Real-World Evidence Registry to Assess Outcomes of Catheter Ablation for Atrial Fibrillation (DYNAMIC AF Registry)

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

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.

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

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.

Connect with a study center

  • Grandview Medical Center

    Birmingham, Alabama 35243
    United States

    Site Not Available

  • Luminis Health Anne Arundel Medical Center

    Annapolis, Maryland 21401
    United States

    Site Not Available

  • Brigham and Women's Hospital

    Boston, Massachusetts 02115
    United States

    Site Not Available

  • Penn Presbyterian Hospital

    Philadelphia, Pennsylvania 19104
    United States

    Site Not Available

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