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Discerning Symptomatic and Asymptomatic Episodes Pre and Post Radiofrequency Ablation of Atrial Fibrillation (DISCERN-AF)

Primary Purpose

Atrial Fibrillation

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Implantable Loop Recorder (ILR)
Sponsored by
Ottawa Heart Institute Research Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Atrial Fibrillation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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.
  • At least one episode of AF must have been documented by ECG or Holter within 12 months of inclusion in the study.
  • 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.

Exclusion Criteria:

  • 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.

Sites / Locations

  • Victoria Cardiac Arrhythmia Trials Inc.
  • QEII Health Sciences Centre
  • Hamilton Health Sciences Centre
  • London Health Sciences Centre
  • Southlake Regional Health Centre
  • University of Ottawa Heart Institute
  • Hôpital Général de Montréal-McGill
  • Hôpital Laval

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

A

Arm Description

Implantable Loop Recorder (ILR) implant

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Incidence of peri-procedural and post-procedural embolic events
Correlation of early recurrences (<3 months post-ablation) to late recurrences (> 3 months post-ablation)
Incidence of very late AF recurrence (beyond 12 months psot-ablation) in "successful" patients post-ablation (determined both by AF episodes and burden)
Comparison of "success" and "failure" rates as determined by ILR versus traditional, clinically-indicated ECG and holter monitoring
Cost-effectiveness analysis of using ILR monitoring for post-AF ablation monitoring versus traditional follow-up (ECGs, holter, loop recorders)

Full Information

First Posted
September 2, 2008
Last Updated
September 30, 2019
Sponsor
Ottawa Heart Institute Research Corporation
Collaborators
Medtronic
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1. Study Identification

Unique Protocol Identification Number
NCT00745706
Brief Title
Discerning Symptomatic and Asymptomatic Episodes Pre and Post Radiofrequency Ablation of Atrial Fibrillation
Acronym
DISCERN-AF
Official Title
Discerning Symptomatic and Asymptomatic Episodes Pre and Post Radiofrequency Ablation of Atrial Fibrillation
Study Type
Interventional

2. Study Status

Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
September 2008 (undefined)
Primary Completion Date
April 2014 (Actual)
Study Completion Date
December 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ottawa Heart Institute Research Corporation
Collaborators
Medtronic

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
Patients scheduled to undergo a first time ablation for AF will be implanted with an implantable loop recorder (ILR), capable of automatically recording episodes of AF, 3 months prior to their ablation procedure. Patients will also be given a standardized diary in which they will record all perceived episodes of AF. Patients will have the data from the ILR downloaded prior to their ablation to record baseline AF data. A blanking period of 3 months will be used to censor early recurrences post-ablation. A 'successful' AF ablation will be defined as a lack of AF episodes > 2min at least 3 months post-ablation. A 'Failure' AF ablation will encompass all patients not meeting the definition of 'success'. Redo ablation procedures will be allowed in this protocol for patients who continue to have AF recurrences beyond the first three months post-ablation. After the patient's ablation procedure, patients will be followed every 3 months for 18 months. At each follow-up visit data on AF episodes from the ILR and the patient diaries will be collected. Patients will be blinded to the data downloaded from the device. Further data will be collected as the patient study follow-up period has been extended to include a 30-month post-ablation visit with device interrogation as device battery is 36-42 months.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Other
Arm Description
Implantable Loop Recorder (ILR) implant
Intervention Type
Device
Intervention Name(s)
Implantable Loop Recorder (ILR)
Other Intervention Name(s)
Reveal XT
Intervention Description
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.
Primary Outcome Measure Information:
Title
Incidence of asymptomatic versus symptomatic AF pre-ablation
Time Frame
3 months
Title
Incidence of asymptomatic versus symptomatic AF recurrence > 3months post-AF ablation in patients with "success" after ablation.
Time Frame
30 months
Title
Incidence of asymptomatic versus symptomatic AF recurrence > 3 months post-AF ablation in patients with "failure" after ablation
Time Frame
30 months
Secondary Outcome Measure Information:
Title
Incidence of peri-procedural and post-procedural embolic events
Time Frame
24 hours
Title
Correlation of early recurrences (<3 months post-ablation) to late recurrences (> 3 months post-ablation)
Time Frame
3-30 months
Title
Incidence of very late AF recurrence (beyond 12 months psot-ablation) in "successful" patients post-ablation (determined both by AF episodes and burden)
Time Frame
30 months
Title
Comparison of "success" and "failure" rates as determined by ILR versus traditional, clinically-indicated ECG and holter monitoring
Time Frame
30 months
Title
Cost-effectiveness analysis of using ILR monitoring for post-AF ablation monitoring versus traditional follow-up (ECGs, holter, loop recorders)
Time Frame
30 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. At least one episode of AF must have been documented by ECG or Holter within 12 months of inclusion in the study. 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. Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Atul Verma, M.D.
Organizational Affiliation
Southlake Regional Health Centre
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
David Birnie, M.D.
Organizational Affiliation
Ottawa Heart Institute Research Corporation
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Paul Novak, M.D.
Organizational Affiliation
Royal Jubilee Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Victoria Cardiac Arrhythmia Trials Inc.
City
Victoria
State/Province
British Columbia
ZIP/Postal Code
V8R 4R2
Country
Canada
Facility Name
QEII Health Sciences Centre
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3H 3A7
Country
Canada
Facility Name
Hamilton Health Sciences Centre
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8L 2X2
Country
Canada
Facility Name
London Health Sciences Centre
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 4G5
Country
Canada
Facility Name
Southlake Regional Health Centre
City
Newmarket
State/Province
Ontario
ZIP/Postal Code
L3Y 2P9
Country
Canada
Facility Name
University of Ottawa Heart Institute
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1Y 4W7
Country
Canada
Facility Name
Hôpital Général de Montréal-McGill
City
Montréal
State/Province
Quebec
ZIP/Postal Code
H3G 1A4
Country
Canada
Facility Name
Hôpital Laval
City
Québec
State/Province
Quebec
ZIP/Postal Code
G1V 4G5
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
23266597
Citation
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.
Results Reference
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Discerning Symptomatic and Asymptomatic Episodes Pre and Post Radiofrequency Ablation of Atrial Fibrillation

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