Recruiting

Atrial Fibrillation Ablation

Sponsor:

Newmarket Electrophysiology Research Group Inc

Code:

NCT04290559

Conditions

Atrial Fibrillation

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Reveal LINQ ILR implant before AF ablation

Study Details

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.

Conditions

Atrial Fibrillation

Study ID

NCT04290559

Start date

Sep 10, 2018

Status verified date

Mar, 2020

Completion date

Sep, 2022

Anticipated

Primary completion date

Sep, 2021

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Design

Enrollment

200 participants

Anticipated

Interventions and Outcome Measures

Interventions

Reveal LINQ ILR implant before AF ablation

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

Primary outcome measure

  • AF burden correlated with change in QOL. [ Time Frame: 12 months, 24 months ]

Central Contacts and Locations

Central contacts

Sherri Patterson, BScN

905-895-4521SPatterson@southlakeregional.org

Locations

Southlake Regional Health Centre

Recruiting

Newmarket, Ontario, Canada, L3Y2P9

Contacts

Sherri Patterson, BScN

905-895-4521SPatterson@southlakeregional.org

More Information

Sponsor

Newmarket Electrophysiology Research Group Inc

Last update posted

Mar 31, 2020

Last verified

Mar, 2020

Keywords

  • Catheter ablation
  • Quality of life
  • Atrial fibrillation burden
  • Persistent atrial fibrillation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Newmarket Electrophysiology Research Group Inc on 2020-03-31.