NCT02875730

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for phase_4 atrial-fibrillation

Timeline
Completed

Started Dec 2016

Shorter than P25 for phase_4 atrial-fibrillation

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 16, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 23, 2016

Completed
4 months until next milestone

Study Start

First participant enrolled

December 13, 2016

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 6, 2018

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 27, 2018

Completed
Last Updated

June 29, 2018

Status Verified

June 1, 2018

Enrollment Period

1.2 years

First QC Date

August 16, 2016

Last Update Submit

June 27, 2018

Conditions

Atrial FibrillationCryoablation

Outcome Measures

Primary Outcomes (3)

  • Blood Pool Corrected Signal Intensity

    Through study completion, an average of 1 year

  • Imaging Failure Rate

    Through study completion, an average of 1 year

  • Extent of Detected LGE Signal Correlate to the Respiratory Navigator Scheme

    Through study completion, an average of 1 year

Study Arms (1)

CMRI Pulse Sequence

EXPERIMENTAL

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.

Procedure: Pulse SequenceProcedure: CMRI

Interventions

Pulse SequencePROCEDURE

Cylindrical Navigator Preparatory Pulse Sequence

CMRI Pulse Sequence
CMRIPROCEDURE

Cardiac Magnetic Resonance Imaging

CMRI Pulse Sequence

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Saint Luke's Health System

Kansas City, Missouri, 64111, United States

Location

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 16, 2016

First Posted

August 23, 2016

Study Start

December 13, 2016

Primary Completion

March 6, 2018

Study Completion

April 27, 2018

Last Updated

June 29, 2018

Record last verified: 2018-06

Data Sharing

IPD Sharing
Will not share

Locations

US(1)