Real-world Experience of Catheter Ablation for the Treatment of Arrhythmias
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Catheter ablation.
- Who it may be relevant to
- Registry conditions: Paroxysmal Atrial Fibrillation, Persistent Atrial Fibrillation, Ventricular Arrhythmia. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, Canada
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Real-world Experience of Catheter Ablation for the Treatment of Arrhythmias Symptomatic Using Novel CARTO Technologies: REAL Registry
Overview
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 CARTO™ 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.
Detailed description
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.
Interventions
- Device Catheter ablation
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.
Primary outcome measures
- Effectiveness at 90 days [Time frame: 90 days]
- Effectiveness at 12 months [Time frame: 12 months]
- Long-term Safety [Time frame: 30 days post ablation]
Secondary outcome measures (7)
- Arrhythmia recurrence [Time frame: 12 months]
- Post-procedure arrhythmia treatments [Time frame: 12 months]
- Arrhythmia related symptoms [Time frame: 12 months]
- AAD Usage [Time frame: 12 months]
- OAC usage [Time frame: 12 months]
- CHA2DS2VASC [Time frame: 12 months]
- Patient reported outcome [Time frame: 12 months]
Eligibility criteria
REAL AF Cohort
Inclusion criteria
- Symptomatic PAF (AF episode terminate spontaneously within 7 days) or PsAF (AF sustained beyond 7 days, but less than 365 days) subjects who, in the opinion of the investigator, are candidates for catheter ablation.
- >18 years of age.
- Will be treated with Biosense Webster Inc. ablation technologies
- All AF ablations performed with BWI catheters are included. This includes repeat ablations where the index procedure was performed with a non-BWI catheter.
- Able and willing to participate in baseline and follow up evaluations
- Willing and able to provide informed consent, if applicable.
Exclusion criteria
- Enrolled in an investigational drug or device clinical trial, or any trial that dictates the treatment plan
- Long-standing persistent AF (AF greater than one year)
- In the opinion of the investigator, any known contraindication to an ablation procedure
CORE VA Cohort
Inclusion criteria
- Documented ventricular arrhythmia appropriate for catheter ablation.
- >18 years of age.
- Will be treated with Biosense Webster Inc. ablation technologies
- Able and willing to participate in baseline and follow up evaluations
- Willing and able to provide informed consent, if applicable.
Exclusion criteria
- Enrolled in an investigational drug or device clinical trial, or any trial that dictates the treatment plan.
- In the opinion of the investigator, any known contraindication to an ablation procedure.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 68 centers
- University of Alabama at Birmingham — Birmingham
- Grandview Medical Center — Birmingham
- Cardiology Associates of Mobile — Mobile
- Valley Heart Rhythm Specialists — Chandler
- Pima Heart and Vascular — Tucson
- Arrhythmia Research Group — Jonesboro
- Keck School of Medicine — Los Angeles
- Santa Barbara Cottage Hospital — Santa Barbara
- … and 60 more centers
Canada · 2 centers
- Alberta Health — Edmonton
- Southlake Regional Health Centre — Newmarket
Publications
- 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 PMID 37254771
- 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/s1 PMID 35438393
- 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 p PMID 34212280
- 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 a PMID 38768839
- 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 PMID 38282445
- 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. PMID 37804258
- 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):1543-1 PMID 37294263
- 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 20 PMID 37204358
Identifiers
NCT: NCT04088071 · RAF