Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
To demonstrate that ablation with the Therapy™ Cool Flex™ Irrigated Ablation System is effective in the treatment of typical atrial flutter (cavo-tricuspid dependent) and that its use does not result in an unacceptable risk of intra-procedural, serious cardiac adverse events.
This will be a prospective, multi-center and non-randomized study. All treated patients will receive ablation therapy for typical atrial flutter using the TherapyTM Cool FlexTM Irrigated Ablation System. Historical data from combined published (PMA P060019 Cool Path) and reported (IDE G090109 Cool Path Duo) Atrial Flutter studies will be used to determine performance goals for study endpoints.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment Arm | Experimental | Radio-frequency cardiac ablation for treatment of isthmus-dependant atrial flutter using the Therapy™ Cool Flex™ Irrigated Ablation System |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Therapy™ Cool Flex™ Irrigated Ablation System | Device | The investigational components of the Therapy™ Cool Flex™ Irrigated Ablation System consist of:
|
| Measure | Description | Time Frame |
|---|---|---|
| Primary Safety: Incidence of Composite, Serious Adverse Events Within 7 Days Post-Procedure | Primary safety is defined as the incidence of composite, serious adverse events within 7 days post-procedure, regardless of whether a determination can be made regarding device relatedness. | 7 days |
| Primary Efficacy | Primary efficacy or acute success is defined as achievement of bi-directional block in the cavo-tricuspid isthmus and non-inducibility of typical atrial flutter at least 30 minutes following the last RF ablation with the investigational system. | 30 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Secondary Efficacy | Secondary efficacy or chronic success is defined as freedom from recurrence of typical atrial flutter 3 mos. post ablation. Flutter recurrence will be documented on an ECG. Repeat ablations, new antiarrhythmia medications or increase in the existing anti-arrhythmic medications during the 3 mos. post ablation are considered chronic failures. | 3 months |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Raul Weiss, MD | Ohio State University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St. Joseph's Hospital-Heart Rhythm Specialists, PC | Phoenix | Arizona | 85013 | United States | ||
| Summit - Cardiovascular Consultants Med Group, Inc. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Treatment Arm | Therapy™ Cool Flex™ Irrigated Ablation System: The investigational components of the Therapy™ Cool Flex™ Irrigated Ablation System consist of:
|
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Oakland |
| California |
| 94609 |
| United States |
| Huntington Memorial / Foothill Cardiology | Pasadena | California | 91105 | United States |
| Regional Cardiology Associates | Sacramento | California | 95819 | United States |
| Community Memorial Hospital | Ventura | California | 93006 | United States |
| Adventist Health / Florida Hospital | Orlando | Florida | 32803 | United States |
| Tampa General Hospital | Tampa | Florida | 33606 | United States |
| St. Joseph's Hospital | Atlanta | Georgia | 30342 | United States |
| Washington Hospital Center | Georgetown | Maryland | 20010 | United States |
| Lahey Clinic Medical Center | Burlington | Massachusetts | 01835 | United States |
| Jersey Shore Universty Medical Center | Neptune City | New Jersey | 07753 | United States |
| Mount Sinai School of Medicine | New York | New York | 10029 | United States |
| Forsyth Medical Center | Winston-Salem | North Carolina | 27103 | United States |
| Ohio State University Medical Center | Columbus | Ohio | 43210 | United States |
| Cleveland Clinic / Cardiovascular Associates of Cleveland | Mayfield Heights | Ohio | 44124 | United States |
| Oklahoma Heart Institute | Tulsa | Oklahoma | 74104 | United States |
| Sacred Heart Med Center | Springfield | Oregon | 97477 | United States |
| Guthrie-Robert Packer Hospital | Sayre | Pennsylvania | 18840 | United States |
| Clinical Tex Research, LLC/DBA PharmaTex Research | Amarillo | Texas | 79106 | United States |
| Heart Hospital of Austin | Austin | Texas | 78756 | United States |
| Methodist Hospital Research Institute | Houston | Texas | 77030 | United States |
| Scott & White Memorial Hospital | Temple | Texas | 76508 | United States |
| VCAT / Royal Jubilee | Victoria | British Columbia | V8R 4R2 | Canada |
| Institut de Cardiologie de Quebec (Hopital Laval) | Québec | G1V 4G5 | Canada |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Treatment Arm | Therapy™ Cool Flex™ Irrigated Ablation System: The investigational components of the Therapy™ Cool Flex™ Irrigated Ablation System consist of:
|
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| ||||||||||||||||||||||
| Age, Categorical | Count of Participants | Participants |
| |||||||||||||||||||||||
| Sex: Female, Male | Count of Participants | 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 | Primary Safety: Incidence of Composite, Serious Adverse Events Within 7 Days Post-Procedure | Primary safety is defined as the incidence of composite, serious adverse events within 7 days post-procedure, regardless of whether a determination can be made regarding device relatedness. | 200 subjects who met Inc/Excl criteria were enrolled. 21 subjects were withdrawn prior to the use of the investigational device, thus, 179 were treated. 5 subjects had composite adverse events that were serious and occurred within 7 days of the ablation procedure. These events are part of the primary safety endpoint analysis per protocol. | Posted | Number | participants | 7 days |
|
|
| ||||||||||||||||||||||||||
| Primary | Primary Efficacy | Primary efficacy or acute success is defined as achievement of bi-directional block in the cavo-tricuspid isthmus and non-inducibility of typical atrial flutter at least 30 minutes following the last RF ablation with the investigational system. | Posted | Number | participants | 30 minutes |
|
| ||||||||||||||||||||||||||||
| Secondary | Secondary Efficacy | Secondary efficacy or chronic success is defined as freedom from recurrence of typical atrial flutter 3 mos. post ablation. Flutter recurrence will be documented on an ECG. Repeat ablations, new antiarrhythmia medications or increase in the existing anti-arrhythmic medications during the 3 mos. post ablation are considered chronic failures. | Posted | Number | participants | 3 months |
|
|
Not provided
200 subjects who met Inc/Excl criteria were enrolled. 21 subjects were withdrawn prior to the use of the investigational device, thus, 179 were treated. 5 subjects had composite adverse events that were serious and occurred within 7 days of the ablation procedure. These events are part of the primary safety endpoint analysis per protocol.
Not provided
| 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 | Therapy™ Cool Flex™ Irrigated Ablation System: The investigational components of the Therapy™ Cool Flex™ Irrigated Ablation System consist of:
| 5 | 179 | 9 | 179 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Congestive Heart Failure | Cardiac disorders |
| |||
| Arrythmia | Cardiac disorders |
| |||
| Other | General disorders | Death event |
| ||
| Stroke/Cerebrovascular Accident | Cardiac disorders |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Palpitations | Cardiac disorders |
|
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Nancy Ouch, Senior Clinical Project Manager | St. Jude Medical | 949-769-5000 | NOuch@sjm.com |
| >=65 years |
|
|
|