NCT05242250

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

A Multi-Center, Real-World Evidence Registry to Assess Outcomes for the Long-Term Impact of Catheter Ablation for Atrial Fibrillation: DYNAMIC AF Registry

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 392 (actual)
• Sponsor: Heart Rhythm Clinical and Research Solutions, LLC · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Atrial Fibrillation

Interventions

Type	Name	Description
DEVICE	Catheter Ablation	Ablation RF technologies manufactured by Abbott.

Timeline

• Start date: 2022-01-10
• Primary completion: 2023-12-31
• Completion: 2023-12-31
• First posted: 2022-02-16
• Last updated: 2024-01-12

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated device study