NCT00745706

Brief Summary

Atrial Fibrillation (AF) is a common heart rhythm problem that can be eliminated by a radiofrequency ablation procedure. The purpose of this study is to assess the amount of AF that occurs before and after an ablation procedure associated with symptoms versus AF that is not associated with any symptoms. This study will confirm whether patients' symptoms or lack of symptoms post-ablation correlate well with actual episodes of Atrial Fibrillation. This is important information for physicians to know as it will help guide patient care post-ablation in the future. Information on patients' AF episodes will be collected by an implantable loop recorder (ILR) which will be implanted in all study patients 3 months prior to their AF ablation procedure. The ILR will automatically collect information on detected AF episodes while patients will records any symptoms related to AF episodes in study diaries.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at below P25 for not_applicable atrial-fibrillation

Timeline
Completed

Started Sep 2008

Longer than P75 for not_applicable atrial-fibrillation

Geographic Reach
1 country

8 active sites

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

Study Start

First participant enrolled

September 1, 2008

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

September 2, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 3, 2008

Completed
5.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2014

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

October 2, 2019

Status Verified

September 1, 2019

Enrollment Period

5.6 years

First QC Date

September 2, 2008

Last Update Submit

September 30, 2019

Conditions

Atrial Fibrillation

Outcome Measures

Primary Outcomes (3)

  • Incidence of asymptomatic versus symptomatic AF pre-ablation

    3 months

  • Incidence of asymptomatic versus symptomatic AF recurrence > 3months post-AF ablation in patients with "success" after ablation.

    30 months

  • Incidence of asymptomatic versus symptomatic AF recurrence > 3 months post-AF ablation in patients with "failure" after ablation

    30 months

Secondary Outcomes (5)

  • Incidence of peri-procedural and post-procedural embolic events

    24 hours

  • Correlation of early recurrences (<3 months post-ablation) to late recurrences (> 3 months post-ablation)

    3-30 months

  • Incidence of very late AF recurrence (beyond 12 months psot-ablation) in "successful" patients post-ablation (determined both by AF episodes and burden)

    30 months

  • Comparison of "success" and "failure" rates as determined by ILR versus traditional, clinically-indicated ECG and holter monitoring

    30 months

  • Cost-effectiveness analysis of using ILR monitoring for post-AF ablation monitoring versus traditional follow-up (ECGs, holter, loop recorders)

    30 months

Study Arms (1)

A

OTHER

Implantable Loop Recorder (ILR) implant

Device: Implantable Loop Recorder (ILR)

Interventions

Implantable Loop Recorder (ILR)DEVICE

Insertion of ILR 3 months prior to clinical ablation procedure to collect data on actual Atrial Fibrillation episodes and correlation with patient symptoms through patient diary entry. Then patient undergoes their previously indicated clinical ablation procedure and is then followed up with ILR insitu for 30 months post-ablation for the same as mentioned above.

Also known as: Reveal XT
A

Eligibility Criteria

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

You may qualify if:

  • Age \> 18 years old.
  • First-time ablation procedure for AF.
  • Symptomatic AF which has been refractory to at least one antiarrhythmic medication. "Symptomatic" patients should be patients who feel that they are aware of when they are in or out of AF. Symptoms may include palpitations, shortness of breath, chest pain, fatigue, or other symptoms, or any combination of the symptoms listed above.
  • Patients must have paroxysmal or persistent AF. Paroxysmal patients should have had at least 4 episodes of AF in the 6 months prior to assessment/ablation. Paroxysmal AF is defined as AF which spontaneously terminates within 7 days. Persistent AF is defined as AF which sustains for longer than 7 days, or AF lasting less than 7 days which requires either pharmacologic or electrical cardioversion.
  • No contraindication to systemic anticoagulation with heparin or coumadin.
  • Patients must be able and willing to provide written informed consent to participate in the study.

You may not qualify if:

  • Patients with permanent atrial fibrillation. Permanent AF is defined as chronic, persisting AF (typically more than 1 year) for which cardioversion (pharmacologic or electrical) has failed or will never be attempted.
  • Patients with AF felt to be secondary to an obvious reversible cause.
  • Patients with contraindications to systemic anticoagulation with heparin or coumadin.
  • Patients who have previously undergone atrial fibrillation ablation.
  • Patients who are or may potentially be pregnant.
  • Left atrial size \> or equal to 55 mm.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Victoria Cardiac Arrhythmia Trials Inc.

Victoria, British Columbia, V8R 4R2, Canada

Location

QEII Health Sciences Centre

Halifax, Nova Scotia, B3H 3A7, Canada

Location

Hamilton Health Sciences Centre

Hamilton, Ontario, L8L 2X2, Canada

Location

London Health Sciences Centre

London, Ontario, N6A 4G5, Canada

Location

Southlake Regional Health Centre

Newmarket, Ontario, L3Y 2P9, Canada

Location

University of Ottawa Heart Institute

Ottawa, Ontario, K1Y 4W7, Canada

Location

Hôpital Général de Montréal-McGill

Montreal, Quebec, H3G 1A4, Canada

Location

Hôpital Laval

Québec, Quebec, G1V 4G5, Canada

Location

Related Publications (1)

  • Verma A, Champagne J, Sapp J, Essebag V, Novak P, Skanes A, Morillo CA, Khaykin Y, Birnie D. Discerning the incidence of symptomatic and asymptomatic episodes of atrial fibrillation before and after catheter ablation (DISCERN AF): a prospective, multicenter study. JAMA Intern Med. 2013 Jan 28;173(2):149-56. doi: 10.1001/jamainternmed.2013.1561.

    PMID: 23266597RESULT

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Atul Verma, M.D.

    Southlake Regional Health Centre

    PRINCIPAL INVESTIGATOR

  • David Birnie, M.D.

    Ottawa Heart Institute Research Corporation

    PRINCIPAL INVESTIGATOR

  • Paul Novak, M.D.

    Royal Jubilee Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D., Director of Arrythmia Service

Study Record Dates

First Submitted

September 2, 2008

First Posted

September 3, 2008

Study Start

September 1, 2008

Primary Completion

April 1, 2014

Study Completion

December 1, 2014

Last Updated

October 2, 2019

Record last verified: 2019-09

Locations

CA(8)