Real-world Experience of Catheter Ablation for the Treatment of Paroxysmal and Persistent Atrial Fibrillation

Paroxysmal Atrial Fibrillation Clinical Trial

— REAL-AF  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04088071
• Other study ID #: RAF
• Status: Recruiting
• Start date: January 1, 2018
• Est. completion date: December 31, 2027

Study information

• Verified date: February 2024
• Source: Heart Rhythm Clinical and Research Solutions, LLC
• Contact: Kim Harbin
• Phone: 1-256-591-0727
• Email: kharbin[@]hrcrs.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 15000
• Est. completion date: December 31, 2027
• Est. primary completion date: December 31, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation
• Paroxysmal Atrial Fibrillation
• Persistent Atrial Fibrillation

Intervention

Device:
• Catheter ablation
Ablation RF technologies (e.g., THERMOCOOL SMARTTOUCH®, THERMOCOOL SMARTTOUCH® SF).

Locations

Country	Name	City	State
United States	Lovelace Health System	Albuquerque	New Mexico
United States	Mission Hospital	Asheville	North Carolina
United States	Piedmont Healthcare	Atlanta	Georgia
United States	The Medical Center of Aurora	Aurora	Colorado
United States	Grandview Medical Center	Birmingham	Alabama
United States	University of Alabama at Birmingham	Birmingham	Alabama
United States	Brigham and Women's Hospital	Boston	Massachusetts
United States	Valley Heart Rhythm Specialists	Chandler	Arizona
United States	University of Cincinnati	Cincinnati	Ohio
United States	University of Missouri	Columbia	Missouri
United States	Mount Carmel Columbus Cardiology Consultants	Columbus	Ohio
United States	Medical City Dallas Hospital	Dallas	Texas
United States	Northshore University Health System	Evanston	Illinois
United States	Upstate Cardiology	Greenville	South Carolina
United States	Cardiovascular Associates of the Delaware Valley	Haddon Heights	New Jersey
United States	The Queen's Medical Center	Honolulu	Hawaii
United States	Ascension St. Vincent's Hospital	Indianapolis	Indiana
United States	Mississippi Baptist Medical Center	Jackson	Mississippi
United States	Ascension St. Vincent's	Jacksonville	Florida
United States	MercyHealth	Janesville	Wisconsin
United States	Arrhythmia Research Group	Jonesboro	Arkansas
United States	Lancaster General Hospital	Lancaster	Pennsylvania
United States	Capitol CArdiology	Lanham	Maryland
United States	McLaren Greater Lansing	Lansing	Michigan
United States	Sparrow Clinical Research	Lansing	Michigan
United States	Keck School of Medicine	Los Angeles	California
United States	Norton Heart Specialists	Louisville	Kentucky
United States	Centra Health, Inc. dba Stroobants Cardiovascular Center	Lynchburg	Virginia
United States	Bon Secours St. Marys	Midlothian	Virginia
United States	Cardiology Associates of Mobile	Mobile	Alabama
United States	Naples Community Hospital	Naples	Florida
United States	Oklahoma Heart Hospital	Oklahoma City	Oklahoma
United States	Ascension Sacred Heart	Pensacola	Florida
United States	University of Pennsylvania, Penn Presbyterian Medical Center	Philadelphia	Pennsylvania
United States	Allegheny Health Network	Pittsburgh	Pennsylvania
United States	Maine Medical Center	Portland	Maine
United States	Carolina Cardiology Associates and OnSite Clinical Solutions	Rock Hill	South Carolina
United States	St. Mark's Hospital	Salt Lake City	Utah
United States	Santa Barbara Cottage Hospital	Santa Barbara	California
United States	Sarasota Memorial Hospital	Sarasota	Florida
United States	Memorial Health University Medical Center	Savannah	Georgia
United States	CoxHealth	Springfield	Missouri
United States	Prairie Education and Research	Springfield	Illinois
United States	MultiCare Institute for Research & Innovation	Tacoma	Washington
United States	Community Memorial Hospital	Ventura	California
United States	University HealthCare Alliance	Walnut Creek	California
United States	Novant Health Forsyth Medical Center	Winston-Salem	North Carolina
United States	WellSpan Health	York	Pennsylvania
United States	Michigan Heart	Ypsilanti	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
Heart Rhythm Clinical and Research Solutions, LLC	Biosense Webster, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effectiveness at 90 days	Freedom from atrial arrhythmia recurrence at 90 days post procedure.	90 days
Primary	Effectiveness at 12 months	Freedom from atrial arrhythmia recurrence at 12 months post procedure.	12 months
Primary	Long-term Safety	Adverse events from post-procedure through the 12-month office visit date	Post-procedure, 3 months, and 12 months
Secondary	AF recurrence	Recurrence seen during monitoring with Dual/ CRT Pacer or ICD; Event Monitor; LinQ; Holter; EKG; TTE	12 months
Secondary	Post-procedure arrhythmia treatments	Treatments for AF post-procedure	12 months
Secondary	AF 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
Secondary	AAD Usage	Antiarrhythmic drug use (and type) post procedure and 12 months	12 months
Secondary	OAC usage	Oral anticoagulant use at 12 months and drug type	12 months
Secondary	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
Secondary	Patient reported outcome	How do you feel now compared to pre-ablation?	12 months