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

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.

Study Overview

• Status: Terminated
• Conditions: Atrial Fibrillation
• Intervention / Treatment: Device: Catheter 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.

• Study Type: Observational
• Enrollment (Actual): 392

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35243
      • Grandview Medical Center
  • Maryland
    • Annapolis, Maryland, United States, 21401
      • Luminis Health Anne Arundel Medical Center
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Brigham and Women's Hospital
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Penn Presbyterian Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients presenting at participating sites for atrial fibrillation ablation that meet all inclusion criteria.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Acute SOC Sites with Patients with paroxysmal or persistent atrial fibrillation; 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.	Device: Catheter Ablation; Ablation RF technologies manufactured by Abbott.; Other Names: Atrial Fibrillation Ablation
Symptomatic Monitoring SOC Sites with Patients with paroxysmal or persistent atrial fibrillation; 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.	Device: Catheter Ablation; Ablation RF technologies manufactured by Abbott.; Other Names: Atrial Fibrillation Ablation
Full Monitoring SOC Sites with Patients with paroxysmal or persistent atrial fibrillation; 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.	Device: Catheter Ablation; Ablation RF technologies manufactured by Abbott.; Other Names: Atrial Fibrillation Ablation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Long term safety	Long term safety is assessed by collection of procedure or device related complications.	12 months
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
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
Procedural efficiency	Procedure time, ablation time, fluoroscopy time	Immediately after procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
Acute safety	Assessed by collection of procedure or device related complications that occur within 7 days of the ablation procedure	7 days
Acute safety	Assessed by collection of peri-procedural complications that occur greater than 7 days but within 30 days post ablation.	30 days

Collaborators and Investigators

• Sponsor: Heart Rhythm Clinical and Research Solutions, LLC
• Collaborators: Abbott
• Investigators: Principal Investigator: Jose Osorio, MD, Grandview Medical Center; Principal Investigator: Paul Zei, PhD, MD, Brigham and Women's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 10, 2022
• Primary Completion (Actual): December 31, 2023
• Study Completion (Actual): December 31, 2023

Study Registration Dates

• First Submitted: January 12, 2022
• First Submitted That Met QC Criteria: February 6, 2022
• First Posted (Actual): February 16, 2022

Study Record Updates

• Last Update Posted (Actual): January 12, 2024
• Last Update Submitted That Met QC Criteria: January 10, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: catheter ablation; atrial fibrillation ablation; paroxysmal atrial fibrillation; persistent atrial fibrillation
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation
• Other Study ID Numbers: DYNAMIC AF

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes