Discerning Symptomatic and Asymptomatic Episodes Pre and Post Radiofrequency Ablation of Atrial Fibrillation (DISCERN-AF)
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| ClinicalTrials.gov Identifier: NCT00745706 |
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Recruitment Status :
Completed
First Posted : September 3, 2008
Last Update Posted : March 11, 2015
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Atrial Fibrillation | Device: Implantable Loop Recorder (ILR) | Not Applicable |
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.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 50 participants |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Diagnostic |
| Official Title: | Discerning Symptomatic and Asymptomatic Episodes Pre and Post Radiofrequency Ablation of Atrial Fibrillation |
| Study Start Date : | September 2008 |
| Actual Primary Completion Date : | April 2014 |
| Actual Study Completion Date : | December 2014 |
| Arm | Intervention/treatment |
|---|---|
|
A
Implantable Loop Recorder (ILR) implant
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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 |
- Incidence of asymptomatic versus symptomatic AF pre-ablation [ Time Frame: 3 months ]
- Incidence of asymptomatic versus symptomatic AF recurrence > 3months post-AF ablation in patients with "success" after ablation. [ Time Frame: 30 months ]
- Incidence of asymptomatic versus symptomatic AF recurrence > 3 months post-AF ablation in patients with "failure" after ablation [ Time Frame: 30 months ]
- Incidence of peri-procedural and post-procedural embolic events [ Time Frame: 24 hours ]
- Correlation of early recurrences (<3 months post-ablation) to late recurrences (> 3 months post-ablation) [ Time Frame: 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) [ Time Frame: 30 months ]
- Comparison of "success" and "failure" rates as determined by ILR versus traditional, clinically-indicated ECG and holter monitoring [ Time Frame: 30 months ]
- Cost-effectiveness analysis of using ILR monitoring for post-AF ablation monitoring versus traditional follow-up (ECGs, holter, loop recorders) [ Time Frame: 30 months ]
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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 | |
| Canada, Ontario | |
| 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 | |
| Canada, Quebec | |
| Hôpital Général de Montréal-McGill | |
| Montréal, Quebec, Canada, H3G 1A4 | |
| Hôpital Laval | |
| 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 |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | David Birnie, M.D., Director of Arrythmia Service, Ottawa Heart Institute Research Corporation |
| ClinicalTrials.gov Identifier: | NCT00745706 History of Changes |
| Other Study ID Numbers: |
UOHI-01 |
| First Posted: | September 3, 2008 Key Record Dates |
| Last Update Posted: | March 11, 2015 |
| Last Verified: | March 2015 |
Additional relevant MeSH terms:
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Atrial Fibrillation Arrhythmias, Cardiac Heart Diseases Cardiovascular Diseases Pathologic Processes |