Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| CRD_978 | Other Identifier | Abbott |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Prospective non-randomized parallel-assignment multi-center clinical investigation. The study design includes two subject cohorts: 1) Paroxysmal Atrial Fibrillation Main Study, and 2) Paroxysmal Atrial Fibrillation High Standard Power Substudy. Subjects in the main study cohorts are to be treated using the full range of ablation power settings in the Instructions For Use. Subjects in the High Standard Power Substudy are to be treated in the upper end of the recommended ablation power settings (40-50 Watts).
This clinical investigation is intended to demonstrate the safety and effectiveness of the TactiFlex(TM) Ablation Catheter, Sensor Enabled(TM) (TactiFlex SE) for treating drug-refractory, symptomatic paroxysmal atrial fibrillation. This clinical investigation will be conducted under an investigational device exemption and is intended to support market approval of the TactiFlex SE catheter worldwide. Three hundred and Fifty Five (355) subjects will be enrolled at up to 50 investigational sites worldwide. This clinical investigation is sponsored by Abbott.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Main Study | Experimental |
| |
| High Standard Power Sub-Study | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TactiFlex SE | Device | Radiofrequency ablation with the TactiFlex SE ablation catheter. The procedure should be performed according to the TactiFlex SE investigational Instructions for Use document using the recommended ablation parameters as noted in the document. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Device or Procedure-related Serious Adverse Events | Tthe rate of device and/or procedure-related serious adverse events with onset within 7-days of any ablation procedure that uses the TactiFlex SE catheter (initial or repeat procedure performed 31-80 days of initial procedure) that are defined below:
| Through 12 months |
| KM Rate of Freedom From Atrial Fibrillation, Atrial Flutter or Atrial Tachycardia Recurrence | Freedom from documented (symptomatic or asymptomatic) Atrial Fibrillation/Atrial Flutter/Atrial Tachycardia episodes of >30 seconds duration that are documented by 12-lead ECG, transtelephonic monitoring or Holter monitor after the initial catheter ablation procedure through 12-months of follow-up. Recurrence during the 90-day blanking period will not be considered a treatment failure. One repeat procedure will be allowed during the blanking period. Failure to achieve acute procedural success during the last ablation procedure with the TactiFlex SE catheter will constitute failure. After the 90-day blanking period, use of Class I or III anti-arrhythmic drugs will not count as a therapy failure provided that only previously failed drugs are taken at doses that do not exceed the previously failed dose. | Through 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| KM Rate of Freedom From Symptomatic Atrial Fibrillation, Atrial Flutter or Atrial Tachycardia Recurrence | Freedom from documented symptomatic atrial fibrillation/atrial flutter/atrial tachycardia episodes of >30 seconds duration that are documented by 12-lead ECG, transtelephonic monitoring or Holter monitor after the initial catheter ablation procedure through 12-months of follow-up. Recurrence during the 90-day blanking period (≤90 days post-initial procedure) will not be considered a treatment failure. One repeat procedure will be allowed for ablation 31-80 days after the initial procedure and will not be considered a treatment failure. Failure to achieve acute procedural success during the last ablation procedure with the TactiFlex SE catheter will constitute failure. After the 90-day blanking period, use of Class I or III anti-arrhythmias drugs will not count as a therapy failure provided that only previously failed Class I or III anti-arrhythmias drugs are taken at doses that do not exceed the previously failed dose. |
Not provided
A patient will be eligible for clinical trial participation if he/she meets the following criteria:
A patient will be excluded from enrollment in the clinical trial if he/she meets any of the following criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Kristin Ruffner, PhD | Clinical Program Director | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Affinity Cardiovascular Specialists, LLC | Birmingham | Alabama | 35243 | United States | ||
| St. Bernards Medical Center |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Paroxysmal AF - Main Study | TactiFlex SE: Radiofrequency ablation with the TactiFlex SE ablation catheter. The procedure should be performed according to the TactiFlex SE investigational Instructions for Use document using the recommended ablation parameters as noted in the document. |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 29, 2020 | Jul 27, 2023 |
Not provided
Not provided
This is a prospective non-randomized parallel-assignment multi-center clinical investigation. The study design includes two subject cohorts: 1) Paroxysmal Atrial Fibrillation Main Study, and 2) Paroxysmal Atrial Fibrillation High Standard Power Substudy. Subjects in the main study cohorts are to be treated using the full range of ablation power settings in the Instructions For Use. Subjects in the Substudy are to be treated in the upper end of the recommended ablation power settings (40-50 Watts).
Not provided
Not provided
Not provided
Not provided
|
| TactiFlex SE - High Standard Power | Device | Radiofrequency ablation with the TactiFlex SE ablation catheter. Subjects in the High Standard Power Substudy are to undergo the same study procedures as subjects in the main study, except that ablation power settings of 40-50 Watts are to be used in the left atrium, unless there is a medical reason to use a lower power. |
|
| Through 12 months |
| KM Rate of Freedom From Atrial Fibrillation, Atrial Flutter or Atrial Tachycardia Recurrence With Only 1 Ablation Procedure | Freedom from documented (symptomatic or asymptomatic) Atrial Fibrillation/Atrial Flutter/Atrial Tachycardia episodes of >30 seconds duration that are documented by 12-lead ECG, transtelephonic monitoring or Holter monitor after the initial catheter ablation procedure through 12-months of follow-up. Recurrence during the 90-day blanking period (≤90 days post-initial procedure) will not be considered a treatment failure. Any repeat ablation procedure in the left atrium will be considered a treatment failure. Failure to achieve acute procedural success during the ablation procedure with the TactiFlex SE catheter will constitute failure. After the 90-day blanking period, use of Class I or III anti-arrhythmic drugs will not count as a therapy failure provided that only previously failed Class I or III anti-arrhythmic drugs are taken at doses that do not exceed the previously failed dose. | 12 months |
| KM Rate of Freedom From Atrial Fibrillation, Atrial Flutter or Atrial Tachycardia Recurrence, Without Anti-arrhythmic Drugs | Freedom from documented (symptomatic or asymptomatic) Atrial Fibrillation/Atrial Flutter/Atrial Tachycardia episodes of >30 seconds duration that are documented by 12-lead ECG, transtelephonic monitoring or Holter monitor after the initial catheter ablation procedure through 12-months of follow-up (9 months after a 90-day blanking period). Recurrence during the 90-day blanking period (≤90 days post-initial procedure) will not be considered a treatment failure. One repeat procedure will be allowed for ablation 31-80 days after the initial procedure and will not be considered a treatment failure. Failure to achieve acute procedural success during the last ablation procedure with the TactiFlex SE catheter will constitute failure. After the 90-day blanking period, any use of a Class I or III anti-arrhythmic drugs will count as an effectiveness failure. | Through 12 months |
| Jonesboro |
| Arkansas |
| 72401 |
| United States |
| Arkansas Heart Hospital | Little Rock | Arkansas | 72211 | United States |
| Mills-Peninsula Medical Center | Burlingame | California | 94010 | United States |
| Scripps Health | La Jolla | California | 92037 | United States |
| University of California at San Diego (UCSD) Medical Center | San Diego | California | 92103 | United States |
| South Denver Cardiology Associates PC | Littleton | Colorado | 80120 | United States |
| AdventHealth Orlando | Orlando | Florida | 32806 | United States |
| Piedmont Athens Regional Medical Center | Athens | Georgia | 30309 | United States |
| St. Luke's Regional Medical Center | Boise | Idaho | 83712 | United States |
| Kootenai Heart Clinics | Coeur d'Alene | Idaho | 83814 | United States |
| St. Vincent Hospital | Indianapolis | Indiana | 46260 | United States |
| Iowa Heart Center | West Des Moines | Iowa | 50266 | United States |
| Kansas City Cardiac Arrhythmia Research Foundation | Overland Park | Kansas | 66211 | United States |
| Ochsner Medical Center | New Orleans | Louisiana | 70121 | United States |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
| Providence Hospital | Southfield | Michigan | 48075 | United States |
| Jackson Heart Clinic | Jackson | Mississippi | 39216 | United States |
| North Mississippi Medical Center | Tupelo | Mississippi | 38801 | United States |
| New York University Hospital | New York | New York | 10016 | United States |
| New York-Presbyterian/Columbia University Medical Center | New York | New York | 10032 | United States |
| NC Heart & Vascular Research | Raleigh | North Carolina | 27607 | United States |
| The Cleveland Clinic Foundation | Cleveland | Ohio | 44195 | United States |
| Ohio State University | Columbus | Ohio | 43210 | United States |
| Hospital of the University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
| Medical University of South Carolina | Charleston | South Carolina | 29425 | United States |
| Texas Cardiac Arrhythmia Research Foundation | Austin | Texas | 78705 | United States |
| Memorial Hermann Hospital | Houston | Texas | 77380 | United States |
| The Heart Hospital Baylor Plano | Plano | Texas | 75204 | United States |
| Franciscan Heart & Vascular Associates | Tacoma | Washington | 98405 | United States |
| Westmead Hospital | Westmead | New South Wales | 2145 | Australia |
| Wesley Private Hospital | Auchenflower | Queensl | 4066 | Australia |
| The Prince Charles Hospital | Chermside | Queensl | 4032 | Australia |
| Monash Medical Centre | Clayton | Victori | 3168 | Australia |
| Royal Adelaide Hospital | Adelaide | 5067 | Australia |
| A. ö. Krankenhaus der Elisabethinen Linz | Linz | UPR AUS | 4020 | Austria |
| Kingston General Hospital | Kingston | Ontario | K7L 2V7 | Canada |
| Sunnybrook Health Sciences Centre | Toronto | Ontario | M4N 3M5 | Canada |
| IKEM Prague | Prague | Cbohmia | 14021 | Czechia |
| Herz-und Diabetes Zentrum NRW | Bad Oeynhausen | N. RHIN | 32545 | Germany |
| Herzzentrum Leipzig GmbH | Leipzig | 4289 | Germany |
| Prince of Wales Hospital | Hong Kong | HONG KO | Hong Kong |
| Ospedale San Raffaele | Milan | Lombard | 20132 | Italy |
| Erasmus MC - Thoraxcenter | Rotterdam | S Holln | 3015 | Netherlands |
| Taipei Veterans General Hospital (VGH) | Taipei | Ntaiwan | 11217 | Taiwan |
| Paroxysmal AF HSP Sub-Study |
TactiFlex SE - HSP: Radiofrequency ablation with the TactiFlex SE ablation catheter. Subjects in the HSP Substudy are to undergo the same study procedures as subjects in the main study, except that ablation power settings of 40-50 Watts are to be used in the left atrium, unless there is a medical reason to use a lower power. |
| Device Inserted and RF Energy Delivered |
|
| 7-Day Visit |
|
| 5-Week Visit |
|
| 3-Month Visit |
|
| 6-Month Visit |
|
| 12-Month Visit |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Paroxysmal AF - Main Study | TactiFlex SE: Radiofrequency ablation with the TactiFlex SE ablation catheter. The procedure should be performed according to the TactiFlex SE investigational Instructions for Use document using the recommended ablation parameters as noted in the document. |
| BG001 | Paroxysmal AF HSP Sub-Study | TactiFlex SE - HSP: Radiofrequency ablation with the TactiFlex SE ablation catheter. Subjects in the HSP Substudy are to undergo the same study procedures as subjects in the main study, except that ablation power settings of 40-50 Watts are to be used in the left atrium, unless there is a medical reason to use a lower power. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Inter-Quartile Range | 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 |
| ||||||||||||||||
| Body Mass Index | Median | Inter-Quartile Range | kg/m^2 |
| |||||||||||||||
| CHA2DS2Vasc Score | This scoring system includes the following risk factors C for Congestive heart failure adds 1 point. H for Hypertension or high blood pressure adds 1 point A for Age greater than or equal to 75 years adds 2 points D for Diabetes mellitus or type 2 diabetes adds 1 point S for prior Stroke or TIA adds 2 points V for Vascular disease adds 1 point A for Age between 65 and 74 years adds 1 point S for female Sex adds 1 point Range 0-9. A higher score is considered at higher risk for stroke. Note: while the points above add to 10, you can only have a max of 2 points for age. | Median | Inter-Quartile Range | units on a scale |
| ||||||||||||||
| New York Heart Association Functional Classification | The New York Heart Association Functional Classification provides a simple way of classifying the extent of heart failure. It places patients in one of four categories based on how much they are limited during physical activity; the limitations/symptoms are in regard to normal breathing and varying degrees in shortness of breath and/or angina. Class I = no limitation of physical activity. Class II = slight limitation Class III = marked limitation Class IV = unable to carry on any physical activity without discomfort | Count of Participants | Participants |
| |||||||||||||||
| Left Ventricular Ejection Fraction | Percentage of left ventricular ejection as determined using an echo or computerized tomography scan. | Median | Inter-Quartile Range | Percentage |
| ||||||||||||||
| Left Atrial Diameter | As measured by an echo or computerized tomography scan. | Median | Inter-Quartile Range | Millimeters |
|
| 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 | Number of Participants With Device or Procedure-related Serious Adverse Events | Tthe rate of device and/or procedure-related serious adverse events with onset within 7-days of any ablation procedure that uses the TactiFlex SE catheter (initial or repeat procedure performed 31-80 days of initial procedure) that are defined below:
| The primary safety analysis population for the primary safety endpoint included all treated subjects who have completed their 7-day follow-up visit; or crossed the end of the 7-day visit window without the visit but with a primary safety endpoint event. | Posted | Count of Participants | Participants | Through 12 months |
|
|
| |||||||||||||||||||||||||||||
| Primary | KM Rate of Freedom From Atrial Fibrillation, Atrial Flutter or Atrial Tachycardia Recurrence | Freedom from documented (symptomatic or asymptomatic) Atrial Fibrillation/Atrial Flutter/Atrial Tachycardia episodes of >30 seconds duration that are documented by 12-lead ECG, transtelephonic monitoring or Holter monitor after the initial catheter ablation procedure through 12-months of follow-up. Recurrence during the 90-day blanking period will not be considered a treatment failure. One repeat procedure will be allowed during the blanking period. Failure to achieve acute procedural success during the last ablation procedure with the TactiFlex SE catheter will constitute failure. After the 90-day blanking period, use of Class I or III anti-arrhythmic drugs will not count as a therapy failure provided that only previously failed drugs are taken at doses that do not exceed the previously failed dose. | All treated subjects | Posted | Number | 97.5% Confidence Interval | percentage | Through 12 months |
| ||||||||||||||||||||||||||||||
| Secondary | KM Rate of Freedom From Symptomatic Atrial Fibrillation, Atrial Flutter or Atrial Tachycardia Recurrence | Freedom from documented symptomatic atrial fibrillation/atrial flutter/atrial tachycardia episodes of >30 seconds duration that are documented by 12-lead ECG, transtelephonic monitoring or Holter monitor after the initial catheter ablation procedure through 12-months of follow-up. Recurrence during the 90-day blanking period (≤90 days post-initial procedure) will not be considered a treatment failure. One repeat procedure will be allowed for ablation 31-80 days after the initial procedure and will not be considered a treatment failure. Failure to achieve acute procedural success during the last ablation procedure with the TactiFlex SE catheter will constitute failure. After the 90-day blanking period, use of Class I or III anti-arrhythmias drugs will not count as a therapy failure provided that only previously failed Class I or III anti-arrhythmias drugs are taken at doses that do not exceed the previously failed dose. | All Treated Subjects | Posted | Number | 97.5% Confidence Interval | percentage | Through 12 months |
| ||||||||||||||||||||||||||||||
| Secondary | KM Rate of Freedom From Atrial Fibrillation, Atrial Flutter or Atrial Tachycardia Recurrence With Only 1 Ablation Procedure | Freedom from documented (symptomatic or asymptomatic) Atrial Fibrillation/Atrial Flutter/Atrial Tachycardia episodes of >30 seconds duration that are documented by 12-lead ECG, transtelephonic monitoring or Holter monitor after the initial catheter ablation procedure through 12-months of follow-up. Recurrence during the 90-day blanking period (≤90 days post-initial procedure) will not be considered a treatment failure. Any repeat ablation procedure in the left atrium will be considered a treatment failure. Failure to achieve acute procedural success during the ablation procedure with the TactiFlex SE catheter will constitute failure. After the 90-day blanking period, use of Class I or III anti-arrhythmic drugs will not count as a therapy failure provided that only previously failed Class I or III anti-arrhythmic drugs are taken at doses that do not exceed the previously failed dose. | All treated subjects | Posted | Number | 97.5% Confidence Interval | percentage | 12 months |
| ||||||||||||||||||||||||||||||
| Secondary | KM Rate of Freedom From Atrial Fibrillation, Atrial Flutter or Atrial Tachycardia Recurrence, Without Anti-arrhythmic Drugs | Freedom from documented (symptomatic or asymptomatic) Atrial Fibrillation/Atrial Flutter/Atrial Tachycardia episodes of >30 seconds duration that are documented by 12-lead ECG, transtelephonic monitoring or Holter monitor after the initial catheter ablation procedure through 12-months of follow-up (9 months after a 90-day blanking period). Recurrence during the 90-day blanking period (≤90 days post-initial procedure) will not be considered a treatment failure. One repeat procedure will be allowed for ablation 31-80 days after the initial procedure and will not be considered a treatment failure. Failure to achieve acute procedural success during the last ablation procedure with the TactiFlex SE catheter will constitute failure. After the 90-day blanking period, any use of a Class I or III anti-arrhythmic drugs will count as an effectiveness failure. | All treated subjects | Posted | Number | 97.5% Confidence Interval | percentage | Through 12 months |
|
12 months
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 | Paroxysmal AF - Main Study | TactiFlex SE: Radiofrequency ablation with the TactiFlex SE ablation catheter. The procedure should be performed according to the TactiFlex SE investigational Instructions for Use document using the recommended ablation parameters as noted in the document. | 2 | 284 | 65 | 284 | 5 | 284 |
| EG001 | Paroxysmal AF HSP Sub-Study | TactiFlex SE - HSP: Radiofrequency ablation with the TactiFlex SE ablation catheter. Subjects in the HSP Substudy are to undergo the same study procedures as subjects in the main study, except that ablation power settings of 40-50 Watts are to be used in the left atrium, unless there is a medical reason to use a lower power. | 0 | 50 | 8 | 50 | 3 | 50 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Infection | Infections and infestations | Non-systematic Assessment |
| ||
| Arrhythmia Pre-Existing | Cardiac disorders | Non-systematic Assessment |
| ||
| Cancer/Non-Malignant Tumor | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
| ||
| Pericarditis | Cardiac disorders | Non-systematic Assessment |
| ||
| Pulmonary Edema | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Chest Pain/Angina (Cardiac) | Cardiac disorders | Non-systematic Assessment |
| ||
| Musculoskeletal Disorder | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| ||
| Vascular Access Complications | Vascular disorders | Non-systematic Assessment |
| ||
| Cardiac Tamponade | Cardiac disorders | Non-systematic Assessment |
| ||
| Coronary Artery Disease | Vascular disorders | Non-systematic Assessment |
| ||
| Pain (Non-Cardiac) | General disorders | Non-systematic Assessment |
| ||
| Pericardial Effusion | Cardiac disorders | Non-systematic Assessment |
| ||
| Syncope/Dizziness | General disorders | Non-systematic Assessment |
| ||
| Thrombosis/Thrombus | Cardiac disorders | Non-systematic Assessment |
| ||
| Vascular Bleeding/Local Hematomas Ecchymosis | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
| ||
| Abnormal Labs (e.g., Creatine phosphokinase, Creatinine, Troponin) | General disorders | Non-systematic Assessment |
| ||
| Arrhythmia New | Cardiac disorders | Non-systematic Assessment |
| ||
| Atrioventricular Block/Bundle Branch Block | Cardiac disorders | Non-systematic Assessment |
| ||
| Bleeding/Anemia | Blood and lymphatic system disorders | Non-systematic Assessment |
| ||
| Cardiac Perforation/Injury | Cardiac disorders | Non-systematic Assessment |
| ||
| Cerebrovascular Accident/Stroke | Blood and lymphatic system disorders | Non-systematic Assessment |
| ||
| Endocrine Disease/Disorder | Endocrine disorders | Non-systematic Assessment |
| ||
| Heart Failure/Pump Failure | Cardiac disorders | Non-systematic Assessment |
| ||
| Nerve System Damage/Injury/Disease | Nervous system disorders | Non-systematic Assessment |
| ||
| Renal Decompensation/Kidney Injury | Renal and urinary disorders | Non-systematic Assessment |
| ||
| Transient Ischemic Attack | Blood and lymphatic system disorders | Non-systematic Assessment |
| ||
| Valvular Damage or Insufficiency | Cardiac disorders | Non-systematic Assessment |
| ||
| Vascular Damage (e.g., Perforation, Dissection, Obstruction) | Injury, poisoning and procedural complications | Non-systematic Assessment |
| ||
| Vasovagal Reaction | General disorders | Non-systematic Assessment |
| ||
| Volume Overload | General disorders | Non-systematic Assessment |
| ||
| Abnormal Vision | Eye disorders | Non-systematic Assessment |
| ||
| Elective Procedure/Surgery | Surgical and medical procedures | Non-systematic Assessment |
| ||
| Other: Diarrhea | General disorders | Non-systematic Assessment |
| ||
| Other: Urinary/Urine Retention | Renal and urinary disorders | Non-systematic Assessment |
| ||
| Other: Abdominal Pain | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Other: Aortic Stenosis | Cardiac disorders | Non-systematic Assessment |
| ||
| Other: Atrial Fibrillation | Cardiac disorders | Non-systematic Assessment |
| ||
| Other: Collapsed Lung | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Other: Motorcycle Crash | General disorders | Non-systematic Assessment |
| ||
| Other: Pericardial-Esophageal Fistula | Cardiac disorders | Non-systematic Assessment |
| ||
| Other: Pseudoaneurysm of Common Femoral Artery | Injury, poisoning and procedural complications | Non-systematic Assessment |
| ||
| Other: Pulmonary Sarcoidosis | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Other: Spontaneous Subarachnoid Hemorrhage | General disorders | Non-systematic Assessment |
| ||
| Other: Ureteral Calculus/Stone | Renal and urinary disorders | Non-systematic Assessment |
| ||
| Other: Urinary Frequency Needing transurethral resection of the prostate | Renal and urinary disorders | Non-systematic Assessment |
| ||
| Other: Urinary Retention with Acute Kidney Injury | General disorders | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Volume Overload | Endocrine disorders | Non-systematic Assessment |
|
The data and results from the clinical investigation are the sole property of the Sponsor. The Investigators will not use this clinical investigation-related data without the written consent of the Sponsor for any purpose other than for clinical investigation completion or for generation of publication materials, as referenced in the Clinical Trial Agreement. Single-center results are not allowed to be published or presented before the multi-center results.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Anne Sarver | Abbott | 6517563813 | anne.sarver@abbott.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 15, 2020 | Oct 5, 2023 | SAP_002.pdf |
Not provided
| 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
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Austria |
|
| Hong Kong |
|
| United States |
|
| Czechia |
|
| Taiwan |
|
| Italy |
|
| Australia |
|
| Germany |
|
| Class I |
|
| Class II |
|
| Class III or IV |
|
|
|
TactiFlex SE - High Standard Power: Radiofrequency ablation with the TactiFlex SE ablation catheter. Subjects in the High Standard Power Substudy are to undergo the same study procedures as subjects in the main study, except that ablation power settings of 40-50 Watts are to be used in the left atrium, unless there is a medical reason to use a lower power.
|
|
|
|
|
|