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

Atrial Fibrillation Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT05242250
• Other study ID #: DYNAMIC AF
• Status: Terminated
• Start date: January 10, 2022
• Est. completion date: December 31, 2023

Study information

• Verified date: January 2024
• Source: Heart Rhythm Clinical and Research Solutions, LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 392
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Device:
• Catheter Ablation
Ablation RF technologies manufactured by Abbott.

Locations

Country	Name	City	State
United States	Luminis Health Anne Arundel Medical Center	Annapolis	Maryland
United States	Grandview Medical Center	Birmingham	Alabama
United States	Brigham and Women's Hospital	Boston	Massachusetts
United States	Penn Presbyterian Hospital	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Heart Rhythm Clinical and Research Solutions, LLC	Abbott

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Long term safety	Long term safety is assessed by collection of procedure or device related complications.	12 months
Primary	Long term effectiveness (paroxysmal)	Freedom from atrial arrhythmias (atrial fibrillation/atrial flutter/atrial tachycardia) recurrence (documented episodes greater than 30 seconds) at 12-month follow-up.	12 months
Primary	Long term effectiveness (persistent)	Freedom from symptomatic atrial arrhythmia (atrial fibrillation/atrial flutter/atrial tachycardia) recurrence (documented episodes greater than 30 seconds) at 12-month follow-up	12 months
Primary	Procedural efficiency	Procedure time, ablation time, fluoroscopy time	Immediately after procedure
Secondary	Acute success	Termination of clinical arrhythmia, defined by termination to sinus rhythm or non-inducibility of clinical arrhythmia after ablation (cardioversion allowed prior to inducibility attempt)	Immediately after procedure
Secondary	Patient-reported Outcome	Assessed with 3 items-- How do you feel now compared to pre-ablation: 1) at rest; 2) during mild exercise; and 3) during rigorous exercise	12 months
Secondary	Acute safety	Assessed by collection of procedure or device related complications that occur within 7 days of the ablation procedure	7 days
Secondary	Acute safety	Assessed by collection of peri-procedural complications that occur greater than 7 days but within 30 days post ablation.	30 days