Efficacy of Delayed Enhancement MRI-Guided Ablation vs Conventional Catheter Ablation of Atrial Fibrillation

NCT02529319 | Completed DMC

• 1 other identifier: IRB_00076945
• Study Type: interventional
• Target: 843
• Locations: 1 country
• Sites: 1

Brief Summary

This proposal is aiming at modifying and improving persistent AF management guidelines by evaluating targeting DE-MRI detected atrial fibrosis during AF ablation and its related effect on procedural outcome. OBJECTIVES: Primary Objective: To examine the efficacy of targeting atrial fibrosis tissue during an ablation procedure in treating persistent AF. Results from the DECAAF study show that one of the most important predictors of ablation outcome was the degree of ablation of the fibrotic tissue; the more fibrotic tissue that was overlapped with scar during ablation, the better the outcome. These results were the impetus for the primary outcome of DECAAF II. Patients will be randomized to receive conventional pulmonary vein isolation (PVI) ablation or PVI + fibrosis-guided ablation. The investigators will follow patients longitudinally to assess the primary outcome identified as recurrence of persistent atrial arrhythmias (AA) (atrial fibrillation, atrial flutter or atrial tachycardia as defined by recent guidelines \[2\]). The investigators hypothesize that patients receiving fibrosis-guided ablation in addition to conventional PVI ablation will have fewer AA recurrences than those who receive PVI ablation alone. The investigators will also examine the efficacy of the fibrosis-guided ablation intervention on a number of secondary or exploratory outcomes including the individual components of the primary outcome (atrial fibrillation, atrial flutter and atrial tachycardia), symptomatic atrial arrhythmia, AF cycle length/regularity/termination, cardiovascular (CV)-related hospitalization, CV-related mortality, quality of life measurements (University of Toronto Atrial Fibrillation Severity Scale (AFSS), and AF burden. The safety of the two interventions will be evaluated by evaluating peri-procedural complications including stroke, peripheral vascular stenosis, bleeding, esophageal injury, cardiac perforation, heart failure, and death.

Conditions

Atrial Fibrillation; Fibrosis

Keywords

atrial fibrillation; ablation

Outcome Measures

Primary Outcomes (1)

• AF Recurrence

  recurrence of 30 seconds of any atrial arrythmia as evidenced by a 45 second ECG strip.

  18 months

Study Arms (2)

MRI-Guided Ablation

EXPERIMENTAL

Surgery Patients will undergo catheter ablation using DE-MRI as a guide for fibrosis imaging.

Procedure: MRI-Guided Ablation

Conventional Ablation

ACTIVE COMPARATOR

Surgery Patients will undergo conventional catheter ablation as described by the HRS guidelines.

Procedure: Conventional Ablation

Interventions

MRI-Guided Ablation PROCEDURE

Catheter ablation of AF will be guided by a DE-MRI of the patient's heart prior to the procedure.

MRI-Guided Ablation

Conventional Ablation PROCEDURE

Catheter ablation of AF using pulmonary vein isolation (PVI) will be performed using the HRS guidelines.

Conventional Ablation

Eligibility Criteria

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

You may qualify if:

• Patients with persistent Atrial Fibrillation (AF) defined as 7 days or more of AF as evidence by rhythm strips or written documentation; AND
• Undergoing first AF ablation as per recent HRS consensus document; AND
• Age ≥ 18 years

You may not qualify if:

• Previous left atrial ablation or any type of valvular surgery; OR
• Contraindication for DE-MRI with a full dose contrast agent; OR
• Contraindication to beta blockers, if necessary, for DE-MRI; OR
• Women currently pregnant; OR
• Mental or physical inability to take part in the study; OR
• Inability to be placed in MRI due to body mass or body habitus; OR
• Known terminally ill patients; OR
• Subjects without daily access to a smart phone or tablet compatible with the ECG. Check application ability to upload ECG tracings for the entire follow up period.

Sponsors & Collaborators

• Tulane University School of Medicine: lead
• Tulane University: collaborator

Study Sites (1)

CARMA Center, University of Utah

Salt Lake City, Utah, 84132, United States

Location

Related Publications (2)

• Marrouche NF, Wazni O, McGann C, Greene T, Dean JM, Dagher L, Kholmovski E, Mansour M, Marchlinski F, Wilber D, Hindricks G, Mahnkopf C, Wells D, Jais P, Sanders P, Brachmann J, Bax JJ, Morrison-de Boer L, Deneke T, Calkins H, Sohns C, Akoum N; DECAAF II Investigators. Effect of MRI-Guided Fibrosis Ablation vs Conventional Catheter Ablation on Atrial Arrhythmia Recurrence in Patients With Persistent Atrial Fibrillation: The DECAAF II Randomized Clinical Trial. JAMA. 2022 Jun 21;327(23):2296-2305. doi: 10.1001/jama.2022.8831.

  PMID: 35727277 DERIVED

• Marrouche NF, Greene T, Dean JM, Kholmovski EG, Boer LM, Mansour M, Calkins H, Marchlinski F, Wilber D, Hindricks G, Mahnkopf C, Jais P, Sanders P, Brachmann J, Bax J, Dagher L, Wazni O, Akoum N; DECAAF II Investigators. Efficacy of LGE-MRI-guided fibrosis ablation versus conventional catheter ablation of atrial fibrillation: The DECAAF II trial: Study design. J Cardiovasc Electrophysiol. 2021 Apr;32(4):916-924. doi: 10.1111/jce.14957. Epub 2021 Mar 2.

  PMID: 33600025 DERIVED

MeSH Terms

Conditions

Atrial Fibrillation; Fibrosis

Condition Hierarchy (Ancestors)

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

Study Officials

• Nassir Marrouche, MD, FHRS

  Associate Professor

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 11, 2015
• First Posted: August 20, 2015
• Study Start: July 1, 2016
• Primary Completion: February 8, 2021
• Study Completion: April 21, 2021
• Last Updated: December 21, 2023

Record last verified: 2023-12

Locations

US (1)