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

NCT ID: NCT02875730

Last Updated: 2018-06-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-12-13

Study Completion Date

2018-04-27

Brief Summary

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

Detailed Description

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Conditions

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Atrial Fibrillation Cryoablation

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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CMRI Pulse Sequence

Patients will have late gadolinium cardiac magnetic resonance images of the individual pulmonary veins acquired with the standard and the cylindrical navigator preparatory pulse sequences for comparison.

Group Type EXPERIMENTAL

Pulse Sequence

Intervention Type PROCEDURE

Cylindrical Navigator Preparatory Pulse Sequence

CMRI

Intervention Type PROCEDURE

Cardiac Magnetic Resonance Imaging

Interventions

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Pulse Sequence

Cylindrical Navigator Preparatory Pulse Sequence

Intervention Type PROCEDURE

CMRI

Cardiac Magnetic Resonance Imaging

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Aspire Foundation

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Saint Luke's Health System

Kansas City, Missouri, United States

Site Status

Countries

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United States

Other Identifiers

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16-044

Identifier Type: -

Identifier Source: org_study_id