynezhad, MDPrincipal InvestigatorMemorialCare Long Beach Medical Ctr
3 Previous Clinical Trials
409 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a blood clot in a specific part of your heart, as seen on an ultrasound test.I have had complications from a heart procedure, including heart lining issues.I have severe heart failure.Your left atrial diameter is larger than 5.5 cm when measured.I have a history of high blood pressure in the lungs.I had a procedure to correct heart rhythm issues within the last 3 months.I have a tumor or clot in my heart.I have a blood disorder like ITP or TTP.I have an esophageal condition that needed or needs surgery or endoscopy.My high blood pressure is not controlled despite taking medication.I have had chest surgery or chest injury that caused lung or chest bleeding.My heart condition hasn't improved despite taking specific heart rhythm medications.You have a medical condition or birth defect that makes it difficult to perform necessary surgery or use a catheter.My BMI is over 40.I have had a blood clot in the past 6 months.I have had surgery or a procedure for my heart disease.I have severe breathing issues, such as sleep apnea or COPD.I haven't had a stroke or severe narrowing of my neck arteries in the last 6 months.Your heart is not pumping enough blood.I have had atrial fibrillation for more than 10 years.You have a mental health condition that could make it hard for you to understand the study or complete the required tasks.I have a narrowed vein in my lung.I have atrial fibrillation not caused by a treatable condition, or I'm treated for another heart rhythm problem.I need heart surgery for a valve problem within a year after my ablation procedure.You have a medical condition that the doctor thinks could make anesthesia or heart surgery too risky for you.You are currently using drugs or drinking alcohol excessively.
Research Study Groups:
This trial has the following groups:- Group 1: AtriCure Bipolar System and AtriClip® PRO LAA Exclusion System
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Atrial Fibrillation Patient Testimony for trial: Trial Name: NCT02393885 — N/A
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Who is eligible for this research trial?
"This clinical trial is seeking 220 individuals with atrial fibrillation who are between 18 and 75 years of age. To be eligible, patients must have symptomatic persistent or long-standing persistent atrial fibrillation that has not responded to one class I or III antiarrhythmic drugs (AADs)."
Answered by AI
Are there any vacancies for prospective participants in this experiment?
"Per clinicaltrials.gov, this study has ended recruitment after being first posted on February 1st 2015 and last edited on May 19th 2022. However, 477 other trials are recruiting participants presently."
Answered by AI
How many sites are managing this research endeavor?
"This trial is being executed in a dozen different medical centres, including Stanford University Department of CV Medicine, Tri Health Hosptial - Good Samaritan and Bethesda North Hospitals in Cincinnati, Long Beach Memorial Medical Center, and other sites."
Answered by AI
Is the eligibility criteria for this clinical trial restricted to individuals older than 80 years?
"As stated by the inclusion criteria, this clinical trial is recruiting patients between 18 and 75 years of age. There are 11 studies available for minors while 474 medical trials focus on geriatric populations."
Answered by AI
Who else is applying?
What state do they live in?
California
What site did they apply to?
St. Helena Hospital, Adventist Heart Institute
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0
Why did patients apply to this trial?
I’ve been dealing with Afib for 3 years. It was controlled somewhat for over 2 years with minimal episodes. Since then it has become persistent 24/7.
PatientReceived no prior treatments
What questions have other patients asked about this trial?
How invasive is this procedure? How long are you under anesthesia? What is the recovery time?
PatientReceived 1 prior treatment
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