High-resolution MRI of Atrial Fibrillation Patients Prior to Focal Impulse and Rotor Modulation (FIRM) Ablation

NCT03444337 | Unknown FDA Device

• 1 other identifier: 2016H0200
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Patients undergoing FIRM guided ablation of atrial fibrillation will undergo high resolution MRI imaging to determine correlation of underlying anatomic fibrotic regions with FIRM targeted sites for ablation.

Conditions

Atrial Fibrillation

Keywords

ablation; atrial fibrillation; FIRM

Outcome Measures

Primary Outcomes (1)

• Correlation of FIRM targeted sites with MRI fibrotic regions

  The primary endpoint of this study will be the presence or absence of a correlation between micro-anatomic fibrotic tracks of reentry, determined by a combination of atrial wall thickness, and local scar and fibrosis, and sites of FIRM map indicated rotor activity.

  Immediate post-procedure analysis

Secondary Outcomes (4)

• Success or failure of electrical isolation of PV

  Immediate post-procedure

• Termination of AF or significant slowing of AF

  Immediate post-procedure

• Correlation of recurrence of AF six months post ablation with percentage of fibrosis ablated

  Six months post ablation

• e. Correlation of absence atrial tachycardia or atrial flutter 6 months post ablation with connection of FIRM sites to areas of fibrotic scar or anatomic barriers.

  Six months post-ablation

Study Arms (1)

Catheter Ablation Group

Patients undergoing FIRM guided ablation of paroxysmal or persistent atrial fibrillation with pre-procedure high resolution cardiac MRI

Device: Catheter Ablation

Interventions

Catheter Ablation DEVICE

Catheter Ablation Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with symptomatic paroxysmal or persistent atrial fibrillation undergoing clinically-indicated ablation procedure employing FIRM mapping with pre-operative MRI

You may qualify if:

• Patients with symptomatic paroxysmal or persistent atrial fibrillation undergoing clinically-indicated ablation procedure employing FIRM mapping with pre-operative MRI.
• Subjects must be at least 18 years of age.

You may not qualify if:

• LAA thrombus present on pre-procedure TEE
• Unable to undergo MRI imaging
• Unable to receive gadolinium contrast.

Sponsors & Collaborators

• Ohio State University: lead

Study Sites (1)

Ohio State University

Columbus, Ohio, 43210, United States

RECRUITING

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

• Deanna Golden-Kreutz, RN, Phd

  Ohio State University

  STUDY DIRECTOR

Central Study Contacts

Adrianne Miller, RN

CONTACT

614-685-4394; Adrianne.Miller@osumc.edu

Julie Ryan, RN

CONTACT

614-685-4394; julie.ryan@osumc.edu

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Internal Medicine

Study Record Dates

• First Submitted: February 18, 2018
• First Posted: February 23, 2018
• Study Start: November 3, 2016
• Primary Completion: December 30, 2024
• Study Completion: December 30, 2024
• Last Updated: March 6, 2024

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)