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| Name | Class |
|---|---|
| Biosense Webster, Inc. | INDUSTRY |
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The primary purpose of this Registry is to assess procedural safety and long-term effectiveness of catheter ablations in the treatment of subjects with PAF, PsAF, and VA. The Registry will utilize real world clinical data obtained from the use of commercially available CARTOâ„¢ technologies under the authority of a health care practitioner within a legitimate practitioner-subject relationship. Data from the registry will be used to assess clinical outcomes, including procedural efficiency, safety, and long-term effectiveness of catheter ablation with novel technologies for arrhythmia patients.
The REAL Registry is an observational, prospective, multi-center, non-randomized registry designed to obtain real-world clinical experience of ablation using Biosense Webster, Inc. (BWI) CARTO technologies (e.g., THERMOCOOL SMARTTOUCH®, THERMOCOOL SMARTTOUCH® SF, QDOT MICRO™, VARIPULSE™). Future new Biosense Webster, Inc. technologies, including new thermal and/or pulsed field ablation (PFA), may be included as they become commercially available.
Current clinical practice guidelines recommend ablation for ventricular arrhythmias (VA) and atrial fibrillation (AF)1,2. Therefore, REAL AF will include subjects with symptomatic paroxysmal AF (PAF), persistent AF (PsAF) who meet all eligibility criteria and in the opinion of the investigator, are candidates for AF catheter ablation. CORE-VA will include all subjects with documented ventricular arrhythmia appropriate for catheter ablation.
All subjects will be treated with commercially approved BWI ablation catheters, and the ablation procedure will be conducted based on the participating Site's current standard of care (SOC). Participation in the Registry does not influence treatment decisions. All consecutive subjects presenting at the Site considered for an ablation procedure should be screened by the Investigator or a designated member of the research team for eligibility.
The objective of this registry is to assess clinical outcomes, including procedural efficiency, safety, long-term, effectiveness of RF ablations in the treatment of patients with Paroxysmal or Persistent atrial fibrillation. The outcomes of the registry are: 1) long term effectiveness defined as freedom from Arrhythmia recurrence post 90-day blanking period, 2) acute safety defined by serious complications within 7 days post ablation and up to 30 days post ablation.
Sites and Investigators considered for inclusion in the Registry will be assessed to determine if their practice patterns align, minimally, with what is outlined in VISIT SCHEDULE AND DATA COLLECTION of this protocol for the specific cohort in which the investigators will be enrolling. Investigators need to only align with the requirements of one cohort, but can participate in both, if qualified, and selected in each cohort. The Registry does not require any additional visits above what is considered standard of care follow-up for the Registry subject population.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| REAL AF | Subjects with symptomatic PAF or PsAF who, in the opinion of the investigator, are candidates for ablation for AF, age 18 years or older, and are able and willing to comply with all pre-, post-, and follow-up testing and requirements. |
| |
| CORE VA | Subjects with documented ventricular arrhythmia appropriate for catheter ablation, greater than 18 years of age, will be treated with Biosense Webster Inc. ablation technologies, and are willing and able to participate in baseline and follow up evaluations. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Catheter ablation | Device | Ablation using Biosense Webster, Inc. (BWI) CARTO™ technologies (e.g., THERMOCOOL SMARTTOUCH® SF, QDOT MICRO™, VARIPULSE™). Future new Biosense Webster, Inc. technologies, including new thermal and/or pulsed field ablation (PFA), may be included as they become commercially available. |
| Measure | Description | Time Frame |
|---|---|---|
| Effectiveness at 90 days | Freedom from arrhythmia recurrence at 90 days post procedure. | 90 days |
| Effectiveness at 12 months | Freedom from subject reported arrhythmia recurrence through 12 months post procedure. | 12 months |
| Long-term Safety | Incidence of late onset complications, 30 days post-ablation which are procedure and/or device related | 30 days post ablation |
| Measure | Description | Time Frame |
|---|---|---|
| Arrhythmia recurrence | Recurrence seen during monitoring with Dual/ CRT Pacer or ICD; Event Monitor; LinQ; Holter; EKG; TTE | 12 months |
| Post-procedure arrhythmia treatments | Treatments for arrhythmia post-procedure |
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REAL AF Cohort
Inclusion Criteria:
Exclusion Criteria:
CORE VA Cohort
Inclusion Criteria:
Exclusion Criteria:
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Study population consists of adults age 18 years or older with symptomatic Paroxysmal and Persistent Atrial Fibrillation who are candidates for ablation in the REAL AF Cohort and adults age 18 years or older with documented ventricular arrhythmia appropriate for catheter ablation in the CORE VA Cohort.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jennifer White, MS | Contact | 1-629-335-8261 | jwhite@hrcrs.com | |
| Jose Osorio, MD | Contact | josorio@hrcrs.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham | Recruiting | Birmingham | Alabama | 35233 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37254771 | Background | Sharma E, Varley A, Osorio J, Thorne C, Varosy P, Metzl M, Rajendra A, Oza S, Morales G, Magnano A, D'Souza B, Sackett M, Sellers M, Silva J, Silverstein J, Ho J, Hoskins M, Kuk R, Romero J, Zei PC. Procedural Trends in Catheter Ablation of Persistent Atrial Fibrillation: Insights From the Real-AF Registry. Circ Arrhythm Electrophysiol. 2023 Jun;16(6):e011828. doi: 10.1161/CIRCEP.123.011828. Epub 2023 May 31. No abstract available. | |
| 35438393 |
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| 12 months |
| Arrhythmia related symptoms | Presence of: weakness, fluttering, SOB, fatigue, dizziness, decrease in exercise tolerance, chest pain/pressure, heart racing/palpitations, and other (yes/no) | 12 months |
| AAD Usage | Antiarrhythmic drug use (and type) post procedure and 12 months | 12 months |
| OAC usage | Oral anticoagulant use at 12 months and drug type | 12 months |
| CHA2DS2VASC | An estimation of stroke risk for patients with Atrial Fibrillation. Composite score of: Age (<65= 0; 65-74=1; >75=2) + Sex (Female=1; Male=0) + Congestive Heart Failure (Yes =1; No=0) + Hypertension (Yes= 1; No= 0) + Stroke, Transient Ischemic Attack (TIA) or thromboembolism (Yes=2; No=0) + Vascular Disease (Yes=1; No=0) + Diabetes (Yes=1; No=0). Scores range from 0 to 9, with higher scores indicating greater risk for stroke. | 12 months |
| Patient reported outcome | How do you feel now compared to pre-ablation? | 12 months |
| Grandview Medical Center | Recruiting | Birmingham | Alabama | 35243 | United States |
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| Cardiology Associates of Mobile | Recruiting | Mobile | Alabama | 36695 | United States |
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| Valley Heart Rhythm Specialists | Recruiting | Chandler | Arizona | 85224 | United States |
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| Pima Heart and Vascular | Recruiting | Tucson | Arizona | 85741 | United States |
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| Arrhythmia Research Group | Recruiting | Jonesboro | Arkansas | 72401 | United States |
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| Keck School of Medicine | Recruiting | Los Angeles | California | 90033 | United States |
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| Santa Barbara Cottage Hospital | Terminated | Santa Barbara | California | 93105 | United States |
| Community Memorial Hospital | Recruiting | Ventura | California | 93303 | United States |
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| University HealthCare Alliance | Completed | Walnut Creek | California | 94598 | United States |
| The Medical Center of Aurora | Recruiting | Aurora | Colorado | 80012 | United States |
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| Colorado Heart and Vascular | Recruiting | Golden | Colorado | 80401 | United States |
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| South Denver Cardiology | Recruiting | Littleton | Colorado | 80120 | United States |
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| Ascension St. Vincent's | Recruiting | Jacksonville | Florida | 32204 | United States |
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| HCA Florida Mercy Hospital | Recruiting | Miami | Florida | 33133 | United States |
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| Naples Community Hospital | Recruiting | Naples | Florida | 34101 | United States |
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| Ascension Sacred Heart | Recruiting | Pensacola | Florida | 32504 | United States |
|
| Sarasota Memorial Hospital | Recruiting | Sarasota | Florida | 34239 | United States |
|
| Baycare Health Tampa | Recruiting | Tampa | Florida | 33606 | United States |
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| Baycare Health System | Recruiting | Winterhaven | Florida | 33881 | United States |
|
| Piedmont Healthcare | Recruiting | Atlanta | Georgia | 30309 | United States |
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| Memorial Health University Medical Center | Recruiting | Savannah | Georgia | 31404 | United States |
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| The Queen's Medical Center | Recruiting | Honolulu | Hawaii | 97813 | United States |
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| Northshore University Health System | Recruiting | Evanston | Illinois | 60201 | United States |
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| Midwest Cardiovascular Institute | Recruiting | Naperville | Illinois | 60540 | United States |
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| Prairie Education and Research | Recruiting | Springfield | Illinois | 62704 | United States |
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| Ascension St. Vincent's Hospital | Recruiting | Indianapolis | Indiana | 46260 | United States |
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| University of Iowa | Recruiting | Iowa City | Iowa | 52242 | United States |
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| Norton Heart Specialists | Recruiting | Louisville | Kentucky | 40205 | United States |
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| Baptist Health Louisville | Recruiting | Saint Matthews | Kentucky | 40207 | United States |
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| Maine Medical Center | Recruiting | Portland | Maine | 04102 | United States |
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| Capitol CArdiology | Recruiting | Lanham | Maryland | 20706 | United States |
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| Brigham and Women's Hospital | Recruiting | Boston | Massachusetts | 02115 | United States |
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| Henry Ford Health | Recruiting | Detroit | Michigan | 48202 | United States |
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| McLaren Greater Lansing | Active, not recruiting | Lansing | Michigan | 48910 | United States |
| Sparrow Clinical Research | Recruiting | Lansing | Michigan | 48912 | United States |
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| William Beaumont Hospital | Recruiting | Royal Oak | Michigan | 48073 | United States |
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| Michigan Heart | Recruiting | Ypsilanti | Michigan | 48197 | United States |
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| Mississippi Baptist Medical Center | Recruiting | Jackson | Mississippi | 39202 | United States |
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| University of Missouri | Recruiting | Columbia | Missouri | 65212 | United States |
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| CoxHealth | Recruiting | Springfield | Missouri | 65807 | United States |
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| Cardiovascular Associates of the Delaware Valley | Recruiting | Haddon Heights | New Jersey | 08035 | United States |
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| Lovelace Health System | Recruiting | Albuquerque | New Mexico | 87102 | United States |
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| Columbia University Medical Center / NewYork-Presbyterian Hospital (CUMC/NYPH) | Recruiting | New York | New York | 10032 | United States |
|
| Nuvance Health | Recruiting | Poughkeepsie | New York | 12601 | United States |
|
| Crouse Health System and Crouse Medical Practice | Recruiting | Syracuse | New York | 13210 | United States |
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| Mission Hospital | Recruiting | Asheville | North Carolina | 28801 | United States |
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| Novant Health Forsyth Medical Center | Recruiting | Winston-Salem | North Carolina | 27103 | United States |
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| University of Cincinnati | Recruiting | Cincinnati | Ohio | 45202 | United States |
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| The Christ Hospital | Recruiting | Cincinnati | Ohio | 45219 | United States |
|
| Mount Carmel Columbus Cardiology Consultants | Recruiting | Columbus | Ohio | 43213 | United States |
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| Oklahoma Heart Hospital | Recruiting | Oklahoma City | Oklahoma | 73120 | United States |
|
| Lancaster General Hospital | Recruiting | Lancaster | Pennsylvania | 17602 | United States |
|
| University of Pennsylvania, Penn Presbyterian Medical Center | Recruiting | Philadelphia | Pennsylvania | 19104 | United States |
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| Allegheny Health Network | Recruiting | Pittsburgh | Pennsylvania | 15222 | United States |
|
| WellSpan Health | Recruiting | York | Pennsylvania | 17403 | United States |
|
| Upstate Cardiology | Recruiting | Greenville | South Carolina | 29607 | United States |
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| Carolina Cardiology Associates and OnSite Clinical Solutions | Terminated | Rock Hill | South Carolina | 29732 | United States |
| Baylor Scott & White Research Institute | Recruiting | Dallas | Texas | 75204 | United States |
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| Medical City Dallas Hospital | Recruiting | Dallas | Texas | 75320 | United States |
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| St. Mark's Hospital | Recruiting | Salt Lake City | Utah | 84124 | United States |
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| Centra Health, Inc. dba Stroobants Cardiovascular Center | Recruiting | Lynchburg | Virginia | 24501 | United States |
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| Bon Secours St. Marys | Recruiting | Midlothian | Virginia | 23114 | United States |
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| CJW Medical Center | Recruiting | Richmond | Virginia | 23261 | United States |
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| Valley Health | Recruiting | Winchester | Virginia | 22601 | United States |
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| MultiCare Institute for Research & Innovation | Recruiting | Tacoma | Washington | 98405 | United States |
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| MercyHealth | Recruiting | Janesville | Wisconsin | 53548 | United States |
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| University of Wisconsin | Recruiting | Madison | Wisconsin | 53792 | United States |
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| Alberta Health | Recruiting | Edmonton | Alberta | T6G2B7 | Canada |
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| Southlake Regional Health Centre | Recruiting | Newmarket | Ontario | L3Y2P6 | Canada |
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| Background |
| Kreidieh O, Varley AL, Romero J, Singh D, Silverstein J, Thosani A, Varosy P, Hebsur S, Godfrey BE, Schrappe G, Justice L, Zei PC, Osorio J. Practice Patterns of Operators Participating in the Real-World Experience of Catheter Ablation for Treatment of Symptomatic Paroxysmal and Persistent Atrial Fibrillation (REAL-AF) Registry. J Interv Card Electrophysiol. 2022 Nov;65(2):429-440. doi: 10.1007/s10840-022-01205-0. Epub 2022 Apr 19. |
| 34212280 | Background | Varley AL, Kreidieh O, Godfrey BE, Whitmire C, Thorington S, D'Souza B, Kang S, Hebsur S, Ravindran BK, Zishiri E, Gidney B, Sellers MB, Singh D, Salam T, Metzl M, Ro A, Nazari J, Fisher WG, Costea A, Magnano A, Oza S, Morales G, Rajendra A, Silverstein J, Zei PC, Osorio J. A prospective multi-site registry of real-world experience of catheter ablation for treatment of symptomatic paroxysmal and persistent atrial fibrillation (Real-AF): design and objectives. J Interv Card Electrophysiol. 2021 Dec;62(3):487-494. doi: 10.1007/s10840-021-01031-w. Epub 2021 Jul 2. |
| 38768839 | Result | Osorio J, Miranda-Arboleda AF, Velasco A, Varley AL, Rajendra A, Morales GX, Hoyos C, Matos C, Thorne C, D'Souza B, Silverstein JR, Metzl MD, Hebsur S, Costea AI, Kang S, Sellers M, Singh D, Salam T, Nazari J, Ro AS, Mazer S, Moretta A, Oza SR, Magnano AR, Sackett M, Dukes J, Patel P, Goyal SK, Senn T, Newton D, Romero JE, Zei PC; REAL-AF Investigators. Real-world data of radiofrequency catheter ablation in paroxysmal atrial fibrillation: Short- and long-term clinical outcomes from the prospective multicenter REAL-AF Registry. Heart Rhythm. 2024 Nov;21(11):2083-2091. doi: 10.1016/j.hrthm.2024.04.090. Epub 2024 May 19. |
| 38282445 | Result | Kreidieh O, Hunter TD, Goyal S, Varley AL, Thorne C, Osorio J, Silverstein J, Varosy P, Metzl M, Leyton-Mange J, Singh D, Rajendra A, Moretta A, Zei PC; Investigators of the REAL AF registry. Predictors of first pass isolation of the pulmonary veins in real world ablations: An analysis of 2671 patients from the REAL-AF registry. J Cardiovasc Electrophysiol. 2024 Mar;35(3):440-450. doi: 10.1111/jce.16190. Epub 2024 Jan 28. |
| 37804258 | Result | Costea A, Diaz JC, Osorio J, Matos CD, Hoyos C, Goyal S, Te C, D'Souza B, Rastogi M, Lopez-Cabanillas N, Ibanez LC, Thorne C, Varley AL, Zei PC, Sauer WH, Romero JE. 50-W vs 40-W During High-Power Short-Duration Ablation for Paroxysmal Atrial Fibrillation: A Multicenter Prospective Study. JACC Clin Electrophysiol. 2023 Dec;9(12):2573-2583. doi: 10.1016/j.jacep.2023.08.005. Epub 2023 Oct 4. |
| 37294263 | Result | Osorio J, Zei PC, Diaz JC, Varley AL, Morales GX, Silverstein JR, Oza SR, D'Souza B, Singh D, Moretta A, Metzl MD, Hoyos C, Matos CD, Rivera E, Magnano A, Salam T, Nazari J, Thorne C, Costea A, Thosani A, Rajendra A, Romero JE. High-Frequency Low-Tidal Volume Ventilation Improves Long-Term Outcomes in AF Ablation: A Multicenter Prospective Study. JACC Clin Electrophysiol. 2023 Aug;9(8 Pt 2):1543-1554. doi: 10.1016/j.jacep.2023.05.015. Epub 2023 May 18. |
| 37204358 | Result | Rajendra A, Osorio J, Diaz JC, Hoyos C, Rivera E, Matos CD, Costea A, Varley AL, Thorne C, Hoskins M, Goyal S, Oza S, Magnano A, D'Souza B, Silverstein J, Metzl M, Zei PC, Romero JE. Performance of the REAL-AF Same-Day Discharge Protocol in Patients Undergoing Catheter Ablation of Atrial Fibrillation. JACC Clin Electrophysiol. 2023 Aug;9(8 Pt 2):1515-1526. doi: 10.1016/j.jacep.2023.04.014. Epub 2023 May 18. |
| 35947317 | Result | Rajendra A, Hunter TD, Morales GX, Zei P, Boo LM, Varley A, Osorio J. Steerable sheath visualizable under 3D electroanatomical mapping facilitates paroxysmal atrial fibrillation ablation with minimal fluoroscopy. J Interv Card Electrophysiol. 2023 Mar;66(2):381-388. doi: 10.1007/s10840-022-01332-8. Epub 2022 Aug 10. |
| 35333095 | Result | Osorio J, Varley A, Kreidieh O, Godfrey B, Schrappe G, Rajendra A, Silverstein J, Romero J, Rodriguez D, Morales G, Zei P. High-Frequency, Low-Tidal-Volume Mechanical Ventilation Safely Improves Catheter Stability and Procedural Efficiency During Radiofrequency Ablation of Atrial Fibrillation. Circ Arrhythm Electrophysiol. 2022 Apr;15(4):e010722. doi: 10.1161/CIRCEP.121.010722. Epub 2022 Mar 25. No abstract available. |
| 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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