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Persistent Atrial FibrillationNCT01683045

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

A study testing The Estech COBRA® Surgical System in people with Persistent Atrial Fibrillation, run by Endoscopic Technologies, Inc at 13 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Persistent Atrial Fibrillation
What is being tested?
The Estech COBRA® Surgical System
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
6 participants
Where
13 sitesUnited States
Study dates
Sep 2012to May 2014
Phase
Interventional
Are there results?
None posted in the registry

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 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • All subjects are required to meet the following inclusion criteria in order to be considered eligible for participation in this trial:
  • Subject is scheduled to undergo elective on-pump cardiac surgical procedure(s) for one or more of the following:
  • Mitral valve repair or replacement,
  • Aortic valve repair or replacement,
  • Tricuspid valve repair or replacement, or
  • Coronary Artery Bypass procedures;
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  • 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;
  • Age 18 to 80 years old;
  • Left ventricular ejection fraction (LVEF) ≥ 30%;
  • Subject has no contraindications to intraoperative transesophageal echocardiography;
  • Subject has a life expectancy greater than 12 months; and
  • 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.

Who cannot join

  • Subjects will be excluded from participating in this trial if they meet any of the following exclusion criteria:
  • History of non-paroxysmal AF less than 3 months or for more than 5 years;
  • History of prior cardiac ablative surgical or catheter-based therapy;
  • Previous cardiac surgery (redo) or other intrapericardial procedures;
  • Class IV NYHA heart failure;
  • Known carotid artery stenosis greater than 80% or previous carotid endarterectomy;
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  • Wolff-Parkinson-White syndrome;
  • Need for emergent cardiac surgery (e.g., cardiogenic shock);
  • Untreated hyperthyroidism;
  • Untreated hypothyroidism;
  • Acute pulmonary disease;
  • Electrolyte imbalance;
  • History of myocarditis;
  • 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);
  • History of pericarditis;
  • Previous left phrenic nerve paralysis;
  • Bullous lung disease;
  • Presence of active endocarditis, or local or systemic infection;
  • Recent myocardial infarction (< 3 months);
  • Renal failure requiring dialysis or hepatic failure or creatinine of >2 mg/dL preoperatively;
  • Antiarrhythmic drug therapy required for the treatment of a ventricular arrhythmia;
  • Preoperative need for an intra-aortic balloon pump or intravenous inotropes;
  • Severe peripheral arterial occlusive disease defined as claudication with minimal exertion;
  • Therapy resulting in compromised tissue integrity including: thoracic radiation, chemotherapy, long term treatment with oral or injected steroids, or known connective tissue disorders;
  • Documented left atrial size of 6 cm or more;
  • History of cerebrovascular disease or accident, including stroke or transient ischemic attack (TIA) within 6 months prior to enrollment;
  • Known contraindication to anticoagulant therapy or inability to comply with anticoagulant therapy;
  • 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;
  • Forced expiratory volume in 1 second less than 30% of predicted value or need for home oxygen therapy; or
  • Surgical management of hypertrophic obstructive cardiomyopathy.

Trial locations and contacts

13 sites in 1 country.

13 sites in 1 country

United States13 sites

  • Univ. of Michigan Cardiovascular Center

    Ann Arbor, Michigan, 48109

  • Saint Joseph's Hospital of Atlanta

    Atlanta, Georgia, 30342

  • Sisters of Charity, Providence Hospital

    Columbia, South Carolina, 29204

  • North Shore Univ. Health System

    Evanston, Illinois, 60201

  • Fairfax Hospital, Department of Cardiovascular and Thoracic Surgery

    Falls Church, Virginia, 22041

  • Hartford Hospital

    Hartford, Connecticut, 06102

  • The Univ. of Kansas Hospital

    Kansas City, Kansas, 66160

  • Banner Good Samaritan Medical Center

    Mesa, Arizona, 85206

  • Aurora St. Luke's Medical Center

    Milwaukee, Wisconsin, 53215

  • Lenox Hill Hospital / North Shore-LIJ Health System

    New York, New York, 10075

  • Advocate Christ Medical Center

    Oak Lawn, Illinois, 60453

  • Mayo Clinic / St. Mary's Hospital

    Rochester, Minnesota, 55905

  • Mohawk Valley Heart Institute / St. Elizabeth Medical Center

    Utica, New York, 13501

Other trials in United States

About this study

Official title: 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.

Read the 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).

Being tested
The Estech COBRA® Surgical System
Keywords
non-paroxysmal atrial fibrillation, persistent atrial fibrillation, atrial fibrillation, heart palpitations, irregular heart beat, temperature-controlled radiofrequency ablation, radiofrequency energy, TCRF energy, RF energy, epicardial and endocardial lesions, concomitant heart surgery, surgical ablation
Medical subject headings
Atrial Fibrillation, Arrhythmias, Cardiac

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • The Estech COBRA® Surgical SystemDevice

    Also called Estech COBRA Cooled™ Surgical Probe, Estech COBRA Adhere™ XL Surgical System, Estech COBRA Adhere™ XL 2 Surgical System, Estech COBRA® Revolution Bipolar Clamp

    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.

Study groups in NCT01683045
Study groupRoleWhat they receive
The Estech COBRA® Surgical SystemExperimentalNot described
Receives: Device: The Estech COBRA® Surgical System

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Primary Efficacy Endpoint

    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.

    Measured: The primary efficacy endpoint will be assessed following the blanking interval through Month 12.

  2. Primary Safety Endpoint

    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.

    Measured: The primary safety endpoint will be assessed within 30 days of the procedure or hospital discharge, whichever is later.

Secondary outcomes (2)

  1. Secondary Efficacy Endpoint

    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.

    Measured: The secondary efficacy endpoints will be assessed following the procedure through the 12 month follow-up visit.

  2. Secondary Safety Endpoint

    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.

    Measured: The secondary safety endpoints will be assessed up to 3 years post procedure.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Sep 2012 (estimated)
  2. Study startSep 2012
  3. Primary completionJan 2014
  4. Study completionMay 2014 (estimated)

Resources

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
6 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01683045
Sponsor's protocol ID
400-02
Other IDs
ATTAC-AF
Status last verified
Apr 2014
First submitted
7 Sep 2012
Last updated
23 Apr 2014
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A study testing The Estech COBRA® Surgical System in people with Persistent Atrial Fibrillation, run by Endoscopic Technologies, Inc at 13 sites in United States.

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 13 inclusion and 30 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: stopped early, as of the sponsor's last update on 23 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 13 sites in United States. 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?

The study was stopped early. Results are not available in the source record.

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 Efficacy Endpoint (time frame: The primary efficacy endpoint will be assessed following the blanking interval through Month 12.). 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 NCT01683045.

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 23 Apr 2014.

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