DYNAMIC AF is an observational, prospective, multi-center, non-randomized registry designed to obtain real world clinical experience of radiofrequency (RF) ablation for the treatment of paroxysmal (PAF) and persistent (PsAF) atrial fibrillation ablation. Patient assessments will occur at pre- procedure, procedure, 12 weeks, 6 months and 1 year post ablation.
Dynamic AF is a prospective, observational, multi-center, non-randomized registry designed to obtain real world clinical experience associated with the use of Abbott technologies for AF ablation. Future technologies may be included as they become available in the market. The registry population will include patients with symptomatic PAF or PsAF that meet all eligibility criteria, who, in the opinion of the investigator, are candidates for AF ablation. All patients will be treated with commercially approved catheters and the ablation procedure will be conducted based on the current standard of care. Participation in the registry does not influence treatment decisions. All consecutive patients presenting at the institution considered for an RF ablation procedure for symptomatic PAF or PsAF should be screened by the investigator or designated member of the research team for study eligibility The primary purpose of this registry is to assess procedural efficiencies as well as long term procedural safety and effectiveness of RF ablation in the treatment of patients with paroxysmal or persistent atrial fibrillation. The registry will utilize real world clinical data obtained from the use of commercially available technologies under the authority of a health care practitioner within a legitimate practitioner-patient relationship. To support the objective of the registry, both patient information and procedure data will be collected. Patient-related data will be collected at a pre ablation office visit, a 12-week post ablation office visit, interim arrhythmia recurrence monitoring at 6- and 12-month post ablation and a 12-month post ablation office visit. Procedure related data collection will include procedural workflow and acute, mid and late onset procedure or device related complications.
Study Type
OBSERVATIONAL
Enrollment
392
Ablation RF technologies manufactured by Abbott.
Grandview Medical Center
Birmingham, Alabama, United States
Luminis Health Anne Arundel Medical Center
Annapolis, Maryland, United States
Brigham and Women's Hospital
Boston, Massachusetts, United States
Penn Presbyterian Hospital
Philadelphia, Pennsylvania, United States
Long term safety
Long term safety is assessed by collection of procedure or device related complications.
Time frame: 12 months
Long term effectiveness (paroxysmal)
Freedom from atrial arrhythmias (atrial fibrillation/atrial flutter/atrial tachycardia) recurrence (documented episodes greater than 30 seconds) at 12-month follow-up.
Time frame: 12 months
Long term effectiveness (persistent)
Freedom from symptomatic atrial arrhythmia (atrial fibrillation/atrial flutter/atrial tachycardia) recurrence (documented episodes greater than 30 seconds) at 12-month follow-up
Time frame: 12 months
Procedural efficiency
Procedure time, ablation time, fluoroscopy time
Time frame: Immediately after procedure
Acute success
Termination of clinical arrhythmia, defined by termination to sinus rhythm or non-inducibility of clinical arrhythmia after ablation (cardioversion allowed prior to inducibility attempt)
Time frame: Immediately after procedure
Patient-reported Outcome
Assessed with 3 items-- How do you feel now compared to pre-ablation: 1) at rest; 2) during mild exercise; and 3) during rigorous exercise
Time frame: 12 months
Acute safety
Assessed by collection of procedure or device related complications that occur within 7 days of the ablation procedure
Time frame: 7 days
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Acute safety
Assessed by collection of peri-procedural complications that occur greater than 7 days but within 30 days post ablation.
Time frame: 30 days