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The primary objective is to provide additional corroborative safety and efficacy data for the Navistar Thermocool catheter for the treatment of subjects with typical atrial flutter (AFL).
This study is a prospective, non-randomized, single-arm, multi-center condition of approval evaluation. The device is currently FDA approved for commercial distribution. Subjects with symptomatic typical atrial flutter will be considered for the condition of approval study. This study will be conducted at up to 30 centers in a minimum of 221 evaluable subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Navistar ThermoCool Catheter | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RF energy delivery for treatment of Typical Atrial flutter | Device | Navistar ThermoCool catheter |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Subjects With Complete Bidirectional Conduction Block. | Acute success is defined as the confirmation of complete bidirectional conduction block across the subeustachian (cavo-tricuspid) isthmus. The percentage of subjects with confirmed conduction block will serve as the outcome measure. | During the procedure |
| Percentage of Subjects Experiencing Cardiovascular Specific Adverse Events (CSAE) Within Seven (7) Days of the Ablation Procedure. | The cardiovascular specific adverse event (CSAE) rate is the primary safety enpoint for the study. A CSAE is an event which occurs within the first week (7 days) following use of the device and is one of the following cardiac specific adverse events: cardiac perforation, pericardial effusion, pulmonary embolus, complete heart block, stroke, acute myocardial infarction, and death. | 7 Days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Warren Jackman, M.D. | University of Oklahoma | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama, Birmingham | Birmingham | Alabama | 35294 | United States | ||
| Arizona Arrhythmia Consultants |
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First subject enrollment on June 7, 2006 Last subject enrolled August 14, 2007. Enrollment rate was 20.5 subjects per month across 21 hospitals
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| ID | Title | Description |
|---|---|---|
| FG000 | Ablation Group | Subjects to undergo ablation with the NaviStar ThermoCool catheter for the treatment of typical atrial flutter. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Scottsdale |
| Arizona |
| 85251 |
| United States |
| Good Samaritan Hospital | Los Angeles | California | 90017 | United States |
| Pacific Heart Institute | Santa Monica | California | 90404 | United States |
| University of Florida | Gainsville | Florida | 32611 | United States |
| Memorial Regional Hospital | Hollywood | Florida | 33031 | United States |
| Florida Hospital | Orlando | Florida | 32803 | United States |
| University of Chicago | Chicago | Illinois | 60637 | United States |
| The Care Group LLC, St. Vincent Hospital and Health Care Center, Inc. | Indianapolis | Indiana | 46060 | United States |
| Central Baptist Hospital | Lexington | Kentucky | 40503 | United States |
| Maine Medical Center | Portland | Maine | 04102 | United States |
| University of Maryland | Baltimore | Maryland | 21201 | United States |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
| St. John Hospital and Medical Center | Detroit | Michigan | 48236 | United States |
| Park Nicollet Institute | Minneapolis | Minnesota | 55416 | United States |
| Duke University Medical Center | Durham | North Carolina | 27710 | United States |
| University of Oklahoma, Health Sciences Center | Oklahoma City | Oklahoma | 73104 | United States |
| University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
| Medical University of South Carolina | Charleston | South Carolina | 29425 | United States |
| Texas Heart Institute | Houston | Texas | 77030 | United States |
| University of Vermont, College of Medicine | Burlington | Vermont | 05401 | United States |
| INOVA Research Center | Falls Church | Virginia | 22042 | United States |
| Virginia Commonwealth University | Richmond | Virginia | 23219 | United States |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Ablation Group | Subjects to undergo ablation with the NaviStar ThermoCool catheter for the treatment of typical atrial flutter. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| 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 | Percentage of Subjects With Complete Bidirectional Conduction Block. | Acute success is defined as the confirmation of complete bidirectional conduction block across the subeustachian (cavo-tricuspid) isthmus. The percentage of subjects with confirmed conduction block will serve as the outcome measure. | Per protocol analysis. Number differs from "Participant Flow" because only 253 subjects were considered for the efficacy cohort. | Posted | Mean | 95% Confidence Interval | percentage of participants | During the procedure |
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| Primary | Percentage of Subjects Experiencing Cardiovascular Specific Adverse Events (CSAE) Within Seven (7) Days of the Ablation Procedure. | The cardiovascular specific adverse event (CSAE) rate is the primary safety enpoint for the study. A CSAE is an event which occurs within the first week (7 days) following use of the device and is one of the following cardiac specific adverse events: cardiac perforation, pericardial effusion, pulmonary embolus, complete heart block, stroke, acute myocardial infarction, and death. | Posted | Mean | 95% Confidence Interval | percentage of participants | 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 | Ablation Group | Subjects to undergo ablation with the NaviStar ThermoCool catheter for the treatment of typical atrial flutter. | 4 | 267 | 73 | 267 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pulmonary Embolus | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Complete Heart Block | Cardiac disorders | Systematic Assessment |
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| Acute myocardial infarction | Cardiac disorders | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Adverse Events within 7 Days- Device Related | General disorders | Systematic Assessment |
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| Adverse Events within 7 Days- Possibly Device Related | General disorders | Systematic Assessment |
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| Adverse Events within 7 Days- Procedure Related | General disorders | Systematic Assessment |
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| Adverse Events within 7 Days- Possibly Procedure Related | General disorders | Systematic Assessment |
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| Adverse Events within 7 Days- Unrelated to Device or Procedure | General disorders | Systematic Assessment |
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| Adverse Events Greater than 7 Days- Device Related | General disorders | Systematic Assessment |
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| Adverse Events Greater than 7 Days- Possibly Device Related | General disorders | Systematic Assessment |
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| Adverse Events Greater than 7 Days- Procedure Related | General disorders | Systematic Assessment |
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| Adverse Events Greater than 7 Days- Possibly Procedure Related | General disorders | Systematic Assessment |
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| Adverse Events Greater than 7 Days- Unrelated to Device or Procedure | General disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Christine Liu | Biosense Webster | 9098398608 | 8608 | cliu10@its.jnj.com |
| ID | Term |
|---|---|
| D001282 | Atrial Flutter |
| D006331 | Heart Diseases |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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