Discerning Symptomatic and Asymptomatic Episodes Pre and Post Radiofrequency Ablation of Atrial Fibrillation (DISCERN-AF)
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.
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
|Official Title:||Discerning Symptomatic and Asymptomatic Episodes Pre and Post Radiofrequency Ablation of Atrial Fibrillation|
- 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 ]
- 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 ]
|Study Start Date:||September 2008|
|Estimated Study Completion Date:||December 2014|
|Primary Completion Date:||April 2014 (Final data collection date for primary outcome measure)|
Implantable Loop Recorder (ILR) implant
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
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00745706
|Canada, British Columbia|
|Victoria Cardiac Arrhythmia Trials Inc.|
|Victoria, British Columbia, Canada, V8R 4R2|
|Canada, Nova Scotia|
|QEII Health Sciences Centre|
|Halifax, Nova Scotia, Canada, B3H 3A7|
|Hamilton Health Sciences Centre|
|Hamilton, Ontario, Canada, L8L 2X2|
|London Health Sciences Centre|
|London, Ontario, Canada, N6A 4G5|
|Southlake Regional Health Centre|
|Newmarket, Ontario, Canada, L3Y 2P9|
|University of Ottawa Heart Institute|
|Ottawa, Ontario, Canada, K1Y 4W7|
|Hôpital Général de Montréal-McGill|
|Montréal, Quebec, Canada, H3G 1A4|
|Québec, Quebec, Canada, G1V 4G5|
|Principal Investigator:||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|