- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00213408
Catheter Ablation as the First Line Therapy for Typical Atrial Flutter
June 17, 2013 updated by: University Hospital, Rouen
Catheter Ablation as the First Line Therapy for Symptomatic Typical Atrial Flutter: A Multicenter Randomized Study of Cost/Effectiveness
Catheter ablation of typical atrial flutter is a well established technique with a high acute success rate and very low complication and recurrence rates.
It has also been shown that ablation of recurrent symptomatic typical atrial flutter led to a clear improvement in quality of life.
We sought to evaluate the cost/effectiveness of catheter ablation as the first line therapy in patient suffering from their first symptomatic typical atrial flutter episode.
This study is a multicenter trial in which patients with a first symptomatic episode of typical atrial flutter are randomized to undergo ablation or to receive antiarrhythmic drugs after electrical cardioversion.
Clinical examination, quality of life questionnaires,12 leads ECG and 24-hour Holter monitoring are performed at 1, 3, 6 and 12 months following randomization.The primary end-point is the absence of recurrence of typical atrial flutter at - and 12 months of follow up.
The secondary end points are the cost and the cost/effectiveness ratio of these two approaches.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment
120
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Seine Maritime
-
Rouen, Seine Maritime, France, 76031
- CHU de Rouen
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- first episode of symptomatic typical atrial flutter
- > 18 years old
Exclusion Criteria:
- Prior antiarrhythmic drug treatment for atrial flutter
- History of cavotricuspid isthmus ablation
- Pregnancy
- Hyperthyroidism
- contraindication for anticoagulant therapy
- Life expectancy < 1 year
- contraindication to catheter ablation or to electrical cardioversion
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
Absence of typical atrial flutter recurrence at 6 and 12 months
|
Secondary Outcome Measures
Outcome Measure |
---|
Cost/effectiveness ratio at 12 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: frederic Anselme, MD, PhD, Service de Cardiologie, Rouen University Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2001
Study Completion (Actual)
January 1, 2007
Study Registration Dates
First Submitted
September 13, 2005
First Submitted That Met QC Criteria
September 13, 2005
First Posted (Estimate)
September 21, 2005
Study Record Updates
Last Update Posted (Estimate)
June 18, 2013
Last Update Submitted That Met QC Criteria
June 17, 2013
Last Verified
June 1, 2013
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1999/026/HP
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Atrial Flutter
-
Vivek ReddyEnrolling by invitationAtrial Fibrillation and Flutter | Atrial Flutter Typical | Atrial Fibrillation, Paroxysmal or PersistentUnited States
-
University of PennsylvaniaWithdrawnTypical Atrial Flutter | Risk Factors With Future Development of Atrial FlutterUnited States
-
Angelo BivianoCompleted
-
Kaiser PermanenteActive, not recruitingAtrial Fibrillation and FlutterUnited States
-
Charles University, Czech RepublicCompleted
-
Hospital Universitario Central de AsturiasJohnson & JohnsonUnknown
-
Hangzhou Dinova EP Technology Co., LtdNot yet recruiting
-
University of ManchesterManchester University NHS Foundation TrustWithdrawn
-
Abbott Medical DevicesCompletedTypical Atrial FlutterUnited States, Canada
-
Abbott Medical DevicesCompletedTypical Atrial FlutterUnited States, Canada
Clinical Trials on Radiofrequency catheter ablation of typical atrial flutter
-
University of LeipzigPhilips Healthcare; Heart Center Leipzig - University Hospital; Imricor Medical...TerminatedAtrial FlutterGermany
-
University of LeipzigPhilips Healthcare; Heart Center Leipzig - University Hospital; Imricor Medical...TerminatedAtrial FlutterGermany
-
University of LeipzigPhilips Healthcare; Heart Center Leipzig - University Hospital; Imricor Medical...Completed
-
University of California, San DiegoCatheter Robotics, Inc.CompletedAtrial Fibrillation | Atrial FlutterUnited States
-
Yonsei UniversityCompletedAtrial FibrillationKorea, Republic of
-
University Hospital, GenevaUnknownRadiofrequency Ablation | Typical Atrial Flutter | Irrigated CathetersSwitzerland
-
Stiftung Institut fuer HerzinfarktforschungBoston Scientific CorporationCompleted
-
University Hospital, RouenMedtronicCompletedAtrial Fibrillation | Atrial FlutterFrance
-
Aalborg University HospitalOdense University Hospital; St. Antonius HospitalTerminatedParoxysmal Atrial Fibrillation.Netherlands, Denmark
-
China National Center for Cardiovascular DiseasesRecruitingPulmonary Arterial HypertensionChina