A Pilot Investigation Detecting Cryoablation Scar by 3D Late Gadolinium Enhancement

Atrial Fibrillation Clinical Trial

— LAMDE  

Official title:

A Pilot Investigation Detecting Cryoablation Scar by 3D Late Gadolinium

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02875730
• Other study ID #: 16-044
• Status: Completed
• Phase: Phase 4
• Start date: December 13, 2016
• Est. completion date: April 27, 2018

Study information

• Verified date: June 2018
• Source: Aspire Foundation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a prospective trial investigating the effectiveness of a modified MRI preparatory pulse sequence to improve pulmonary vein isolation visualization.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: April 27, 2018
• Est. primary completion date: March 6, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Men or non-pregnant women

• A diagnosis of symptomatic paroxysmal or recently persistent atrial fibrillation with a documented successful cardioversion within 4 months of the procedure

• Documented treatment failure or intolerance of at least 1 anti-arrhythmic medication used to control atrial fibrillation.

Exclusion Criteria:

• Contraindication to MRI, such as implanted incompatible metal prosthesis, or subject size exceeds bore or table limits

• Allergy to gadolinium-based contrast agent

• Previous atrial fibrillation ablation

• Renal dysfunction (estimated GFR <60 mL/min/1.73m2) within 6 months

• Unwilling to provide informed consent for this protocol

Related Conditions & MeSH terms

• Atrial Fibrillation
• Cryoablation

Intervention

Procedure:
• Pulse Sequence
Cylindrical Navigator Preparatory Pulse Sequence
• CMRI
Cardiac Magnetic Resonance Imaging

Locations

Country	Name	City	State
United States	Saint Luke's Health System	Kansas City	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Aspire Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blood Pool Corrected Signal Intensity		Through study completion, an average of 1 year
Primary	Imaging Failure Rate		Through study completion, an average of 1 year
Primary	Extent of Detected LGE Signal Correlate to the Respiratory Navigator Scheme		Through study completion, an average of 1 year