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Atrial FibrillationDISCERN-AFNCT00745706

Discerning Symptomatic and Asymptomatic Episodes Pre and Post Radiofrequency Ablation of Atrial Fibrillation

A study testing Implantable Loop Recorder (ILR) in people with Atrial Fibrillation, run by Ottawa Heart Institute Research Corporation at 8 sites in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Atrial Fibrillation
What is being tested?
Implantable Loop Recorder (ILR)
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
8 sitesCanada
Study dates
Sep 2008to Dec 2014
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

8 sites in 1 country.

8 sites in 1 country

Canada8 sites

  • QEII Health Sciences Centre

    Halifax, Nova Scotia, B3H 3A7

  • Hamilton Health Sciences Centre

    Hamilton, Ontario, L8L 2X2

  • London Health Sciences Centre

    London, Ontario, N6A 4G5

  • Hôpital Général de Montréal-McGill

    Montreal, Quebec, H3G 1A4

  • Southlake Regional Health Centre

    Newmarket, Ontario, L3Y 2P9

  • University of Ottawa Heart Institute

    Ottawa, Ontario, K1Y 4W7

  • Hôpital Laval

    Québec, Quebec, G1V 4G5

  • Victoria Cardiac Arrhythmia Trials Inc.

    Victoria, British Columbia, V8R 4R2

Other trials in Canada

About this study

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.

Read the 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.

Being tested
Implantable Loop Recorder (ILR)
Medical subject headings
Atrial Fibrillation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Implantable Loop Recorder (ILR)Device

    Also called Reveal XT

    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.

Study groups in NCT00745706
Study groupRoleWhat they receive
AOtherImplantable Loop Recorder (ILR) implant
Receives: Device: Implantable Loop Recorder (ILR)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of asymptomatic versus symptomatic AF pre-ablation

    Measured: 3 months

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

    Measured: 30 months

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

    Measured: 30 months

Secondary outcomes (5)

  1. Incidence of peri-procedural and post-procedural embolic events

    Measured: 24 hours

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

    Measured: 3-30 months

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

    Measured: 30 months

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

    Measured: 30 months

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

    Measured: 30 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Sep 2008 (estimated)
  2. Study startSep 2008
  3. Primary completionApr 2014
  4. Study completionDec 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Diagnosis
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
50 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00745706
Sponsor's protocol ID
UOHI-01
Acronym
DISCERN-AF
Status last verified
Sep 2019
First submitted
2 Sep 2008
Last updated
2 Oct 2019
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 23266597

Questions about this trial

What is this clinical trial studying?

A study testing Implantable Loop Recorder (ILR) in people with Atrial Fibrillation, run by Ottawa Heart Institute Research Corporation at 8 sites in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of asymptomatic versus symptomatic AF pre-ablation (time frame: 3 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00745706, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2019.

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