One More Magnetic Resonance Imaging

NCT02293070 | Completed

• 1 other identifier: 13-104
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this study is to utilize delayed enhanced cardiac magnetic resonance imaging to assess the success of pulmonary vein isolation after cryoablation of paroxysmal atrial fibrillation. The primary hypothesis is that cardiac magnetic resonance imaging will be able to visualize changes in left atrial tissue characteristics caused by cryoablation used to treat paroxysmal atrial fibrillation.

Conditions

Atrial Fibrillation

Outcome Measures

Primary Outcomes (1)

• Visualization of late gadolinium enhancement in the pulmonary veins on cardiac MRI

  The signal intensity of late gadolinium enhancement in the pulmonary vein region as measured on a cardiac MRI, in comparison to the signal intensity of the blood pool

  2-6 weeks after ablation

Secondary Outcomes (1)

• Recurrence of atrial fibrillation

  3-6 months after ablation

Study Arms (1)

Repeat Cardiac MRI Post Cryoablation

EXPERIMENTAL

All subjects in this study receive a follow up delayed enhanced cardiac MRI 2-6 weeks after they undergo a cryoablation procedure.

Other: Delayed Enhanced Cardiac Magnetic Resonance Imaging; Procedure: Cryoablation

Interventions

Delayed Enhanced Cardiac Magnetic Resonance Imaging OTHER

Subjects in this study get a Delayed Enhanced Cardiac Magnetic Resonance Imaging 2-6 weeks after they undergo cryoablation for atrial fibrillation. This MRI is compared to the pre-procedure cardiac MRI to determine if it possible to visualize the cryoablation lesions.

Also known as: Delayed Enhanced Cardiac MRI

Repeat Cardiac MRI Post Cryoablation

Cryoablation PROCEDURE

All subjects in this study undergo a cryoballoon ablation procedure to achieve pulmonary vein isolation for the purposes of treatment of atrial fibrillation

Also known as: Cryoballoon Ablation

Repeat Cardiac MRI Post Cryoablation

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \> 18 years and \< 80 years
• A diagnosis of symptomatic paroxysmal atrial fibrillation refractory to medical therapy and planned to undergo a cryoablation procedure.

You may not qualify if:

• Unable or unwilling to undergo magnetic resonance imaging (including implanted metal prosthesis, severe claustrophobia and inability to tolerate sedation)
• Previous atrial fibrillation ablation
• Patients who are not candidates for cryoablation procedure for treatment of atrial fibrillation

Sponsors & Collaborators

• Saint Luke's Health System: lead

Study Sites (1)

Saint Luke's Hospital

Kansas City, Missouri, 64111, United States

Location

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Cryosurgery

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Ablation Techniques; Surgical Procedures, Operative

Study Officials

• Sanjaya Gupta, MD

  Saint Luke's Health System

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 10, 2014
• First Posted: November 18, 2014
• Study Start: December 1, 2013
• Primary Completion: January 1, 2017
• Study Completion: January 1, 2017
• Last Updated: March 1, 2017

Record last verified: 2017-02

Locations

US (1)