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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Medtronic
Information provided by (Responsible Party):
David Birnie, University of Ottawa Heart Institute
ClinicalTrials.gov Identifier:
NCT00745706
First received: September 2, 2008
Last updated: August 19, 2014
Last verified: August 2014

September 2, 2008
August 19, 2014
September 2008
April 2014   (final data collection date for primary outcome measure)
  • Incidence of asymptomatic versus symptomatic AF pre-ablation [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Incidence of asymptomatic versus symptomatic AF recurrence > 3months post-AF ablation in patients with "success" after ablation. [ Time Frame: 30 months ] [ Designated as safety issue: No ]
  • Incidence of asymptomatic versus symptomatic AF recurrence > 3 months post-AF ablation in patients with "failure" after ablation [ Time Frame: 30 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00745706 on ClinicalTrials.gov Archive Site
  • Incidence of peri-procedural and post-procedural embolic events [ Time Frame: 24 hours ] [ Designated as safety issue: Yes ]
  • Correlation of early recurrences (<3 months post-ablation) to late recurrences (> 3 months post-ablation) [ Time Frame: 3-30 months ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Comparison of "success" and "failure" rates as determined by ILR versus traditional, clinically-indicated ECG and holter monitoring [ Time Frame: 30 months ] [ Designated as safety issue: No ]
  • Cost-effectiveness analysis of using ILR monitoring for post-AF ablation monitoring versus traditional follow-up (ECGs, holter, loop recorders) [ Time Frame: 30 months ] [ Designated as safety issue: No ]
  • Incidence of peri-procedural and post-procedural embolic events [ Time Frame: 24 hours ] [ Designated as safety issue: Yes ]
  • Correlation of early recurrences (<3 months post-ablation) to late recurrences (> 3 months post-ablation) [ Time Frame: 3-18 months ] [ Designated as safety issue: No ]
  • 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: 18 months ] [ Designated as safety issue: No ]
  • Comparison of "success" and "failure" rates as determined by ILR versus traditional, clinically-indicated ECG and holter monitoring [ Time Frame: 18 months ] [ Designated as safety issue: No ]
  • Cost-effectiveness analysis of using ILR monitoring for post-AF ablation monitoring versus traditional follow-up (ECGs, holter, loop recorders) [ Time Frame: 18 months ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Discerning Symptomatic and Asymptomatic Episodes Pre and Post Radiofrequency Ablation of Atrial Fibrillation
Discerning Symptomatic and Asymptomatic Episodes Pre and Post Radiofrequency Ablation of Atrial Fibrillation

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.

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.

Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Atrial Fibrillation
Device: Implantable Loop Recorder (ILR)
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.
Other Name: Reveal XT
A
Implantable Loop Recorder (ILR) implant
Intervention: Device: Implantable Loop Recorder (ILR)
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
50
December 2014
April 2014   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT00745706
UOHI-01
No
David Birnie, University of Ottawa Heart Institute
University of Ottawa Heart Institute
Medtronic
Principal Investigator: Atul Verma, M.D. Southlake Regional Health Centre
Principal Investigator: David Birnie, M.D. University of Ottawa Heart Institute
Principal Investigator: Paul Novak, M.D. Royal Jubilee Hospital
University of Ottawa Heart Institute
August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP