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To demonstrate that the use of Contact Therapyâ„¢ Cool Pathâ„¢ ablation catheter in conjunction with the EnSite Velocity Contact Technology for the treatment of typical atrial flutter
This will be a prospective, multi-center and non-randomized study. All enrolled patients who meet the eligibility criteria will receive ablation therapy for typical atrial flutter using the Contact Therapyâ„¢ Cool Pathâ„¢ Cardiac Ablation System. Historical data from published (PMA P060019 Cool Path) , reported (IDE G090109 Cool Path Duo) and published literature on Atrial Flutter RF ablation studies is used to determine performance goals for primary study endpoints and derive the sample size. In addition, the following analyses will be performed in the study
Validation of ECI against conventional methods of assessing tip tissue contact and
Ancillary analysis to assess the relationship between the ECI and study outcomes. Subjects will undergo two follow up visits at day 10 and month 3 post procedure. The following assessments will be performed during these visits:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment Arm | Experimental | Atrial Flutter RF Ablation treatment with the Contact Therapy Cool Path ablation catheter, 1500 T9 V1.43 RF Generator, Model 1611 connection cable, EnSite Velocity Contactâ„¢ Kit, and EnSite Velocity Contact software controlled via entitlement. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Treatment Arm | Device | The investigational parts of the system consists of Contact Therapy Cool Path ablation catheter, 1500 T9 V1.43 RF Generator, Model 1611 connection cable, EnSite Velocity Contactâ„¢ Kit, and EnSite Velocity Contact software controlled via entitlement . |
| 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 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 investigational system. | 30 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Secondary Efficacy | Secondary efficacy / Chronic success is defined as freedom from recurrence of typical atrial flutter 3 months post ablation. Flutter recurrence will be documented on an ECG (or similar such as Holter, telemetry, rhythm strips, etc.). Repeat ablations, new antiarrhythmia medication (Class Ia, Ic, or III) or increase in the dosage of existing anti-arrhythmic medication (Class 1a, 1c, III) during the 3 months post ablation are considered chronic failures. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Larry Chinitz, MD | NYU Langone Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cardiology, P.C. | Birmingham | Alabama | 35211 | United States | ||
| Aurora Denver Cardiology |
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| ID | Title | Description |
|---|---|---|
| FG000 | Treatment Arm | Contact Therapy Cool Path ablation system in conjunction with EnSite Velocity Contact system : The investigational parts of the system consists of Contact Therapy Cool Path ablation catheter, 1500 T9 V1.43 RF Generator, Model 1611 connection cable, EnSite Velocity Contactâ„¢ Kit, and EnSite Velocity Contact software controlled via entitlement . |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| 3 months |
| Denver |
| Colorado |
| 80012 |
| United States |
| Hartford Hospital | Hartford | Connecticut | 06102 | United States |
| St. Vincent's Hospital | Jacksonville | Florida | 32204 | United States |
| Emory University Hospital | Atlanta | Georgia | 30322 | United States |
| University of Chicago | Chicago | Illinois | 60637 | United States |
| Ochsner Medical Center | New Orleans | Louisiana | 70121 | United States |
| New York University Langone Medical Center - Tisch Hospital | New York | New York | 10016 | United States |
| University of Rochester | Rochester | New York | 14642 | United States |
| University of North Carolina at Chapel Hill | Chapel Hill | North Carolina | 27599 | United States |
| Presbyterian Hospital | Charlotte | North Carolina | 28204 | United States |
| Ohio Health Research Institute - GMC | Columbus | Ohio | 43215 | United States |
| Providence St. Vincent Medical Center | Portland | Oregon | 97225 | United States |
| Doylestown Hospital | Doylestown | Pennsylvania | 18901 | United States |
| Texas Health Research & Education Institute | Dallas | Texas | 75231 | United States |
| Memorial Hermann Hospital | Houston | Texas | 77030 | United States |
| St. Luke's Episcopal Hospital | Houston | Texas | 77030 | United States |
| Scott & White Memorial Hospital | Temple | Texas | 76508 | United States |
| Virginia Cardiovascular Specialists | Richmond | Virginia | 23229 | United States |
| Institut de Cardiologie de Montreal (Montreal Heart Inst.) | Montreal | Quebec | H1T 1C8 | Canada |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Treatment Arm | Contact Therapy Cool Path ablation system in conjunction with EnSite Velocity Contact system : The investigational parts of the system consists of Contact Therapy Cool Path ablation catheter, 1500 T9 V1.43 RF Generator, Model 1611 connection cable, EnSite Velocity Contactâ„¢ Kit, and EnSite Velocity Contact software controlled via entitlement . |
| 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 | 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. | 150 subjects who met Inc/Excl criteria were enrolled. 16 subjects were withdrawn prior to the use of the investigational device, thus,134 were treated. 3 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 |
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| Primary | Primary Efficacy | Primary efficacy or Acute success is defined as achievement of 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 investigational system. | 134 subjects were treated with the investigational catheter and system with 1 subject failing to pass the bidirectional block inducibility test 30 minutes post ablation. Thus 133 subjects comprised the primary efficacy cohort. | Posted | Number | participants | 30 minutes |
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| Secondary | Secondary Efficacy | Secondary efficacy / Chronic success is defined as freedom from recurrence of typical atrial flutter 3 months post ablation. Flutter recurrence will be documented on an ECG (or similar such as Holter, telemetry, rhythm strips, etc.). Repeat ablations, new antiarrhythmia medication (Class Ia, Ic, or III) or increase in the dosage of existing anti-arrhythmic medication (Class 1a, 1c, III) during the 3 months post ablation are considered chronic failures. | 134 subjects were treated with the investigational catheter and system with 10 subjects experiencing recurring AFL. Thus 124 subjects comprised the secondary efficacy cohort (freedom from AFL at 90 days). | Posted | Number | participants | 3 months |
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150 subjects who met Inc./Excl. criteria were enrolled. 16 subjects were withdrawn prior to the use of the investigational device, thus,134 received the device. 3 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.
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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 | Contact Therapy Cool Path ablation system in conjunction with EnSite Velocity Contact system : The investigational parts of the system consists of Contact Therapy Cool Path ablation catheter, 1500 T9 V1.43 RF Generator, Model 1611 connection cable, EnSite Velocity Contactâ„¢ Kit, and EnSite Velocity Contact software controlled via entitlement . | 3 | 134 | 10 | 134 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Congestive Heart Failure | Cardiac disorders | Systematic Assessment |
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| Intermittent High Grade AV Block | Cardiac disorders | Systematic Assessment |
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| Transient Ischemic Attack | Nervous system disorders | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Arrhythmia | Cardiac disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Nancy Ouch | St. Jude Medical | +19497695041 | NOuch@sjm.com |
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