Status:
TERMINATED
Real-World Evidence Registry to Assess Outcomes of Catheter Ablation for Atrial Fibrillation (DYNAMIC AF Registry)
Lead Sponsor:
Heart Rhythm Clinical and Research Solutions, LLC
Collaborating Sponsors:
Abbott
Conditions:
Atrial Fibrillation
Eligibility:
All Genders
18+ years
Brief Summary
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 (PA...
Detailed Description
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. Futu...
Eligibility Criteria
Inclusion
- Patients with symptomatic, refractory or intolerant to at least one Class I or III AAD, paroxysmal atrial fibrillation (AF episode terminating spontaneously within 7 days) or symptomatic, refractory or intolerant to at least one Class I or III AAD, persistent AF (continuous AF sustained beyond 7-days and less than 1-year) who, in the opinion of the investigator, are candidates for ablation for AF. Refusal to take AADs for any reason is considered intolerant for the purposes of this protocol.
- Plans to undergo an RF catheter ablation procedure using an ablation catheter manufactured by Abbott
- De Novo ablation unless it is a repeat procedure for a subject whose index procedure is also included in the registry
- 18 years of age or older
- Able and willing to participate in baseline and follow up evaluations for the full length of the registry
Exclusion
- Pregnant women
- Individual who cannot read or write, or those who cannot legally consent for themselves
- Participating in another clinical trial or has participated in a clinical trial within 30 days prior to screening that may interfere with this registry.
- Long-standing persistent AF (continuous AF sustained \>=1 year)
- Previous left atrial surgery for atrial fibrillation
- 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 or to any device or drug required for use during an ablation procedure as assessed by the investigator
Key Trial Info
Start Date :
January 10 2022
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 31 2023
Estimated Enrollment :
392 Patients enrolled
Trial Details
Trial ID
NCT05242250
Start Date
January 10 2022
End Date
December 31 2023
Last Update
January 12 2024
Active Locations (4)
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1
Grandview Medical Center
Birmingham, Alabama, United States, 35243
2
Luminis Health Anne Arundel Medical Center
Annapolis, Maryland, United States, 21401
3
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
4
Penn Presbyterian Hospital
Philadelphia, Pennsylvania, United States, 19104