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
Not provided
This is a prospective, interventional, observational, unblinded, single-arm, multicenter registry of younger and older subjects with drug refractory, recurrent, symptomatic paroxysmal atrial fibrillation.
This study is to measure the "real-world" acute procedural outcomes (procedural efficiency, acute safety, and effectiveness at one year) associated with use of the NAVISTAR® THERMOCOOL® SF Catheter in a clinical setting in subjects with drug refractory, recurrent symptomatic paroxysmal atrial fibrillation.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Catheter Ablation | These patients have drug refractory, recurrent, symptomatic paroxysmal atrial fibrillation, are aged 18 years or older, and have provided written informed consent to participate in the study, including consent to undergo catheter ablation with the study device. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Catheter Ablation (NAVISTAR® THERMOCOOL® SF Catheter) | Device | Administer anesthesia according to standard EP lab protocol, assess the fluid status of the subject (after each liter of infusate), determine if diuresis is necessary, and treat accordingly. |
| 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 time. | Day 0 (procedure) |
| Total Procedure Time | Day 0 (procedure) | |
| Acute Procedural Success | Confirmation of entrance and/or exit block across all targeted pulmonary veins. | Day 0 (procedure) |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Number of Radiofrequency (RF) Applications | RF applications is defined as the number of times RF energy is delivered during the procedure. | Day 0 (procedure) |
| Total Radiofrequency (RF) Time |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Older and younger patients with drug refractory, symptomatic paroxysmal atrial fibrillation.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Gery Tomassoni, MD | Central Baptist Hospital | Principal Investigator |
| Scott Pollak, MD | Florida Hospital - Orlando | Principal Investigator |
| Andy Tran, MD | Scottsdale Healthcare Research Institute | Principal Investigator |
| Saumil Oza, MD | St. Vincent's Ambulatory Care, Inc. | Principal Investigator |
| Steven Compton, MD | Alaska Heart Institute, LLC | Principal Investigator |
| Anshul Patel, MD | St. Joseph's Hospital of Atlanta | Principal Investigator |
| Robert Fishel, MD | JFK Medical Center | Principal Investigator |
| Kenneth Civello, MD | Cardiovascular Research Foundation of Louisiana | Principal Investigator |
| Gaurang Gandhi, MD | Bethesda North Hospital | Principal Investigator |
| Alexandru Costea, MD |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Heart Center Research, LLC | Huntsville | Alabama | 35801 | United States | ||
| Alaska Heart Institute, LLC |
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Catheter Ablation | These patients have drug refractory, recurrent, symptomatic paroxysmal atrial fibrillation, are aged 18 years or older, and are able and willing to provide written informed consent to participate in the study. Catheter Ablation (NAVISTAR® THERMOCOOL® SF Catheter): Administer anesthesia according to standard EP lab protocol, assess the fluid status of the subject (after each liter of infusate), determine if diuresis is necessary, and treat accordingly. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Total RF time is defined as the total time that RF energy is delivered during the procedure.
| Day 0 (procedure) |
| Fluid Volume Delivered Via Ablation Catheter | Day 0 (procedure) |
| Number of Patients With Repeat Ablations | 1 year |
| Post-procedure AF Symptoms | Symptoms attributed to paroxysmal atrial fibrillation reported at 12 month visit | 12 Month Visit |
| Number of Subjects With Lost Work Days, Related to AF, at 12 Month Visit | 12 Month Visit |
| Number of Patients With Inpatient Hospital Visit(s) Related to Atrial Fibrillation | 12 Month Visit |
| Number of Patients With Outpatient Emergency Visits Related to Atrial Fibrillation | 12 Month Visit |
| Change in Atrial Fibrillation Effect on Quality of Life (AFEQT) Total Score | Change is calculated as 12 month overall AFEQT score minus score at screening. An overall AFEQT score ranges from 0 to 100. A score of 0 corresponds to complete disability (or responding "extremely" limited, difficult or bothersome to all questions answered), while a score of 100 corresponds to no disability (or responding "not at all" limited, difficult or bothersome to all questions answered). Therefore a positive change in score corresponds to improvement in AF symptoms. | Screening to 12 Month Visit |
| University of Cincinnati |
| Principal Investigator |
| Sreedhar Billakanty, MD | Riverside Methodist Hospital | Principal Investigator |
| H. James Wang, MD | Florida Hospital Memorial Medical Center | Principal Investigator |
| John Harding, MD | Central Bucks Specialists, Ltd. | Principal Investigator |
| Mohammed Khan, MD | Alexian Brothers Medical Center | Principal Investigator |
| Vijay Jayachandran, MD | Baylor All Saints Medical Center | Principal Investigator |
| Sree Karanam, MD | Lutheran Medical Group, LLC | Principal Investigator |
| M. Craig Delaughter, MD | Plaza Medical Center | Principal Investigator |
| Mohammad Jazayeri, MD | Bellin Memorial Hospital, Inc. | Principal Investigator |
| Abdi Rasekh, MD | Texas Heart Institute at St. Luke's Episcopal Hospital | Principal Investigator |
| Scott Allison, MD | Heart Center Research, LLC | Principal Investigator |
| Alexander Mazur, MD | University of Iowa Hospital & Clinics | Principal Investigator |
| Dhanunjaya Lakkireddy, MD | University of Kansas Hospitals | Principal Investigator |
| Alan Wimmer, MD | St. Luke's Hospital Mid American Heart Institute | Principal Investigator |
| Ali Hamzei, MD | Scripps Clinical Research | Principal Investigator |
| Shalin Shah, MD | Largo Medical Center | Principal Investigator |
| Michael Kutayli, MD | Bryan LGH Heart Institute | Principal Investigator |
| John Mandrola, MD | Baptist Hospital | Principal Investigator |
| Stuart Beldner, MD | North Shore University Hospital | Principal Investigator |
| Joshua Moss, MD | University of Chicago | Principal Investigator |
| Greg Bashian, MD | Centennial Heart | Principal Investigator |
| Patrick Whalen, MD | Vanderbilt Heart and Vascular Institute | Principal Investigator |
| Angelo Biviano, MD | New York Presbyterian Hospital, Columbia University Medical Center | Principal Investigator |
| Hussam Abuissa, MD | The Cardiac Center of Creighton University | Principal Investigator |
| Sumeet Mainigi, MD | Albert Einstein Medical Center | Principal Investigator |
| Charles Athill, MD | San Diego Cardiac Center | Principal Investigator |
| Edward Gerstenfeld, MD | UCSF Medical Center | Principal Investigator |
| Michael Chisner, MD | Cardiology Associates of Savannah | Principal Investigator |
| Vijendra Swarup, MD | Arizona Heart Hospital | Principal Investigator |
| Ziad Issa, MD | Prairie Education and Research Cooperative | Principal Investigator |
| Tariq Salam, MD | Cardiac Study Center | Principal Investigator |
| Sung Lee, MD | Washington Adventist Hospital | Principal Investigator |
| M. Magdy Migeed, MD | Genesis Healthcare Systems | Principal Investigator |
| Jonathan Sussman, MD | Morristown Medical Center | Principal Investigator |
| Bengt Herweg, MD | Tampa General Hospital | Principal Investigator |
| Pierce Vatterott, MD | United Heart and Vascular Clinic | Principal Investigator |
| Anchorage |
| Alaska |
| 99508 |
| United States |
| Arizona Heart Hospital | Phoenix | Arizona | 85006 | United States |
| Scottsdale Healthcare Research Institute | Scottsdale | Arizona | 85258 | United States |
| Scripps Clinical Research | La Jolla | California | 92037 | United States |
| San Diego Cardiac Center | San Diego | California | 92123 | United States |
| UCSF Medical Center | San Francisco | California | 94143 | United States |
| JFK Medical Center | Atlantis | Florida | 33462 | United States |
| Florida Hospital Memorial Medical Center | Daytona Beach | Florida | 32117 | United States |
| St. Vincent's Ambulatory Care, Inc. | Jacksonville | Florida | 32204 | United States |
| Largo Medical Center | Largo | Florida | 33774 | United States |
| Florida Hospital - Orlando | Orlando | Florida | 32803 | United States |
| Tampa General Hospital | Tampa | Florida | 33606 | United States |
| St. Joseph's Hospital of Atlanta | Atlanta | Georgia | 30342 | United States |
| Cardiology Associates of Savannah | Savannah | Georgia | 31419 | United States |
| University of Chicago Medical Center | Chicago | Illinois | 60637 | United States |
| Alexian Brothers Medical Center | Elk Grove Village | Illinois | 60007 | United States |
| Prairie Education and Research Cooperative | Springfield | Illinois | 62701 | United States |
| Lutheran Medical Group, LLC | Fort Wayne | Indiana | 46804 | United States |
| University of Iowa Hospital & Clinics | Iowa City | Iowa | 55242 | United States |
| University of Kansas Hospitals | Kansas City | Kansas | 66160 | United States |
| Central Baptist Hospital | Lexington | Kentucky | 40503 | United States |
| Baptist Hospital | Louisville | Kentucky | 40207 | United States |
| Cardiovascular Research Foundation of Louisiana | Baton Rouge | Louisiana | 70808 | United States |
| Washington Adventist Hospital | Takoma Park | Maryland | 20912 | United States |
| United Heart and Vascular Clinic | Saint Paul | Minnesota | 55102 | United States |
| St. Luke's Mid American Heart Institute | Kansas City | Missouri | 64111 | United States |
| Bryan LGH Heart Institute | Lincoln | Nebraska | 68506 | United States |
| The Cardiac Center of Creighton University | Omaha | Nebraska | 68131 | United States |
| Morristown Medical Center | Morristown | New Jersey | 07960 | United States |
| North Shore University Hospital | Manhasset | New York | 11030 | United States |
| New York Presbyterian Hospital, Columbia University Medical Center | New York | New York | 10032 | United States |
| Bethesda North Hospital | Cincinnati | Ohio | 45242 | United States |
| University of Cincinnati | Cincinnati | Ohio | 45267 | United States |
| Riverside Methodist Hospital | Columbus | Ohio | 43214 | United States |
| Genesis Healthcare Systems | Zanesville | Ohio | 43701 | United States |
| Central Bucks Specialists, LTD | Doylestown | Pennsylvania | 18901 | United States |
| Albert Einstein Medical Center | Philadelphia | Pennsylvania | 19141 | United States |
| Centennial Heart | Nashville | Tennessee | 37203 | United States |
| Vanderbilt Heart and Vascular Institute | Nashville | Tennessee | 37232-8802 | United States |
| Baylor All Saints Medical Center | Fort Worth | Texas | 76104 | United States |
| Plaza Medical Center | Grapevine | Texas | 76501 | United States |
| Texas Heart Institute at St. Luke's Episcopal Hospital | Houston | Texas | 77030 | United States |
| Cardiac Study Center | Tacoma | Washington | 98405 | United States |
| Bellin Memorial Hospital, Inc. | Green Bay | Wisconsin | 54301 | United States |
| Safety |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
Enrolled patients
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Catheter Ablation | These patients have drug refractory, recurrent, symptomatic paroxysmal atrial fibrillation, are aged 18 years or older, and are able and willing to provide written informed consent to participate in the study. Catheter Ablation (NAVISTAR® THERMOCOOL® SF Catheter): Administer anesthesia according to standard EP lab protocol, assess the fluid status of the subject (after each liter of infusate), determine if diuresis is necessary, and treat accordingly. |
| 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 |
| ||||||||||||||||||||
| 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 | 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 time. | Subset of Safety Population with non-missing endpoint data. | Posted | Mean | Standard Deviation | minutes | Day 0 (procedure) |
|
|
| |||||||||||||||||||||||||
| Primary | Total Procedure Time | Subset of Safety Population with non-missing endpoint data. | Posted | Mean | Standard Deviation | minutes | Day 0 (procedure) |
|
| |||||||||||||||||||||||||||
| Primary | Acute Procedural Success | Confirmation of entrance and/or exit block across all targeted pulmonary veins. | Safety population | Posted | Number | participants | Day 0 (procedure) |
|
| |||||||||||||||||||||||||||
| Secondary | Mean Number of Radiofrequency (RF) Applications | RF applications is defined as the number of times RF energy is delivered during the procedure. | Subset of Safety Population with non-missing endpoint data. | Posted | Mean | Standard Deviation | number of applications | Day 0 (procedure) |
|
| ||||||||||||||||||||||||||
| Secondary | Total Radiofrequency (RF) Time | Total RF time is defined as the total time that RF energy is delivered during the procedure. | Subset of Safety Population with non-missing endpoint data. | Posted | Mean | Standard Deviation | minutes | Day 0 (procedure) |
|
| ||||||||||||||||||||||||||
| Secondary | Fluid Volume Delivered Via Ablation Catheter | Subset of Safety Population with non-missing endpoint data. | Posted | Mean | Standard Deviation | mL | Day 0 (procedure) |
|
| |||||||||||||||||||||||||||
| Secondary | Number of Patients With Repeat Ablations | Safety Population | Posted | Number | participants | 1 year |
|
| ||||||||||||||||||||||||||||
| Secondary | Post-procedure AF Symptoms | Symptoms attributed to paroxysmal atrial fibrillation reported at 12 month visit | Subset of Safety Population with non-missing endpoint data. | Posted | Number | participants | 12 Month Visit |
|
| |||||||||||||||||||||||||||
| Secondary | Number of Subjects With Lost Work Days, Related to AF, at 12 Month Visit | Subset of Safety Population with non-missing endpoint data. | Posted | Number | participants | 12 Month Visit |
|
| ||||||||||||||||||||||||||||
| Secondary | Number of Patients With Inpatient Hospital Visit(s) Related to Atrial Fibrillation | Population with Utilization Data | Posted | Number | participants | 12 Month Visit |
|
| ||||||||||||||||||||||||||||
| Secondary | Number of Patients With Outpatient Emergency Visits Related to Atrial Fibrillation | Population with Utilization Data | Posted | Number | participants | 12 Month Visit |
|
| ||||||||||||||||||||||||||||
| Secondary | Change in Atrial Fibrillation Effect on Quality of Life (AFEQT) Total Score | Change is calculated as 12 month overall AFEQT score minus score at screening. An overall AFEQT score ranges from 0 to 100. A score of 0 corresponds to complete disability (or responding "extremely" limited, difficult or bothersome to all questions answered), while a score of 100 corresponds to no disability (or responding "not at all" limited, difficult or bothersome to all questions answered). Therefore a positive change in score corresponds to improvement in AF symptoms. | Subset of Safety Population with non-missing AFEQT data at 12 months. | Posted | Mean | Standard Deviation | units on a scale | Screening to 12 Month Visit |
|
|
Procedure through 7 days post-procedure
Not provided
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 | Catheter Ablation | These patients have drug refractory, recurrent, symptomatic paroxysmal atrial fibrillation, are aged 18 years or older, and are able and willing to provide written informed consent to participate in the study. Catheter Ablation (NAVISTAR® THERMOCOOL® SF Catheter): Administer anesthesia according to standard EP lab protocol, assess the fluid status of the subject (after each liter of infusate), determine if diuresis is necessary, and treat accordingly. | 63 | 508 | 79 | 508 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atrial fibrillation | Cardiac disorders | Non-systematic Assessment |
| ||
| Cardiac tamponade | Cardiac disorders | Non-systematic Assessment |
| ||
| Pericardial effusion | Cardiac disorders | Non-systematic Assessment |
| ||
| Pericarditis | Cardiac disorders | Non-systematic Assessment |
| ||
| Cardiac failure congestive | Cardiac disorders | Non-systematic Assessment |
| ||
| Atrial tachycardia | Cardiac disorders | Non-systematic Assessment |
| ||
| Atrial flutter | Cardiac disorders | Non-systematic Assessment |
| ||
| Cardiac arrest | Cardiac disorders | Non-systematic Assessment |
| ||
| Cardiac perforation | Cardiac disorders | Non-systematic Assessment |
| ||
| Sick sinus syndrome | Cardiac disorders | Non-systematic Assessment |
| ||
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Bronchospasm | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Dyspnea exertional | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Epistaxis | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Hypoxia | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Anemia | Blood and lymphatic system disorders | Non-systematic Assessment |
| ||
| Leukocytosis | Blood and lymphatic system disorders | Non-systematic Assessment |
| ||
| Abdominal pain | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Dysphagia | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Gastrointestinal hemorrhage | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Intestinal obstruction | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Catheter site hematoma | General disorders | Non-systematic Assessment |
| ||
| Device difficult to use (foley) | General disorders | Non-systematic Assessment |
| ||
| Non-cardiac chest pain | General disorders | Non-systematic Assessment |
| ||
| Pyrexia | General disorders | Non-systematic Assessment |
| ||
| Pneumonia | Infections and infestations | Non-systematic Assessment |
| ||
| Urinary tract infection | Infections and infestations | Non-systematic Assessment |
| ||
| Subdural hematoma | Injury, poisoning and procedural complications | Non-systematic Assessment |
| ||
| Vascular pseudoaneurysm | Injury, poisoning and procedural complications | Non-systematic Assessment |
| ||
| International normalized ratio decreased | Investigations | Non-systematic Assessment |
| ||
| Electrocardiogram ST segment depression | Investigations | Non-systematic Assessment |
| ||
| Hematocrit decreased | Investigations | Non-systematic Assessment |
| ||
| Hemoglobin decreased | Investigations | Non-systematic Assessment |
| ||
| Hyperglycemia | Metabolism and nutrition disorders | Non-systematic Assessment |
| ||
| Hyponatremia | Metabolism and nutrition disorders | Non-systematic Assessment |
| ||
| Syncope | Nervous system disorders | Non-systematic Assessment |
| ||
| Transient global amnesia | Nervous system disorders | Non-systematic Assessment |
| ||
| Hematuria | Renal and urinary disorders | Non-systematic Assessment |
| ||
| Proteinuria | Renal and urinary disorders | Non-systematic Assessment |
| ||
| Renal failure acute | Renal and urinary disorders | Non-systematic Assessment |
| ||
| Urinary retention | Renal and urinary disorders | Non-systematic Assessment |
| ||
| Femoral artery aneurysm | Vascular disorders | Non-systematic Assessment |
| ||
| Hypotension | Vascular disorders | Non-systematic Assessment |
| ||
| Intra-abdominal hematoma | Vascular disorders | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atrial fibrillation | Cardiac disorders | Non-systematic Assessment |
| ||
| Pericarditis | Cardiac disorders | Non-systematic Assessment |
| ||
| Nausea | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Pyrexia | General disorders | Non-systematic Assessment |
| ||
| Catheter site hematoma | Injury, poisoning and procedural complications | Non-systematic Assessment |
| ||
| Catheter site hemorrhage | Injury, poisoning and procedural complications | Non-systematic Assessment |
| ||
| Fluid Overload | Metabolism and nutrition disorders | Non-systematic Assessment |
| ||
| Back pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| ||
| Dizziness | Nervous system disorders | Non-systematic Assessment |
| ||
| Dyspnea | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Hypotension | Vascular disorders | Non-systematic Assessment |
|
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 |
Not provided
Not provided
| ID | Term |
|---|---|
| D017115 | Catheter Ablation |
| ID | Term |
|---|---|
| D000078703 | Radiofrequency Ablation |
| D000078702 | Radiofrequency Therapy |
| D013812 | Therapeutics |
| D055011 | Ablation Techniques |
| D013514 | Surgical Procedures, Operative |
Not provided
Not provided
| Unknown or Not Reported |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
|
|
|
|
|
|
|
|
|
|
|