Discerning Symptomatic and Asymptomatic Episodes Pre and Post Radiofrequency Ablation of Atrial Fibrillation - Full Text View

Purpose

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.

Condition	Intervention
Atrial Fibrillation	Device: Implantable Loop Recorder (ILR)


Study Type:	Interventional
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

Resource links provided by NLM:

Genetics Home Reference related topics: familial atrial fibrillation

MedlinePlus related topics: Atrial Fibrillation

Genetic and Rare Diseases Information Center resources: Familial Atrial Fibrillation

U.S. FDA Resources

Further study details as provided by Ottawa Heart Institute Research Corporation:

Primary Outcome Measures:

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 ]

Secondary Outcome Measures:

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 ]


Enrollment:	50
Study Start Date:	September 2008
Study Completion Date:	December 2014
Primary Completion Date:	April 2014 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A 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

Arms

Assigned Interventions

A

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

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.

Eligibility


Ages Eligible for Study:	18 Years and older (Adult, Senior)
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00745706

Locations


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

Sponsors and Collaborators

Ottawa Heart Institute Research Corporation

Medtronic

Investigators


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

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.


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
Study First Received:	September 2, 2008
Last Updated:	March 10, 2015
Health Authority:	Canada: Ethics Review Committee Canada: Health Canada

Additional relevant MeSH terms:


Atrial Fibrillation Arrhythmias, Cardiac Heart Diseases Cardiovascular Diseases Pathologic Processes

ClinicalTrials.gov processed this record on September 23, 2016

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