Real-world Experience of Catheter Ablation for the Treatment of Arrhythmias
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorHeart Rhythm Clinical and Research Solutions, LLC
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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
Documented ventricular arrhythmia appropriate for catheter ablation.
Trial population
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.
Trial design
Design model
Cohort
Time perspective
Other
Treatments tested in this trial
Catheter ablation
DeviceAblation 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.
Treatment groups
20,000 Participants
are divided into 2 treatment groupsGroup A: REAL AF1 intervention
Group B: CORE VA1 intervention
Trial outcomes
Primary outcomes
1
Effectiveness at 90 days
Freedom from arrhythmia recurrence at 90 days post procedure.
Time frame
90 days2
Effectiveness at 12 months
Freedom from subject reported arrhythmia recurrence through 12 months post procedure.
Time frame
12 months3
Long-term Safety
Incidence of late onset complications, 30 days post-ablation which are procedure and/or device related
Time frame
30 days post ablationSecondary outcomes
1
Arrhythmia recurrence
Recurrence seen during monitoring with Dual/ CRT Pacer or ICD; Event Monitor; LinQ; Holter; EKG; TTE
Time frame
12 months2
Post-procedure arrhythmia treatments
Treatments for arrhythmia post-procedure
Time frame
12 months3
Arrhythmia related symptoms
Presence of: weakness, fluttering, SOB, fatigue, dizziness, decrease in exercise tolerance, chest pain/pressure, heart racing/palpitations, and other (yes/no)
Time frame
12 months4
AAD Usage
Antiarrhythmic drug use (and type) post procedure and 12 months
Time frame
12 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Heart Rhythm Clinical and Research Solutions, LLC
Lead sponsor
Biosense Webster, Inc.
Collaborator
Source ClinicalTrials.gov