Last updated: January 10, 2024
Sponsor: Heart Rhythm Clinical and Research Solutions, LLC
Overall Status: Terminated
Phase
N/A
Condition
Arrhythmia
Atrial Fibrillation
Chest Pain
Treatment
Catheter Ablation
Clinical Study ID
NCT05242250
DYNAMIC AF
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Patients with symptomatic, refractory or intolerant to at least one Class I or IIIAAD, paroxysmal atrial fibrillation (AF episode terminating spontaneously within 7days) 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 theopinion of the investigator, are candidates for ablation for AF. Refusal to take AADsfor any reason is considered intolerant for the purposes of this protocol.
- Plans to undergo an RF catheter ablation procedure using an ablation cathetermanufactured by Abbott
- De Novo ablation unless it is a repeat procedure for a subject whose index procedureis also included in the registry
- 18 years of age or older
- Able and willing to participate in baseline and follow up evaluations for the fulllength of the registry
Exclusion
Exclusion Criteria:
- Pregnant women
- Individual who cannot read or write, or those who cannot legally consent forthemselves
- 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 alsoincluded in the registry
- In the opinion of the investigator, any known contraindication to an ablationprocedure or to any device or drug required for use during an ablation procedure asassessed by the investigator
Study Design
Total Participants: 392
Treatment Group(s): 1
Primary Treatment: Catheter Ablation
Phase:
Study Start date:
January 10, 2022
Estimated Completion Date:
December 31, 2023
Study Description
Connect with a study center
Grandview Medical Center
Birmingham, Alabama 35243
United StatesSite Not Available
Luminis Health Anne Arundel Medical Center
Annapolis, Maryland 21401
United StatesSite Not Available
Brigham and Women's Hospital
Boston, Massachusetts 02115
United StatesSite Not Available
Penn Presbyterian Hospital
Philadelphia, Pennsylvania 19104
United StatesSite Not Available
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