Efficacy and Safety Study of the Estech COBRA® Surgical System to Treat Patients With a History of Irregular Heart Beats

April 22, 2014 updated by: Endoscopic Technologies, Inc

Ablation for the Treatment of Concomitant Atrial Fibrillation in Non-Paroxysmal Patients (ATTAC-AF)

The purpose of this study is to demonstrate that the Estech COBRA Surgical System is an effective treatment for patients with irregular heart beats who are undergoing heart surgery.

Study Overview

Status

Status

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

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 the trial is to demonstrate that the creation of epicardial and endocardial lesions with temperature-controlled radiofrequency (TCRF) ablation applied using the Estech COBRA® Surgical System during concomitant heart surgery is a safe and effective treatment for non-paroxysmal atrial fibrillation (AF).

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.
6

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

  • United States
    • Arizona
      • Mesa, Arizona, United States, 85206
        • Banner Good Samaritan Medical Center
    • Connecticut
      • Hartford, Connecticut, United States, 06102
        • Hartford Hospital
    • Georgia
      • Atlanta, Georgia, United States, 30342
        • Saint Joseph's Hospital of Atlanta
    • Illinois
      • Evanston, Illinois, United States, 60201
        • North Shore Univ. Health System
      • Oak Lawn, Illinois, United States, 60453
        • Advocate Christ Medical Center
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • The Univ. of Kansas Hospital
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • Univ. of Michigan Cardiovascular Center
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic / St. Mary's Hospital
    • New York
      • New York, New York, United States, 10075
        • Lenox Hill Hospital / North Shore-LIJ Health System
      • Utica, New York, United States, 13501
        • Mohawk Valley Heart Institute / St. Elizabeth Medical Center
    • South Carolina
      • Columbia, South Carolina, United States, 29204
        • Sisters of Charity, Providence Hospital
    • Virginia
      • Falls Church, Virginia, United States, 22041
        • Fairfax Hospital, Department of Cardiovascular and Thoracic Surgery
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53215
        • Aurora St. Luke's Medical Center

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 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

All subjects are required to meet the following inclusion criteria in order to be considered eligible for participation in this trial:

  1. Subject is scheduled to undergo elective on-pump cardiac surgical procedure(s) for one or more of the following:

    1. Mitral valve repair or replacement,
    2. Aortic valve repair or replacement,
    3. Tricuspid valve repair or replacement, or
    4. Coronary Artery Bypass procedures;
  2. Subject has history of a non-paroxysmal form of AF for greater than 3 months and has failed at least one attempt at electrical cardioversion or had a successful attempt at electrical cardioversion but had a recurrence of AF within 30 days of the cardioversion;
  3. Age 18 to 80 years old;
  4. Left ventricular ejection fraction (LVEF) ≥ 30%;
  5. Subject has no contraindications to intraoperative transesophageal echocardiography;
  6. Subject has a life expectancy greater than 12 months; and
  7. Willing and capable of providing Informed Consent to undergo surgery and participate in all examinations and follow-ups associated with this clinical trial.

A subject is considered to have failed electrical cardioversion if they did not achieve sinus rhythm for at least 30 seconds following the attempted cardioversion.

Exclusion Criteria:

Subjects will be excluded from participating in this trial if they meet any of the following exclusion criteria:

  1. History of non-paroxysmal AF less than 3 months or for more than 5 years;
  2. History of prior cardiac ablative surgical or catheter-based therapy;
  3. Previous cardiac surgery (redo) or other intrapericardial procedures;
  4. Class IV NYHA heart failure;
  5. Known carotid artery stenosis greater than 80% or previous carotid endarterectomy;
  6. Wolff-Parkinson-White syndrome;
  7. Need for emergent cardiac surgery (e.g., cardiogenic shock);
  8. Untreated hyperthyroidism;
  9. Untreated hypothyroidism;
  10. Acute pulmonary disease;
  11. Electrolyte imbalance;
  12. History of myocarditis;
  13. Presence of a previously implanted device in or adjacent to the treatment target area that may alter the delivery of therapy (e.g., valvular prosthesis or ring, pacemaker with leads in coronary sinus or internal defibrillator leads);
  14. History of pericarditis;
  15. Previous left phrenic nerve paralysis;
  16. Bullous lung disease;
  17. Presence of active endocarditis, or local or systemic infection;
  18. Recent myocardial infarction (< 3 months);
  19. Renal failure requiring dialysis or hepatic failure or creatinine of >2 mg/dL preoperatively;
  20. Antiarrhythmic drug therapy required for the treatment of a ventricular arrhythmia;
  21. Preoperative need for an intra-aortic balloon pump or intravenous inotropes;
  22. Severe peripheral arterial occlusive disease defined as claudication with minimal exertion;
  23. Therapy resulting in compromised tissue integrity including: thoracic radiation, chemotherapy, long term treatment with oral or injected steroids, or known connective tissue disorders;
  24. Documented left atrial size of 6 cm or more;
  25. History of cerebrovascular disease or accident, including stroke or transient ischemic attack (TIA) within 6 months prior to enrollment;
  26. Known contraindication to anticoagulant therapy or inability to comply with anticoagulant therapy;
  27. Pregnancy, planned pregnancy (females of childbearing potential must have a negative pregnancy test prior to enrollment and agree not to become pregnant during the trial) or breastfeeding;
  28. Forced expiratory volume in 1 second less than 30% of predicted value or need for home oxygen therapy; or
  29. Surgical management of hypertrophic obstructive cardiomyopathy.

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: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

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: The Estech COBRA® Surgical System
Device: The Estech COBRA® Surgical System
The Estech COBRA® Surgical System has been designed to create epicardial and endocardial lesions on the heart using temperature controlled radiofrequency (TCRF) ablation with the Estech COBRA surgical probes. Temperature control provides a meaningful endpoint, maintaining tissue at safe yet effective temperatures to produce the desired lesion set. Internal probe cooling and advanced suction helps to ensure reproducible transmural (full-thickness) endocardial or epicardial lesions.
Other Names:
  • Estech COBRA Cooled™ Surgical Probe
  • Estech COBRA Adhere™ XL Surgical System
  • Estech COBRA Adhere™ XL 2 Surgical System
  • Estech COBRA® Revolution Bipolar Clamp

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 Efficacy Endpoint
Time Frame: The primary efficacy endpoint will be assessed following the blanking interval through Month 12.
Proportion of subjects that achieve procedural and therapeutic success. Procedural success is defined as the performance of the protocol specified lesions with the designated devices. Therapeutic success is defined as freedom from AF, AFL (atrial flutter) and AT (atrial tachycardia, not including sinus tachycardia) following the blanking interval through Month 12.
The primary efficacy endpoint will be assessed following the blanking interval through Month 12.
Primary Safety Endpoint
Time Frame: The primary safety endpoint will be assessed within 30 days of the procedure or hospital discharge, whichever is later.

A composite safety endpoint consisting of the proportion of subjects that experience one or more of the following early onset (i.e., within 30 days of the TCRF ablation procedure or hospital discharge, whichever is later) serious adverse events (SAEs):

  • Cardiac death;
  • Stroke and transient ischemic attack (TIA);
  • Myocardial infarction (MI);
  • Excessive bleeding; or
  • Atrioesophageal fistula.
The primary safety endpoint will be assessed within 30 days of the procedure or hospital discharge, whichever is later.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Secondary Efficacy Endpoint
Time Frame: The secondary efficacy endpoints will be assessed following the procedure through the 12 month follow-up visit.

The secondary efficacy endpoints include:

  • Proportion of subjects that achieve bilateral pulmonary vein conduction block.
  • AF burden at 6 and 12 months based on the proportion of time a subject is in AF (% of 24 hours) from the 24-hour continuous ECG monitor.
The secondary efficacy endpoints will be assessed following the procedure through the 12 month follow-up visit.
Secondary Safety Endpoint
Time Frame: The secondary safety endpoints will be assessed up to 3 years post procedure.

The proportion of subjects with acute onset post-surgical symptomatic diaphragmatic paralysis that is still present at the Month 12 follow-up visit.

The proportion of subjects reporting one or more SAEs for each follow-up interval. The intervals will include the period from:

  • the surgical procedure for the surgical TCRF ablation through the Day 30 follow-up visit;
  • the Day 30 follow-up visit through the Month 3 follow-up visit;
  • the Month 3 follow-up visit through the Month 6 follow-up visit; and
  • the Month 6 follow-up visit through the Month 12 follow-up visit. Additionally, the proportion of subjects reporting one or more SAEs annually for years 2 and 3 post procedure.
The secondary safety endpoints will be assessed up to 3 years post procedure.

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.
Endoscopic Technologies, 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: David K Swanson, Ph.D., Endoscopic Technologies, Inc

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

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.
September 1, 2012

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.
January 1, 2014

Study Completion (ANTICIPATED)

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.
May 1, 2014

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).
September 7, 2012

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.
September 7, 2012

First Posted (ESTIMATE)

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.
September 11, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

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.
April 23, 2014

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.
April 22, 2014

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.
April 1, 2014

More Information

Terms related to this study

Keywords

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.
  • 400-02
  • ATTAC-AF

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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