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This is a prospective, multicenter, non-randomized observational study of subjects 18 years and older undergoing RF ablation with drug refractory recurrent symptomatic paroxysmal Atrial Fibrillation (AF).
This study is purposed to measure "real world" acute procedural outcomes (procedural efficiency and acute safety) associated with use of the CARTO® 3 System and real time intracardiac ultrasound in a clinical setting in subjects with drug refractory recurrent symptomatic paroxysmal AF.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental: Catheter Ablation | These patients have drug refractory recurrent symptomatic paroxysmal AF, are 18 years and older, and are able and willing to provide written informed consent to participate in the study and comply with study requirements. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Catheter Ablation | Device | NAVISTAR® THERMOCOOL® SF Catheter with the CARTO® 3 System and the SOUNDSTAR® Ultrasound Catheter (with the CARTOSOUND® Software Module) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Total Fluoroscopy Time | The fluoroscopy time will be measured for each phase (access, mapping, ablation, and validation) of the procedure and summed to derive the total. | Day 0 |
| Measure | Description | Time Frame |
|---|---|---|
| Total Procedure Time | The procedure time will be measured for each phase (access, mapping, ablation, and validation) of the procedure and summed to derive the total. | Day 0 |
| Acute Procedural Success |
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Inclusion Criteria:
Exclusion Criteria:
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Subjects 18 years and older with drug refractory recurrent symptomatic paroxysmal AF
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| Name | Affiliation | Role |
|---|---|---|
| Usman Siddiqui, MD | Osceola Regional Medical Center | Principal Investigator |
| Mathew Hutchinson, MD | University of Pennsylvania | Principal Investigator |
| Andy Tran, MD | Scottsdale Healthcare Research | Principal Investigator |
| Saumil Oza, MD | East Coast Institute for Research LLC, St. Vincent's Ambulatory Care, Inc. | Principal Investigator |
| Robert Fishel, MD | JFK Medical Center | Principal Investigator |
| Vijendra Swarup, MD | AZ Heart Rhythm Research Center | Principal Investigator |
| Mohit Rastogi, MD | Washington Adventist Hospital CCVR | Principal Investigator |
| Brett Gidney, MD | Santa Barbara Cottage Hospital | Principal Investigator |
| John Scherschel, MD | University of Nebraska | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AZ Heart Rhythm Research Center | Phoenix | Arizona | 85013 | United States | ||
| Scottsdale Healthcare Research Institute |
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| ID | Title | Description |
|---|---|---|
| FG000 | Experimental: Catheter Ablation | These patients have drug refractory recurrent symptomatic paroxysmal AF, are 18 years and older, and are able and willing to provide written informed consent to participate in the study and comply with study requirements. Catheter Ablation: NAVISTAR® THERMOCOOL® SF Catheter with the CARTO® 3 System and the SOUNDSTAR® Ultrasound Catheter (with the CARTOSOUND® Software Module) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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Acute success will be defined as confirmation of pulmonary vein isolation by entrance block, exit block, and/or periostial block of all targeted pulmonary veins.
| Day 0 |
| Mean Number of Radiofrequency (RF) Applications | RF application is defined as the number of times RF energy is delivered during the procedure. | Day 0 |
| Total Radiofrequency (RF) Time | Total RF time is defined as the total time RF is delivered during the procedure. | Day 0 |
| Dilip Mathew, MD |
| Pepin Heart Hospital |
| Principal Investigator |
| William Sauer, MD | University of Colorado, Denver | Principal Investigator |
| Marcie Berger, MD | Medical College of Wisconsin | Principal Investigator |
| Khawaja Baig, MD | Kettering Medical Center | Principal Investigator |
| Farhat Khairallah, MD | Tallahassee Research Institute | Principal Investigator |
| David Fitzgerald, MD | Scott & White Memorial Hospital | Principal Investigator |
| Gopi Dandamudi, MD | Geisinger Heart Institute | Principal Investigator |
| Ahmad Abdul-Karim, MD | Provena St. Joseph Medical Center | Principal Investigator |
| Douglas Esberg, MD | Main Line Health | Principal Investigator |
| Scott Burke, MD | St. Mary's Medical Center | Principal Investigator |
| Gregory Jones, MD | Wellmont CVA Heart Institute | Principal Investigator |
| Tapan Rami, MD | The Methodist Hospital Research Institute | Principal Investigator |
| Salem Sayar, MD | Northeast Georgia Heart Center, PC | Principal Investigator |
| Gunjan Shukla, MD | Hackensack Meridian Health | Principal Investigator |
| Philip Gentlesk, MD | Sentara Norfolk General Hospital | Principal Investigator |
| Asim Yunus, MD | Michigan CardioVascular Institute | Principal Investigator |
| Scott Reich, MD | Northeast Baptist Hospital | Principal Investigator |
| Scottsdale |
| Arizona |
| 85260 |
| United States |
| Santa Barbara Cottage Hospital | Santa Barbara | California | 93105 | United States |
| University of Colorado Denver | Aurora | Colorado | 80045 | United States |
| JFK Medical Center | Atlantis | Florida | 33462 | United States |
| East Coast Institute for Research, LLC. St. Vincent's Ambulatory Care, Inc. | Jacksonville | Florida | 33204 | United States |
| Osceola Regional Medical Center | Kissimmee | Florida | 34741 | United States |
| Tallahassee Research Institute | Tallahassee | Florida | 32308 | United States |
| Pepin Heart Hospital | Tampa | Florida | 33613 | United States |
| Northeast Georgia Heart Center, PC | Gainsville | Georgia | 30501 | United States |
| Provena St. Joseph Medical Center | Joliet | Illinois | 60435 | United States |
| Washington Adventist Hospital CCVR | Takoma Park | Maryland | 20912 | United States |
| Michigan CardioVascular Institute | Saginaw | Michigan | 48601 | United States |
| University of Nebraska Medical Center | Omaha | Nebraska | 68198 | United States |
| Hackensack University Medical Center | Hackensack | New Jersey | 07601 | United States |
| Kettering Medical Center | Kettering | Ohio | 45429 | United States |
| St. Mary Medical Center | Newtown | Pennsylvania | 18940 | United States |
| Hospital of the University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
| Geisinger Heart Institute | Wilkes-Barre | Pennsylvania | 18711 | United States |
| Lankenau Institute for Medical Research | Wynnewood | Pennsylvania | 19096 | United States |
| Wellmont CVA Heart Institute | Kingsport | Tennessee | 37660 | United States |
| The Methodist Hospital Research Institute | Houston | Texas | 77030 | United States |
| Northeast Baptist Hospital | San Antonio | Texas | 78217 | United States |
| Scott & White Memorial Hospital | Temple | Texas | 76508 | United States |
| Sentara Norfolk General Hospital | Norfolk | Virginia | 23507 | United States |
| Medical College of Wisconsin | Milwaukee | Wisconsin | 53226 | United States |
| Safety |
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| COMPLETED |
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| NOT COMPLETED |
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Enrolled
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| ID | Title | Description |
|---|---|---|
| BG000 | Experimental: Catheter Ablation | These patients have drug refractory recurrent symptomatic paroxysmal AF, are 18 years and older, and are able and willing to provide written informed consent to participate in the study and comply with study requirements. Catheter Ablation: NAVISTAR® THERMOCOOL® SF Catheter with the CARTO® 3 System and the SOUNDSTAR® Ultrasound Catheter (with the CARTOSOUND® Software Module) |
| 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 |
| |||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | 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 | Total Fluoroscopy Time | The fluoroscopy time will be measured for each phase (access, mapping, ablation, and validation) of the procedure and summed to derive the total. | Those patients with non-missing fluoroscopy time. | Posted | Mean | Standard Deviation | minutes | Day 0 |
|
|
| |||||||||||||||||||||||||
| Secondary | Total Procedure Time | The procedure time will be measured for each phase (access, mapping, ablation, and validation) of the procedure and summed to derive the total. | The number of patients with non-missing procedure time data. | Posted | Mean | Standard Deviation | minutes | Day 0 |
|
| ||||||||||||||||||||||||||
| Secondary | Acute Procedural Success | Acute success will be defined as confirmation of pulmonary vein isolation by entrance block, exit block, and/or periostial block of all targeted pulmonary veins. | Acute effectiveness and efficiency cohort | Posted | Number | participants | Day 0 |
|
| |||||||||||||||||||||||||||
| Secondary | Mean Number of Radiofrequency (RF) Applications | RF application is defined as the number of times RF energy is delivered during the procedure. | Patients with non-missing RF application values | Posted | Mean | Standard Deviation | number of applications | Day 0 |
|
| ||||||||||||||||||||||||||
| Secondary | Total Radiofrequency (RF) Time | Total RF time is defined as the total time RF is delivered during the procedure. | Patients with non-missing RF application time. | Posted | Mean | Standard Deviation | minutes | Day 0 |
|
|
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 | Experimental: Catheter Ablation | These patients have drug refractory recurrent symptomatic paroxysmal AF, are 18 years and older, and are able and willing to provide written informed consent to participate in the study and comply with study requirements. Catheter Ablation: NAVISTAR® THERMOCOOL® SF Catheter with the CARTO® 3 System and the SOUNDSTAR® Ultrasound Catheter (with the CARTOSOUND® Software Module) | 22 | 230 | 13 | 230 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| atrial fibrillation | Cardiac disorders | Systematic Assessment |
| ||
| atrial flutter | Cardiac disorders | Systematic Assessment |
| ||
| atrioventricular block | Cardiac disorders | Systematic Assessment |
| ||
| cardiac failure congestive | Cardiac disorders | Systematic Assessment |
| ||
| pericardial effusion/tamponade | Cardiac disorders | Systematic Assessment |
| ||
| pericarditis | Cardiac disorders | Systematic Assessment |
| ||
| vertigo positional | Ear and labyrinth disorders | Systematic Assessment |
| ||
| chest pain | General disorders | Systematic Assessment |
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| puncture site hemorrhage | General disorders | Systematic Assessment |
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| pneumonia | Infections and infestations | Systematic Assessment |
| ||
| post procedural hematoma | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| vascular pseudoaneurysm | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| cardiac telemetry abnormal | Investigations | Systematic Assessment |
| ||
| fluid overload | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| migraine | Nervous system disorders | Systematic Assessment |
| ||
| bronchospasm | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| hypoxia | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| pulmonary edema | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| atrial fibrillation | Cardiac disorders | Systematic Assessment |
| ||
| pericarditis | Cardiac disorders | Systematic Assessment |
| ||
| pyrexia | General disorders | Systematic Assessment |
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There IS an agreement between the Principal Investigator (PI)/Institution and the Sponsor (or its agents) that restricts the PI's rights to discuss, present, or publish trial results after the trial is completed. Please contact Biosense Webster for additional information.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ellen Harris, Project Manager, Clinical Operations | Biosense Webster | 909-839-7376 | eharris8@its.jnj.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 |
|---|---|
| D017115 | Catheter Ablation |
| ID | Term |
|---|---|
| D000078703 | Radiofrequency Ablation |
| D000078702 | Radiofrequency Therapy |
| D013812 | Therapeutics |
| D055011 | Ablation Techniques |
| D013514 | Surgical Procedures, Operative |
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| Unknown or Not Reported |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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