Clinical trial NCT05242250: Real-World Evidence Registry to Assess Outcomes of Catheter Ablation for Atrial Fibrillation (DYNAMIC AF Registry)
Official title: A Multi-Center, Real-World Evidence Registry to Assess Outcomes for the Long-Term Impact of Catheter Ablation for Atrial Fibrillation: DYNAMIC AF Registry
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Atrial Fibrillation
Keywords: paroxysmal atrial fibrillation
atrial fibrillation ablation
catheter ablation
persistent atrial fibrillation
Lead sponsor: Heart Rhythm Clinical and Research Solutions, LLC
Sponsor class: OTHER
Collaborators: name: Abbott
First posted: 2022-02-16
Enrollment: 392
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients presenting at participating sites for atrial fibrillation ablation that meet all inclusion criteria.

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 (PAF) and persistent (PsAF) atrial fibrillation ablation. Patient assessments will occur at pre- procedure, procedure, 12 weeks, 6 months and 1 year post ablation.

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. 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.

Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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

Primary outcomes:
measure: Long term safety
timeFrame: 12 months
measure: Long term effectiveness (paroxysmal)
timeFrame: 12 months
measure: Long term effectiveness (persistent)
timeFrame: 12 months
measure: Procedural efficiency
timeFrame: Immediately after procedure
Secondary outcomes:
measure: Acute success
timeFrame: Immediately after procedure
measure: Patient-reported Outcome
timeFrame: 12 months
measure: Acute safety
timeFrame: 7 days
measure: Acute safety
timeFrame: 30 days
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Grandview Medical Center
state: Alabama
city: Annapolis
country: United States
facility: Luminis Health Anne Arundel Medical Center
state: Maryland
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
city: Philadelphia
country: United States
facility: Penn Presbyterian Hospital
state: Pennsylvania
Study officials:
affiliation: Grandview Medical Center
name: Jose Osorio, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Brigham and Women's Hospital
name: Paul Zei, PhD, MD
role: PRINCIPAL_INVESTIGATOR
References: