Pivotal Study Of A Dual Epicardial & Endocardial Procedure (DEEP) Approach (DEEP)

November 26, 2024 updated by: AtriCure, Inc.

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
90

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Brussels, Belgium
        • Universitair Ziekenhuis Brussel (UZ Brussels)
  • Netherlands
      • Amsterdam, Netherlands
        • Academic Medical Center (AMC)
  • United States
    • California
      • Long Beach, California, United States, 90806
        • Long Beach Memorial Medical Center
      • Los Angeles, California, United States, 90048
        • Cedars-Sinai Heart Institute
      • Oakland, California, United States, 94609
        • Alta Bates Sutter Medical Center, East Bay Hospital
      • Saint Helena, California, United States, 94574
        • St. Helena Hospital, Adventist Heart Institute
      • Stanford, California, United States, 94305
        • Stanford University Department of CV medicine
    • Florida
      • Gainesville, Florida, United States, 32610
        • Shands at the University of Florida
      • Orlando, Florida, United States, 32806
        • Orlando Heart Institute
      • Sarasota, Florida, United States, 34239
        • Sarasota Memorial Hospital
    • Idaho
      • Boise, Idaho, United States, 83706
        • Saint Alphonsus Regional Medical Center
    • Ohio
      • Cincinnati, Ohio, United States, 45219
        • The Christ Hospital
      • Cincinnati, Ohio, United States
        • Tri Health Hosptial - Good Samaritan and Bethesda North Hospitals
    • Pennsylvania
      • Harrisburg, Pennsylvania, United States, 17104
        • Pinnacle Health
    • Virginia
      • Norfolk, Virginia, United States, 23507
        • Sentara Cardiovascular Research Institute
      • Richmond, Virginia, United States, 23298
        • Virginia Commonwealth University
    • Wisconsin
      • Wausau, Wisconsin, United States, 54401
        • Aspirus Research Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

1. Symptomatic Persistent Atrial Fibrillation or Longstanding Persistent Atrial Fibrillation refractory to a minimum of one Class I or Class III AADs.

Exclusion Criteria:

  1. AF >10 years.
  2. Refractory hypertension, defined as systolic (>150 mm Hg) or diastolic (> 90 mm Hg) blood pressure that remains uncontrolled despite sustained therapy
  3. History of pulmonary hypertension
  4. Pulmonary vein stenosis in one or more of the pulmonary veins
  5. EP catheter ablation procedure to treat atrial fibrillation within 3 months
  6. Undergone prior cardiothoracic surgery, previous thorax trauma which resulted in a pneumothorax or hemothorax.
  7. Sleep apnea, home oxygen therapy, moderate to severe COPD, (FEV1/FVC < 70% predicted) or patient is considered intolerant to single lung ventilation.
  8. NYHA Class IV heart failure.
  9. Uncorrected, reversible cause(s) of atrial fibrillation, or is currently being treated for arrhythmias other than atrial fibrillation (AF) or atrial flutter.
  10. Documented history of previous catheter ablation with perforation, history of pericarditis, pericardial effusion, or tamponade.
  11. Structural heart disease requiring surgical treatment (i.e. valve disease requiring repair or replacement within 12 months following surgical ablation procedure).
  12. CAD requiring intervention (either surgical, i.e. CABG, or catheter).
  13. Ejection fraction < 30%
  14. Measured left atrial diameter > 5.5 cm
  15. Stroke/cerebrovascular accident (CVA) within previous six months, carotid artery stenosis greater than 80%.
  16. BMI is >40
  17. Thrombus in the left atrium or the left atrial appendage, determined by echocardiography (either at baseline TTE (or equivalent diagnostic test) or intraoperative TEE).
  18. Blood dyscrasia or clotting disorder (i.e. Idiopathic Thrombocytopenic Purpura [ITP] or Thrombotic Thrombocytopenic Purpura [TTP]).
  19. Contraindication to anticoagulation that in the opinion of the investigator poses undue risk to the patient from participating in the endocardial EP procedure.
  20. Documented thromboembolism within the previous six months prior to signing informed consent.
  21. Has the following atrial myxoma, mural thrombus or mural tumor.
  22. A condition or congenital anomaly which prevents required surgical or catheter access.
  23. A co-morbid condition that, in the opinion of the investigator, poses undue risk of general anesthesia or port access cardiac surgery.
  24. Currently abusing drugs or alcohol.
  25. Currently or has participated in a clinical study in the last 3 months prior to signing informed consent.
  26. A psychological disorder that could interfere with provision of informed consent, completion of tests, therapy, or follow-up.
  27. A condition that, in the opinion of the investigator, may jeopardize the patient's well-being and/or the soundness of this clinical study.
  28. Pre-existing esophageal condition that required (or requires) endoscopic therapy or surgical treatment.

Study Plan

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

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: AtriCure Bipolar System and AtriClip® PRO LAA Exclusion System
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.
Device: AtriCure Bipolar System and AtriClip® PRO LAA Exclusion System, Endocardial Ablation
Other Names:
  • Irrigated Endocardial Catheters

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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).
6 months post the Endocaridal Ablation Procedure through the 12 month follow-up visit
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.
30 Days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
AtriCure, Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Kenneth Ellenbogen, MD, VCU
  • Principal Investigator: Vigneshwar Kasirajan, MD, VCU
  • Principal Investigator: Ali Khoynezhad, MD, MemorialCare Long Beach Medical Ctr

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 28, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 17, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 16, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 16, 2015

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 20, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 26, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CP2014-1

Drug and device information, study documents

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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