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Completed

NCT Number: NCT01246466

Dual Epicardial Endocardial Persistent Atrial Fibrillation (AF) Study

The purpose of this clinical investigation is to evaluate how safe a less invasive cardiac surgery is using the AtriCure Bipolar System combined with a catheter ablation procedure in treating AF, and how effective this combined procedure is using the AtriCure System in treating AF. 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.

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Key information

Conditions

Persistent Atrial Fibrillation Arrhythmias, Cardiac Atrial Fibrillation Cardiovascular Diseases Heart Diseases Longstanding Persistent Atrial Fibrillation Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Stanford University Medical Center, Stanford, California, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age > 18 years
  • Patients with symptomatic (e.g. palpitations, shortness of breath, fatigue) persistent or longstanding persistent AF Persistent
  • Patient is willing and able to provide written informed consent.
  • Patient has a life expectancy of at least 2 years.
  • 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.
  • 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

Treatment and study plan

Hybrid: AtriCure Bipolar System & EP ablation procedure

Device

AtriCure Bipolar System plus a catheter ablation

Primary outcomes

  1. Primary Safety Endpoint

    Time frame: Within the first 30 days post-index procedure, or hospital discharge (up to 7 days), whichever is longer.

    Acute MAE within 30 days post procedure or hospital discharge (up to 7 days), whichever is longer.

  2. Absence of Atrial Fibrillation

    Time frame: 12 month follow-up

    Absence of atrial fibrillation (AF) at twelve month follow-up based on an auto trigger event monitor, while off all Class I and III antiarrhythmic therapy.

Secondary outcomes

  1. Overall Serious Device or Procedure Related Adverse Event Rate

    Time frame: 12 month follow-up

  2. Acute Procedure Success

    Time frame: Upon completion of the index procedure, up to ten hours

  3. Absence of Atrial Fibrillation

    Time frame: After the 3 month blanking period through twelve month follow-up.

    Absence of atrial fibrillation after the 3 month blanking period through twelve month follow-up based on auto trigger event monitor.

  4. Number of Participants With Reintervention to Address Atrial Dysrhythmia

    Time frame: 12 months

    Number of Participants with Reintervention to Address Atrial Dysrhythmia, through 12 months

  5. Number of Participants With DC Cardioversion

    Time frame: 12 months

  6. Improvement in AF

    Time frame: 12 months

    Improvement in Atrial Fibrillation Symptom Checklist Frequency (Minimum value: -1.0, Maximum value: 25.0) and Severity Scores (Minimum value: -6.0, Maximum value: 19.0)

  7. Duration of Procedure

    Time frame: During index procedure

Sponsors and collaborators

Lead sponsor

AtriCure, Inc.

Industry

Registry information

Official study title

Feasibility Trial of a Hybrid Approach for Treatment of Patients With Persistent or Longstanding Persistent Atrial Fibrillation With Radiofrequency Ablation

Acronym: DEEP

Important dates

Study start
2010
Primary completion
2012
Study completion
2013
First posted
Nov 23, 2010
Registry last updated
Apr 1, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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