Atrial FibrillationNCT00272636
Radiofrequency Catheter Ablation for Chronic Atrial Fibrillation
A study testing Radiofrequency catheter ablation and Amiodarone and cardioversion in people with Atrial Fibrillation, run by University of Michigan at 2 sites in 2 countries.
Trial summary
The purpose of this study is to determine the long-term efficacy of radiofrequency catheter ablation in patients with chronic atrial fibrillation. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- Radiofrequency catheter ablation and Amiodarone and cardioversion
- Type of treatment
- Surgery or procedure
- How many people
- 140 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Nov 2002to Feb 2005
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Chronic atrial fibrillation
Who cannot join
- Left atrial diameter >55 mm
- Left ventricular ejection fraction <0.30
- Contraindication to amiodarone therapy or anticoagulation with warfarin
- Presence of a mechanical prosthetic valve
- History of a cerebrovascular accident
- Presence of left atrial thrombus on TEE
- Prior attempt at catheter or surgical ablation for atrial fibrillation
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
United States1 site
University of Michigan Health System
Ann Arbor, Michigan, 48109
About this study
Official title: Randomized Comparison of Radiofrequency Catheter Ablation vs. Antiarrhythmic Therapy With Amiodarone for Maintaining Sinus Rhythm in Patients With Chronic Atrial Fibrillation
The purpose of this study is to determine the long-term efficacy of radiofrequency catheter ablation in patients with chronic atrial fibrillation.
- Conditions
- Atrial Fibrillation
- Being tested
- Radiofrequency catheter ablation, Amiodarone and cardioversion
- Keywords
- atrial fibrillation, catheter ablation, amiodarone, cardioversion
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radiofrequency catheter ablationProcedure or surgery
Amiodarone and cardioversionDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Freedom from atrial fibrillation and atrial flutter in the absence of antiarrhythmic drug therapy at 1 year.
Secondary outcomes (4)
incidence of complications
changes in left atrial diameter
changes in left ventricular ejection fraction
changes in symptom severity
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2006 (estimated)
- Study startNov 2002
- Study completionFeb 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 140 participants
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- San Raffaele University Hospital, Italy
- Investigators
- Hakan Oral, MD, Principal investigator, University of MichiganFred Morady, MD, Study chair, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00272636
- Sponsor's protocol ID
- 2002-0480
- Status last verified
- Jan 2006
- First submitted
- 3 Jan 2006
- Last updated
- 3 Jun 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Comparison of Radiofrequency Catheter Ablation vs. Antiarrhythmic Therapy With Amiodarone for Maintaining Sinus Rhythm in Patients With Chronic Atrial Fibrillation
- ClinicalTrials.gov ID
- NCT00272636
- Acronym / sponsor ID
- 2002-0480
- Conditions
- Atrial Fibrillation
- Keywords
- atrial fibrillation, catheter ablation, amiodarone, cardioversion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- San Raffaele University Hospital, Italy
- Study start
- Nov 2002
- Study completion
- Feb 2005
- First posted
- 6 Jan 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine the long-term efficacy of radiofrequency catheter ablation in patients with chronic atrial fibrillation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Chronic atrial fibrillation
Key exclusion criteria (7 listed)
- Left atrial diameter >55 mm
- Left ventricular ejection fraction <0.30
- Contraindication to amiodarone therapy or anticoagulation with warfarin
- Presence of a mechanical prosthetic valve
- History of a cerebrovascular accident
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Radiofrequency catheter ablation | Procedure or surgery | – |
| Amiodarone and cardioversion | Drug | – |
Primary outcome
Freedom from atrial fibrillation and atrial flutter in the absence of antiarrhythmic drug therapy at 1 year.
4 secondary outcomes
incidence of complications
changes in left atrial diameter
changes in left ventricular ejection fraction
changes in symptom severity
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2015.
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CONVERGE Post-Approval Study (PAS)
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Atrial Fibrillation (AF)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hakan Oral, MD principal investigator
University of Michigan
Fred Morady, MD study chair
University of Michigan
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Radiofrequency catheter ablation and Amiodarone and cardioversion in people with Atrial Fibrillation, run by University of Michigan at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States, Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Freedom from atrial fibrillation and atrial flutter in the absence of antiarrhythmic drug therapy at 1 year.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2015.