Brief Summary
The primary purpose of this registry is to obtain real-world clinical experience of Paroxysmal (PAF) and Persistent (PsAF) Atrial Fibrillation ablation radiofrequency (RF) technologies. Data from the registry will be used to assess clinical outcomes, including procedural efficiency, safety, and long-term, effectiveness of catheter ablation with novel RF technologies in PAF and PsAF patients.
Brief Title
Real-world Experience of Catheter Ablation for the Treatment of Paroxysmal and Persistent Atrial Fibrillation
Detailed Description
The REAL AF Registry is an observational, prospective, multi-center, non-randomized registry designed to obtain real-world clinical experience of Paroxysmal and Persistent ablation RF technologies (e.g., THERMOCOOL SMARTTOUCH®, THERMOCOOL SMARTTOUCH® SF). Future new contact force technologies may be included as they become available in the market. Patient assessments will occur at the following time points: 1) pre-ablation, 2) procedure, 3) 10-12 weeks, 4) 6 months (monitor only) and 5) 1 year post ablation.
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 atrial arrhythmia recurrence post 90 day blanking period, and 2) acute and late onset complications.
Sites selected for this registry will already have the following pre and post procedure assessments as part of their standard of care:
Patient assessments at the following time points: (1) pre-ablation or baseline, (2) procedure, (3) 10-12 weeks, (4) 6 months (monitor only) and (5) 1 year post ablation.
Pre ablation/baseline assessment should include: TTE (within 6 months of procedure), CHADS2Vasc, sleep apnea, AAD status, OAC, Medical and Arrhythmia History 10-12 Week Follow-Up Office Visit: Physician evaluation, AAD status, OAC usage, repeat TTE, and Arrhythmia Reoccurrence and Treatment Assessment Monitoring: 96-hour continuous heart rhythm monitor scheduled at 6 months and 12 months post ablation, with an event monitor ordered as needed for symptomatic arrhythmias.
12 Month Follow up Office Visit: Physician evaluation, AF Type, AF Monitoring method, Sleep apnea, Post-procedure arrhythmia treatments, AF related symptoms and QOL improvement, AAD and OAC usage, CHA2DS2VASC and Arrhythmia Reoccurrence and Treatment Assessment
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 atrial arrhythmia recurrence post 90 day blanking period, and 2) acute and late onset complications.
Sites selected for this registry will already have the following pre and post procedure assessments as part of their standard of care:
Patient assessments at the following time points: (1) pre-ablation or baseline, (2) procedure, (3) 10-12 weeks, (4) 6 months (monitor only) and (5) 1 year post ablation.
Pre ablation/baseline assessment should include: TTE (within 6 months of procedure), CHADS2Vasc, sleep apnea, AAD status, OAC, Medical and Arrhythmia History 10-12 Week Follow-Up Office Visit: Physician evaluation, AAD status, OAC usage, repeat TTE, and Arrhythmia Reoccurrence and Treatment Assessment Monitoring: 96-hour continuous heart rhythm monitor scheduled at 6 months and 12 months post ablation, with an event monitor ordered as needed for symptomatic arrhythmias.
12 Month Follow up Office Visit: Physician evaluation, AF Type, AF Monitoring method, Sleep apnea, Post-procedure arrhythmia treatments, AF related symptoms and QOL improvement, AAD and OAC usage, CHA2DS2VASC and Arrhythmia Reoccurrence and Treatment Assessment
Categories
Central Contacts
Central Contact Role
Contact
Central Contact Phone
1-256-591-0727
Central Contact Email
kharbin@hrcrs.com
Central Contact Role
Contact
Central Contact Email
josorio@hrcrs.com
Completion Date
Completion Date Type
Estimated
Conditions
Paroxysmal Atrial Fibrillation
Persistent Atrial Fibrillation
Eligibility Criteria
Inclusion Criteria:
* Symptomatic Paroxysmal (AF episode terminate spontaneously within 7 days) or Persistent (AF sustained beyond 7 days) who, in the opinion of the investigator, are candidates for ablation for AF
* 18 years of age or older
* De Novo ablation procedure unless it is a repeat for a patient whose index procedure is also in the registry
* Able and willing to participate in baseline and follow up evaluations for the full length of the registry
* 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's duration)
* Having a repeat ablation, unless the subject's index ablation procedure is also included in the registry
* In the opinion of the investigator, any known contraindication to an ablation procedure
* Symptomatic Paroxysmal (AF episode terminate spontaneously within 7 days) or Persistent (AF sustained beyond 7 days) who, in the opinion of the investigator, are candidates for ablation for AF
* 18 years of age or older
* De Novo ablation procedure unless it is a repeat for a patient whose index procedure is also in the registry
* Able and willing to participate in baseline and follow up evaluations for the full length of the registry
* 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's duration)
* Having a repeat ablation, unless the subject's index ablation procedure is also included in the registry
* In the opinion of the investigator, any known contraindication to an ablation procedure
Inclusion Criteria
Inclusion Criteria:
* Symptomatic Paroxysmal (AF episode terminate spontaneously within 7 days) or Persistent (AF sustained beyond 7 days) who, in the opinion of the investigator, are candidates for ablation for AF
* 18 years of age or older
* De Novo ablation procedure unless it is a repeat for a patient whose index procedure is also in the registry
* Able and willing to participate in baseline and follow up evaluations for the full length of the registry
* Willing and able to provide informed consent, if applicable
* Symptomatic Paroxysmal (AF episode terminate spontaneously within 7 days) or Persistent (AF sustained beyond 7 days) who, in the opinion of the investigator, are candidates for ablation for AF
* 18 years of age or older
* De Novo ablation procedure unless it is a repeat for a patient whose index procedure is also in the registry
* Able and willing to participate in baseline and follow up evaluations for the full length of the registry
* Willing and able to provide informed consent, if applicable
Gender
All
Gender Based
false
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Minimum Age
18 Years
NCT Id
NCT04088071
Org Class
Other
Org Full Name
Heart Rhythm Clinical and Research Solutions, LLC
Org Study Id
RAF
Overall Status
Recruiting
Primary Completion Date
Primary Completion Date Type
Estimated
Official Title
Real-world Experience of Catheter Ablation for the Treatment of Symptomatic ParoxysmaL and Persistent Atrial Fibrillation Using Novel CARTO Technologies: REAL AF Registry
Primary Outcomes
Outcome Description
Freedom from atrial arrhythmia recurrence at 90 days post procedure.
Outcome Measure
Effectiveness at 90 days
Outcome Time Frame
90 days
Outcome Description
Freedom from atrial arrhythmia recurrence at 12 months post procedure.
Outcome Measure
Effectiveness at 12 months
Outcome Time Frame
12 months
Outcome Description
Adverse events from post-procedure through the 12-month office visit date
Outcome Measure
Long-term Safety
Outcome Time Frame
Post-procedure, 3 months, and 12 months
Secondary Outcomes
Outcome Description
Recurrence seen during monitoring with Dual/ CRT Pacer or ICD; Event Monitor; LinQ; Holter; EKG; TTE
Outcome Time Frame
12 months
Outcome Measure
AF recurrence
Outcome Description
Treatments for AF post-procedure
Outcome Time Frame
12 months
Outcome Measure
Post-procedure arrhythmia treatments
Outcome Description
Presence of: weakness, fluttering, SOB, fatigue, dizziness, decrease in exercise tolerance, chest pain/pressure, heart racing/palpitations, and other (yes/no)
Outcome Time Frame
12 months
Outcome Measure
AF related symptoms
Outcome Description
Antiarrhythmic drug use (and type) post procedure and 12 months
Outcome Time Frame
12 months
Outcome Measure
AAD Usage
Outcome Description
Oral anticoagulant use at 12 months and drug type
Outcome Time Frame
12 months
Outcome Measure
OAC usage
Outcome Description
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.
Outcome Time Frame
12 months
Outcome Measure
CHA2DS2VASC
Outcome Description
How do you feel now compared to pre-ablation?
Outcome Time Frame
12 months
Outcome Measure
Patient reported outcome
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Actual
First Submit Date
First Submit QC Date
Study Population
Study population consists of adults age 18 years or older with symptomatic Paroxysmal and Persistent Atrial Fibrillation who are candidates for ablation.
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
999
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Luigi Dibiase
Investigator Email
ldibiase@montefiore.org
Investigator Phone
347-271-1637