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

NCT05242250 | Terminated DMC FDA Device

• 1 other identifier: DYNAMIC AF
• Study Type: observational
• Target: 392
• Locations: 1 country
• Sites: 4

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.

Conditions

Atrial Fibrillation

Keywords

paroxysmal atrial fibrillation; atrial fibrillation ablation; catheter ablation; persistent atrial fibrillation

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (4)

• Acute success

  Immediately after procedure

• Patient-reported Outcome

  12 months

• Acute safety

  7 days

• Acute safety

  30 days

Study Arms (3)

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

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

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

Interventions

Catheter Ablation DEVICE

Ablation RF technologies manufactured by Abbott.

Also known as: Atrial Fibrillation Ablation

Acute SOC Sites with Patients with paroxysmal or persistent atrial fibrillation; Full Monitoring SOC Sites with Patients with paroxysmal or persistent atrial fibrillation; Symptomatic Monitoring SOC Sites with Patients with paroxysmal or persistent atrial fibrillation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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
• years of age or older
• Able and willing to participate in baseline and follow up evaluations for the full length of the registry

You may not qualify if:

• 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

Sponsors & Collaborators

• Heart Rhythm Clinical and Research Solutions, LLC: lead
• Abbott: collaborator

Study Sites (4)

Grandview Medical Center

Birmingham, Alabama, 35243, United States

Location

Luminis Health Anne Arundel Medical Center

Annapolis, Maryland, 21401, United States

Location

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Penn Presbyterian Hospital

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Catheter Ablation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Radiofrequency Ablation; Radiofrequency Therapy; Therapeutics; Ablation Techniques; Surgical Procedures, Operative

Study Officials

• Jose Osorio, MD

  Grandview Medical Center

  PRINCIPAL INVESTIGATOR

• Paul Zei, PhD, MD

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 12, 2022
• First Posted: February 16, 2022
• Study Start: January 10, 2022
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: January 12, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)