NCT04290559

Brief Summary

The primary objective of this study is to determine the atrial fibrillation burden reduction, or absolute atrial fibrillation burden, associated with improvement in quality of life in patients undergoing ablation of persistent atrial fibrillation.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2018

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

Study Start

First participant enrolled

September 10, 2018

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

February 11, 2020

Completed
20 days until next milestone

First Posted

Study publicly available on registry

March 2, 2020

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2021

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2022

Completed
Last Updated

March 31, 2020

Status Verified

March 1, 2020

Enrollment Period

3 years

First QC Date

February 11, 2020

Last Update Submit

March 29, 2020

Conditions

Atrial Fibrillation

Keywords

Catheter ablationQuality of lifeAtrial fibrillation burdenPersistent atrial fibrillation

Outcome Measures

Primary Outcomes (1)

  • AF burden correlated with change in QOL.

    AF burden change and absolute AF burden correlated with change in QOL mesured at 12 and 24 months after the AF ablation

    12 months, 24 months

Secondary Outcomes (4)

  • Freedom of atrial arrhythmia

    12 months, 24 months

  • Economic evaluation

    12 months, 24 months

  • Incidence of silent AF recurrences

    12 months, 24 months

  • Impact of antiarrhythmic treatment

    12 months

Interventions

Reveal LINQ ILR implant before AF ablationPROCEDURE

Patients will undergo insertion of a LINQ ILR before the atrial fibrillation ablation performed according to standard clinical practice.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with persistent or long-standing persistent atrial fibrillation and an AF burden of equal or more than 80%, referred for an atrial fibrillation catheter ablation.

You may qualify if:

  • Age \> 18 years
  • Patients undergoing first-time or redo AF ablation.
  • Persistent or long-standing persistent AF
  • Symptomatic atrial fibrillation
  • Willing and able to provide informed consent.
  • Willing and able to set up and utilize MyCareLink® home monitor and be remotely monitored
  • Atrial fibrillation burden equal or more than 80% prior to the ablation

You may not qualify if:

  • Paroxysmal AF
  • If the patient has had a cardioversion within 2 months of the ablation
  • Patients with contraindication to oral or intravenous anticoagulation.
  • Contraindication to implantation of an ILR

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Southlake Regional Health Centre

Newmarket, Ontario, L3Y2P9, Canada

RECRUITING

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Sherri Patterson, BScN

CONTACT

905-895-4521SPatterson@southlakeregional.org

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 11, 2020

First Posted

March 2, 2020

Study Start

September 10, 2018

Primary Completion

September 1, 2021

Study Completion

September 1, 2022

Last Updated

March 31, 2020

Record last verified: 2020-03

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)