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Study terminated based on decision of Sponsor.
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The purpose of the study is to compare two types of treatment for atrial fibrillation (AF) that are designed to treat the symptoms of atrial fibrillation. The treatments being compared are:
To learn more about the CardioFocus ENABLE investigational clinical study, please contact the study site closest to you.
Eligibility Criteria
Persons with paroxysmal atrial fibrillation may be eligible for this study. Other study eligibility criteria include:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Single ablation procedure with Endoscopic Ablation System |
|
| 2 | Active Comparator | Medication |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Endoscopic Ablation System | Device | Single ablation procedure with Endoscopic Ablation System |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Freedom for Symptomatic Episode of Atrial Fibrillation at One Year | One Year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Vivek Reddy, MD | University of Miami | Principal Investigator |
| Andrea Natale, MD | Texas Cardiac Arrhythmia | Principal Investigator |
| Burke Barrett | CardioFocus, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arizona Arrhythmia Consultants | Scottsdale | Arizona | 85260 | United States | ||
| Mercy General Hospital |
None outside of the protocol.
The study was terminated early by the decision of the Sponsor after 64 participants were enrolled and 25 were treated.
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| ID | Title | Description |
|---|---|---|
| FG000 | Single Ablation Procedure With Endoscopic Ablation System | Single ablation procedure with Endoscopic Ablation System |
| FG001 | Standard Anti-arrhythmic Drug Therapy | Medication as prescribed by physician. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Standard Anti-arrhythmic Drug (AAD) Therapy |
| Drug |
Medication as prescribed by physician. |
|
| Sacramento |
| California |
| 95819-3633 |
| United States |
| University of California at San Francisco | San Francisco | California | 94143 | United States |
| St. John's Health Center | Santa Monica | California | United States |
| Palm Beach Heart Research Institute | Atlantis | Florida | 33462 | United States |
| Florida Hospital | Orlando | Florida | United States |
| Indiana University, Krannert Institute of Cardiology | Indianapolis | Indiana | 46202 | United States |
| Genesis Medical Center | Davenport | Iowa | United States |
| University of Michigan | Ann Arbor | Michigan | 48109 | United States |
| William Beaumont Hospital | Royal Oak | Michigan | United States |
| St. Luke's-Roosevelt | New York | New York | United States |
| Strong Memorial Hosptial - University of Rochester | Rochester | New York | 14627 | United States |
| Ohio State University | Columbus | Ohio | 43210 | United States |
| University of Pennsylvania Hospital | Philadelphia | Pennsylvania | 19096 | United States |
| Texas Cardiac Arrhythmia Research | Austin | Texas | 78705 | United States |
| The Methodist Hospital | Houston | Texas | 77030 | United States |
| University of Virginia | Charlottesville | Virginia | United States |
| Sentara Cardiovascular Research Institute | Norfolk | Virginia | 23507 | United States |
| COMPLETED |
|
| NOT COMPLETED |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Single Ablation Procedure With Endoscopic Ablation System | Single ablation procedure with Endoscopic Ablation System |
| BG001 | Standard Anti-arrhythmic Drug Therapy | Medication as prescribed by physician. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number | Participants |
| ||||||||||||||||||
| Sex/Gender, Customized | Number | Participants |
| ||||||||||||||||||
| Region of Enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Freedom for Symptomatic Episode of Atrial Fibrillation at One Year | Early study termination before one year. | Posted | Number | participants | One Year |
|
|
After treatment and during up to 1 year follow-up.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Single Ablation Procedure With Endoscopic Ablation System | Single ablation procedure with Endoscopic Ablation System | 5 | 32 | 4 | 32 | ||
| EG001 | Standard Anti-arrhythmic Drug Therapy | Medication as prescribed by physician. | 0 | 32 | 5 | 32 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Mechanical Perforation | Cardiac disorders | Non-systematic Assessment |
| ||
| Pericarditis | Cardiac disorders | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| diaphragmatic paralysis | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| chest pain | Ear and labyrinth disorders | Non-systematic Assessment |
| ||
| Medication Intolerance | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
This study was terminated early due to Sponsor decision. Therefore, full patient assignement to treatments post-randomziation did not occur. Results and other measures cannot be determined because most patients exited the study before completion.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Burke T. Barrett, Study Director | CardioFocus, Inc. | 508 658-7200 | bbarrett@cardiofocus.com |
| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D013812 | Therapeutics |
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|
| Female |
|
| Unknown |
|