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| ID | Type | Description | Link |
|---|---|---|---|
| ATTAC-AF |
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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| The Estech COBRA® Surgical System | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| The Estech COBRA® Surgical System | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | The primary efficacy endpoint will be assessed following the blanking interval through Month 12. |
| 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):
| The primary safety endpoint will be assessed within 30 days of the procedure or hospital discharge, whichever is later. |
| Measure | Description | Time Frame |
|---|---|---|
| Secondary Efficacy Endpoint | The secondary efficacy endpoints include:
| The secondary efficacy endpoints will be assessed following the procedure through the 12 month follow-up visit. |
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Inclusion Criteria:
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:
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.
Exclusion Criteria:
Subjects will be excluded from participating in this trial if they meet any of the following exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David K Swanson, Ph.D. | Endoscopic Technologies, Inc | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Banner Good Samaritan Medical Center | Mesa | Arizona | 85206 | United States | ||
| Hartford Hospital |
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| 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 secondary safety endpoints will be assessed up to 3 years post procedure. |
| Hartford |
| Connecticut |
| 06102 |
| United States |
| Saint Joseph's Hospital of Atlanta | Atlanta | Georgia | 30342 | United States |
| North Shore Univ. Health System | Evanston | Illinois | 60201 | United States |
| Advocate Christ Medical Center | Oak Lawn | Illinois | 60453 | United States |
| The Univ. of Kansas Hospital | Kansas City | Kansas | 66160 | United States |
| Univ. of Michigan Cardiovascular Center | Ann Arbor | Michigan | 48109 | United States |
| Mayo Clinic / St. Mary's Hospital | Rochester | Minnesota | 55905 | United States |
| Lenox Hill Hospital / North Shore-LIJ Health System | New York | New York | 10075 | United States |
| Mohawk Valley Heart Institute / St. Elizabeth Medical Center | Utica | New York | 13501 | United States |
| Sisters of Charity, Providence Hospital | Columbia | South Carolina | 29204 | United States |
| Fairfax Hospital, Department of Cardiovascular and Thoracic Surgery | Falls Church | Virginia | 22041 | United States |
| Aurora St. Luke's Medical Center | Milwaukee | Wisconsin | 53215 | United States |
| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| D001145 | Arrhythmias, Cardiac |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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