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The purpose of this study is to demonstrate that ablation with the Therapy™ Cool Path™ Duo cardiac ablation system can eliminate typical atrial flutter and that its use does not result in an unacceptable risk of serious adverse events (SAE's).
This is a prospective, multi-center, non-randomized study (historical data as control) for the evaluating the safety and efficacy of Therapy TM Cool PathTM
Duo Ablation System for the treatment of typical atrial flutter (Cavo-triscupid isthmus dependent)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment arm | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Therapy Cool Path Duo | Device | All patients will be treated with Therapy Cool Path Duo Ablation System for the treatment of typical atrial flutter. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Primary Safety- Incidence of Intra Procedural Serious Cardiac Adverse Events Occuring Within 7 Days of Post-procedure, Regardless of Whether a Determination Can be Made Regarding Device Relatedness. | 7 days | |
| Primary Efficacy- Bidirectional Block in the Cavo-tricuspid Isthmus and Non-inducibility of Typical Atrial Flutter at Least 30 Minutes Following the Last RF Ablation With the Cool Path Duo Ablation Catheter System is Obtained. | 30 mins |
| Measure | Description | Time Frame |
|---|---|---|
| Secondary Efficacy- Freedom From Recurrence of Typical Atrial Flutter up to 3 Months Post Procedure | 3 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Regional Cardiology Associates | Sacramento | California | 95819 | United States | ||
| Kansas University Medical Center |
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| ID | Title | Description |
|---|---|---|
| FG000 | Treatment Arm |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Kansas City |
| Kansas |
| 66160 |
| United States |
| Central Baptist Hospital | Lexington | Kentucky | 40503 | United States |
| Ochsner Medical Center | New Orleans | Louisiana | 70121 | United States |
| Washington Adventist Hospital | Takoma Park | Maryland | 20912 | United States |
| Lahey Clinic Medical Center | Burlington | Massachusetts | 01805 | United States |
| University of Rochester | Rochester | New York | 14642 | United States |
| Carolinas Medical Center | Charlotte | North Carolina | 28203 | United States |
| Moses Cone Hospital | Greensboro | North Carolina | 27401 | United States |
| Ohio State Medical | Columbus | Ohio | 43210 | United States |
| Cardiovascular Associates of Cleveland | Mayfield Heights | Ohio | 44124 | United States |
| Providence St. Vincent Medical Center | Portland | Oregon | 97225 | United States |
| Doylestown Hospital | Doylestown | Pennsylvania | 18901 | United States |
| Main Line Health Center/Lankenau | Wynnewood | Pennsylvania | 19096 | United States |
| Baylor Jack and Jane Hamilton Heart and Vascular Hospital | Dallas | Texas | 75226 | United States |
| St. Luke's Episcopal Hospital | Houston | Texas | 77030 | United States |
| The Methodist Hospital | Houston | Texas | 77030 | United States |
| Scott & White Memorial Hospital | Temple | Texas | 76508 | United States |
| Virginia Hospital Center | Arlington | Virginia | 22205 | United States |
| University of Virginia Medical Center | Charlottesville | Virginia | 22908 | United States |
| Victoria Cardiac Arrhythmia Trials, Inc. | Victoria | British Columbia | V8R 4R2 | Canada |
| Institut de Cardiologie de Quebec | Québec | G1V 4G5 | Canada |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Treatment Arm |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| |||||||||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| 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 | Primary Safety- Incidence of Intra Procedural Serious Cardiac Adverse Events Occuring Within 7 Days of Post-procedure, Regardless of Whether a Determination Can be Made Regarding Device Relatedness. | Posted | Number | participants | 7 days |
|
|
| ||||||||||||||||||||||||||||
| Primary | Primary Efficacy- Bidirectional Block in the Cavo-tricuspid Isthmus and Non-inducibility of Typical Atrial Flutter at Least 30 Minutes Following the Last RF Ablation With the Cool Path Duo Ablation Catheter System is Obtained. | Posted | Number | participants | 30 mins |
|
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| ||||||||||||||||||||||||||||
| Secondary | Secondary Efficacy- Freedom From Recurrence of Typical Atrial Flutter up to 3 Months Post Procedure | Posted | Number | participants | 3 months |
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|
Composite SAEs within 7 days
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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 | Treatment Arm | 12 | 188 | 23 | 188 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiac Arrhythmia | Cardiac disorders | Systematic Assessment |
| ||
| Congestive Heart Failure | Cardiac disorders | Systematic Assessment |
| ||
| Syncope | Nervous system disorders | Non-systematic Assessment |
| ||
| Pericarditis | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Coronary Artery Disease | Vascular disorders | Systematic Assessment |
| ||
| Atrial Fibrillation | Cardiac disorders | Non-systematic Assessment |
| ||
| Hypotension | Vascular disorders | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiac Arrhthymia | Cardiac disorders | Systematic Assessment |
| ||
| Palpitations | Cardiac disorders | Non-systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Nabil Kanaan | St. Jude Medical | 949-769-5000 | nkanaan@sjm.com |
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| Title | Measurements |
|---|---|
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