Atrial FibrillationDEEPNCT02393885
Pivotal Study Of A Dual Epicardial & Endocardial Procedure (DEEP) Approach
A study testing AtriCure Bipolar System and AtriClip® PRO LAA Exclusion System, Endocardial Ablation in people with Atrial Fibrillation and Persistent or Longstanding Persistent Atrial Fibrillation, run by AtriCure, Inc. at 17 sites in 3 countries.
Trial summary
The objective of this study is to establish the safety and effectiveness of a dual epicardial and endocardial ablation procedure for patients presenting with Persistent Atrial Fibrillation or Longstanding Persistent Atrial Fibrillation Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Atrial Fibrillation, Persistent or Longstanding Persistent Atrial Fibrillation
- What is being tested?
- AtriCure Bipolar System and AtriClip® PRO LAA Exclusion System, Endocardial Ablation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 17 sitesin 3 countries
- Study dates
- Feb 2015to 17 Apr 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. Symptomatic Persistent Atrial Fibrillation or Longstanding Persistent Atrial Fibrillation refractory to a minimum of one Class I or Class III AADs.
Who cannot join
- AF >10 years.
- Refractory hypertension, defined as systolic (>150 mm Hg) or diastolic (> 90 mm Hg) blood pressure that remains uncontrolled despite sustained therapy
- History of pulmonary hypertension
- Pulmonary vein stenosis in one or more of the pulmonary veins
- EP catheter ablation procedure to treat atrial fibrillation within 3 months
- Undergone prior cardiothoracic surgery, previous thorax trauma which resulted in a pneumothorax or hemothorax.
Show all 28Show fewer
- Sleep apnea, home oxygen therapy, moderate to severe COPD, (FEV1/FVC < 70% predicted) or patient is considered intolerant to single lung ventilation.
- NYHA Class IV heart failure.
- Uncorrected, reversible cause(s) of atrial fibrillation, or is currently being treated for arrhythmias other than atrial fibrillation (AF) or atrial flutter.
- Documented history of previous catheter ablation with perforation, history of pericarditis, pericardial effusion, or tamponade.
- Structural heart disease requiring surgical treatment (i.e. valve disease requiring repair or replacement within 12 months following surgical ablation procedure).
- CAD requiring intervention (either surgical, i.e. CABG, or catheter).
- Ejection fraction < 30%
- Measured left atrial diameter > 5.5 cm
- Stroke/cerebrovascular accident (CVA) within previous six months, carotid artery stenosis greater than 80%.
- BMI is >40
- Thrombus in the left atrium or the left atrial appendage, determined by echocardiography (either at baseline TTE (or equivalent diagnostic test) or intraoperative TEE).
- Blood dyscrasia or clotting disorder (i.e. Idiopathic Thrombocytopenic Purpura [ITP] or Thrombotic Thrombocytopenic Purpura [TTP]).
- Contraindication to anticoagulation that in the opinion of the investigator poses undue risk to the patient from participating in the endocardial EP procedure.
- Documented thromboembolism within the previous six months prior to signing informed consent.
- Has the following atrial myxoma, mural thrombus or mural tumor.
- A condition or congenital anomaly which prevents required surgical or catheter access.
- A co-morbid condition that, in the opinion of the investigator, poses undue risk of general anesthesia or port access cardiac surgery.
- Currently abusing drugs or alcohol.
- Currently or has participated in a clinical study in the last 3 months prior to signing informed consent.
- A psychological disorder that could interfere with provision of informed consent, completion of tests, therapy, or follow-up.
- A condition that, in the opinion of the investigator, may jeopardize the patient's well-being and/or the soundness of this clinical study.
- Pre-existing esophageal condition that required (or requires) endoscopic therapy or surgical treatment.
Trial locations and contacts
17 sites in 3 countries.
17 sites in 3 countries
United States15 sites
Saint Alphonsus Regional Medical Center
Boise, Idaho, 83706
The Christ Hospital
Cincinnati, Ohio, 45219
Tri Health Hosptial - Good Samaritan and Bethesda North Hospitals
Cincinnati, Ohio
Shands at the University of Florida
Gainesville, Florida, 32610
Pinnacle Health
Harrisburg, Pennsylvania, 17104
Long Beach Memorial Medical Center
Long Beach, California, 90806
Cedars-Sinai Heart Institute
Los Angeles, California, 90048
Sentara Cardiovascular Research Institute
Norfolk, Virginia, 23507
Alta Bates Sutter Medical Center, East Bay Hospital
Oakland, California, 94609
Orlando Heart Institute
Orlando, Florida, 32806
Virginia Commonwealth University
Richmond, Virginia, 23298
Sarasota Memorial Hospital
Sarasota, Florida, 34239
St. Helena Hospital, Adventist Heart Institute
St. Helena, California, 94574
Stanford University Department of CV medicine
Stanford, California, 94305
Aspirus Research Institute
Wausau, Wisconsin, 54401
About this study
Official title: Pivotal Study Of A Dual Epicardial & Endocardial Procedure (DEEP) Approach for Treatment of Subjects With Persistent or Long Standing Persistent Atrial Fibrillation With Radiofrequency Ablation
The objective of this study is to establish the safety and effectiveness of a dual epicardial and endocardial ablation procedure for patients presenting with Persistent Atrial Fibrillation or Longstanding Persistent Atrial Fibrillation
Read the detailed description
The objective of this study is to establish the safety and effectiveness of a dual epicardial and endocardial ablation procedure for patients presenting with Persistent Atrial Fibrillation or Longstanding Persistent Atrial Fibrillation utilizing the AtriCure Bipolar System and AtriClip® PRO LAA Exclusion System in an endoscopic or open ablation procedure, followed by an endocardial mapping and ablation procedure utilizing commercially available RF based, irrigated, power controlled, ablation catheters for endocardial lesions. The endocardial procedure will be staged to occur after 90 days post epicardial surgical procedure.
- Being tested
- AtriCure Bipolar System and AtriClip® PRO LAA Exclusion System, Endocardial Ablation
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AtriCure Bipolar System and AtriClip® PRO LAA Exclusion System, Endocardial AblationDevice
Also called Irrigated Endocardial Catheters
| Study group | Role | What they receive |
|---|---|---|
| AtriCure Bipolar System and AtriClip® PRO LAA Exclusion System | Experimental | 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. Receives: Device: AtriCure Bipolar System and AtriClip® PRO LAA Exclusion System, Endocardial Ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Effectiveness Endpoint
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 AADs at doses not exceeding those previously failed).
Measured: 6 months post the Endocaridal Ablation Procedure through the 12 month follow-up visit
Primary Safety Endpoint
The primary safety endpoint is a composite endpoint consisting of any one or more of the events if they were adjudicated by the CEC to be serious adverse events (SAEs) and related to device/procedures as follows:
- The AtriCure Bipolar System and/or the AtriClip Pro LAA Exclusion System, within 30 days following the epicardial surgical ablation procedure; or
- The epicardial surgical ablation procedure within 30 days following the epicardial procedure; or
- The endocardial index procedure (or a repeat endocardial ablation procedure performed during the blanking period) within 7 days following an endocardial ablation procedure.
Measured: 30 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2015 (estimated)
- Study startFeb 2015
- Primary completion28 Mar 2022
- Study completion17 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- AtriCure, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kenneth Ellenbogen, MD, Principal investigator, VCUVigneshwar Kasirajan, MD, Principal investigator, VCUAli Khoynezhad, MD, Principal investigator, MemorialCare Long Beach Medical Ctr
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02393885
- Sponsor's protocol ID
- CP2014-1
- Acronym
- DEEP
- Status last verified
- May 2024
- First submitted
- 16 Mar 2015
- Last updated
- 19 Dec 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated device
- Yes
Publications
Ellenbogen KA, Khoynezhad A, La Meir M, de Asmundis C, Koneru JN, Johnkoski J, Rist K, Mumtaz M, Link MG, de Groot JR, Driessen AHG, Lee MY, Hoff SJ, Bello D, Dunnington G, Eisenberg S, Vloka M, Taylor BJ, Jones SD, Philpott JM, Beaver TM, Miles WM, Khan JH, Kang S, Gandhi GD, Okum EJ, Badhwar N, Baykaner T, Lee AM, Vesco PA, Smith JM, Gaynor S, Frazier K, Lee RJ, Kasirajan V. Dual Epicardial and Endocardial Procedure (DEEP) for Persistent or Longstanding Persistent Atrial Fibrillation. Circ Arrhythm Electrophysiol. 2025 Oct;18(10):e013692. doi: 10.1161/CIRCEP.125.013692. Epub 2025 Sep 30.
PubMed 41025224
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pivotal Study Of A Dual Epicardial & Endocardial Procedure (DEEP) Approach for Treatment of Subjects With Persistent or Long Standing Persistent Atrial Fibrillation With Radiofrequency Ablation
- ClinicalTrials.gov ID
- NCT02393885
- Acronym / sponsor ID
- DEEP / CP2014-1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- AtriCure, Inc.Industry (pharma, biotech, devices)
- Study start
- Feb 2015 (actual)
- Primary completion
- 28 Mar 2022 (actual)
- Study completion
- 17 Apr 2024 (actual)
- First posted
- 20 Mar 2015 (estimated)
- Results
- Posted 19 Dec 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this study is to establish the safety and effectiveness of a dual epicardial and endocardial ablation procedure for patients presenting with Persistent Atrial Fibrillation or Longstanding Persistent Atrial Fibrillation
Detailed description
The objective of this study is to establish the safety and effectiveness of a dual epicardial and endocardial ablation procedure for patients presenting with Persistent Atrial Fibrillation or Longstanding Persistent Atrial Fibrillation utilizing the AtriCure Bipolar System and AtriClip® PRO LAA Exclusion System in an endoscopic or open ablation procedure, followed by an endocardial mapping and ablation procedure utilizing commercially available RF based, irrigated, power controlled, ablation catheters for endocardial lesions. The endocardial procedure will be staged to occur after 90 days post epicardial surgical procedure.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AtriCure Bipolar System and AtriClip® PRO LAA Exclusion System | Experimental | Device: AtriCure Bipolar System and AtriClip® PRO LAA Exclusion System, Endocardial AblationAtriCure 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 1. Symptomatic Persistent Atrial Fibrillation or Longstanding Persistent Atrial Fibrillation refractory to a minimum of one Class I or Class III AADs.
Key exclusion criteria (28 listed)
- AF >10 years.
- Refractory hypertension, defined as systolic (>150 mm Hg) or diastolic (> 90 mm Hg) blood pressure that remains uncontrolled despite sustained therapy
- History of pulmonary hypertension
- Pulmonary vein stenosis in one or more of the pulmonary veins
- EP catheter ablation procedure to treat atrial fibrillation within 3 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AtriCure Bipolar System and AtriClip® PRO LAA Exclusion System, Endocardial AblationAlso: Irrigated Endocardial Catheters | Device | AtriCure Bipolar System and AtriClip® PRO LAA Exclusion System |
Primary outcome
Primary Effectiveness Endpoint
Time frame: 6 months post the Endocaridal Ablation Procedure through the 12 month follow-up visit
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 AADs at doses not exceeding those previously failed).
Primary Safety Endpoint
Time frame: 30 Days
The primary safety endpoint is a composite endpoint consisting of any one or more of the events if they were adjudicated by the CEC to be serious adverse events (SAEs) and related to device/procedures as follows: 1. The AtriCure Bipolar System and/or the AtriClip Pro LAA Exclusion System, within 30 days following the epicardial surgical ablation procedure; or 2. The epicardial surgical ablation procedure within 30 days following the epicardial procedure; or 3. The endocardial index procedure (or a repeat endocardial ablation procedure performed during the blanking period) within 7 days following an endocardial ablation procedure.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 41025224Ellenbogen KA, Khoynezhad A, La Meir M, de Asmundis C, Koneru JN, Johnkoski J, Rist K, Mumtaz M, Link MG, de Groot JR, Driessen AHG, Lee MY, Hoff SJ, Bello D, Dunnington G, Eisenberg S, Vloka M, Taylor BJ, Jones SD, Philpott JM, Beaver TM, Miles WM, Khan JH, Kang S, Gandhi GD, Okum EJ, Badhwar N, Baykaner T, Lee AM, Vesco PA, Smith JM, Gaynor S, Frazier K, Lee RJ, Kasirajan V. Dual Epicardial and Endocardial Procedure (DEEP) for Persistent or Longstanding Persistent Atrial Fibrillation. Circ Arrhythm Electrophysiol. 2025 Oct;18(10):e013692. doi: 10.1161/CIRCEP.125.013692. Epub 2025 Sep 30.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kenneth Ellenbogen, MD principal investigator
VCU
Vigneshwar Kasirajan, MD principal investigator
VCU
Ali Khoynezhad, MD principal investigator
MemorialCare Long Beach Medical Ctr
17 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AtriCure Bipolar System and AtriClip® PRO LAA Exclusion System, Endocardial Ablation in people with Atrial Fibrillation and Persistent or Longstanding Persistent Atrial Fibrillation, run by AtriCure, Inc. at 17 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in United States, Belgium, Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Dec 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Effectiveness Endpoint (time frame: 6 months post the Endocaridal Ablation Procedure through the 12 month follow-up visit). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02393885, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2024.