Paroxysmal Atrial FibrillationPhase 3MAGELLANNCT00741611
Study of HD Mesh Ablation System for Treatment of Paroxysmal Atrial Fibrillation
A Phase 3 study testing HD Mesh Ablation System and Anti-arrhythmic drugs in people with Paroxysmal Atrial Fibrillation, run by C. R. Bard at 13 sites in United States.
Trial summary
This is a randomized controlled study of the Bard High Density Mesh Ablation System for treatment of paroxysmal atrial fibrillation. This study will determine if the HD Mesh Ablation System is as safe as and more effective than anti-arrhythmic drugs. Read more about this study
- Who is it for?
- Ages 21 to 75 years
- Conditions the study is for
- Paroxysmal Atrial Fibrillation
- What is being tested?
- HD Mesh Ablation System and Anti-arrhythmic drugs
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 13 sitesUnited States
- Study dates
- Jul 2008to Nov 2009
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 21 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with symptomatic paroxysmal atrial fibrillation who have failed at least one class I or III anti-arrhythmic drug
- Other inclusion criteria
Who cannot join
- Previous surgical or catheter ablation to treat AF
- Permanent AF
- Uncontrolled or unstable medical conditions
- Other exclusion criteria
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
United States13 sites
Lehigh Valley Heart Specialists
Allentown, Pennsylvania, 18103
Piedmont Hospital Research Institute
Atlanta, Georgia, 30309
Aurora Denver Cardiology Associates
Aurora, Colorado, 80012
Northeast Cardiology Associates
Bangor, Maine, 04401
Massachusetts General Hospital
Boston, Massachusetts, 02114
Caritas St. Elizabeth's Medical Center
Boston, Massachusetts, 02135
University of Florida
Gainesville, Florida, 32610
Mayo Clinic
Jacksonville, Florida, 32224
Florida Heart Group
Orlando, Florida, 32803
Rhode Island Hospital
Providence, Rhode Island, 02903
University of California, San Diego Medical Center
San Diego, California, 92103
St. John's Medical Research Institute
Springfield, Missouri, 65807
Bay Heart Group
Tampa, Florida, 33607
About this study
Official title: A Randomized Controlled Trial of Radiofrequency Ablation for the Treatment of Paroxysmal Atrial Fibrillation Using the Bard High Density Mesh Ablation System (MAGELLAN)
This is a randomized controlled study of the Bard High Density Mesh Ablation System for treatment of paroxysmal atrial fibrillation. This study will determine if the HD Mesh Ablation System is as safe as and more effective than anti-arrhythmic drugs.
- Conditions
- Paroxysmal Atrial Fibrillation
- Being tested
- HD Mesh Ablation System, Anti-arrhythmic drugs
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HD Mesh Ablation SystemDevice
Ablation using the HD Mesh Ablation System
Anti-arrhythmic drugsDrug
5 anti-arrhythmic drugs administered at the labeled dosage for atrial fibrillation
| Study group | Role | What they receive |
|---|---|---|
| Mesh | Experimental | Ablation with HD Mesh Ablation System Receives: Device: HD Mesh Ablation System |
| Drug | Active comparator | Treatment with anti-arrhythmic drugs Receives: Drug: Anti-arrhythmic drugs |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Major Complications
A Major Complication was defined as any adverse event that met the following criteria: 1) event was a Serious Adverse Event; 2) event was related to study device (mesh/mesh toolkit) or study procedure and 3)event was a) a cardiovascular adverse event occurring within 7 days of the procedure and/or b) a direct ablation effect adverse event occurring within 12 months of the study procedure.
Measured: 12 months
Number of Participants With Serious Atrial Fibrillation Events
Due to the early study termination and the small number of randomized patients (seven), this primary endpoint analysis (comparison of the rate of events in the mesh group to the rate in the drug group) could not be performed. Counts of events occurring in the 36 treated patients are reported by study group instead.
Measured: 12 months
Number of Participants With Freedom From Symptomatic Atrial Fibrillation
Due to the early termination and the enrollment of only seven randomized patients, the endpoint was not evaluable.
Measured: 12 months
Secondary outcomes (2)
Number of Participants With the Occurrence of Pulmonary Vein Stenosis in Mesh Treated Patients.
Defined as a greater than or equal to 70% diameter reduction in a pulmonary vein compared with the baseline measurement as assessed by an independent core imaging laboratory.
Measured: 12 months
Number of Participants With Acute Procedural Success in Mesh Treated Patients.
Acute procedural success was defined as the ability to isolate 3 of 4 pulmonary veins with the mesh ablation system alone without the need for further ablation with a distal tip catheter
Measured: During the mesh ablation procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2008 (estimated)
- Study startJul 2008
- Primary completionNov 2009
- Study completionNov 2009
Why it stopped: Business reasons
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Paroxysmal Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by C. R. BardThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- C. R. Bard
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Anne Marie Harcarik, Study director, C. R. Bard, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00741611
- Sponsor's protocol ID
- BEP-4408-2007
- Other IDs
- IDE # G070179
- Acronym
- MAGELLAN
- Status last verified
- Sep 2012
- First submitted
- 25 Aug 2008
- Last updated
- 26 Oct 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of Radiofrequency Ablation for the Treatment of Paroxysmal Atrial Fibrillation Using the Bard High Density Mesh Ablation System (MAGELLAN)
- ClinicalTrials.gov ID
- NCT00741611
- Acronym / sponsor ID
- MAGELLAN / BEP-4408-2007
- Conditions
- Paroxysmal Atrial Fibrillation
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Business reasons
- Enrolment
- 44 participants (actual)
- Lead sponsor
- C. R. BardIndustry (pharma, biotech, devices)
- Study start
- Jul 2008
- Primary completion
- Nov 2009 (actual)
- Study completion
- Nov 2009 (actual)
- First posted
- 26 Aug 2008 (estimated)
- Results
- Posted 26 Oct 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a randomized controlled study of the Bard High Density Mesh Ablation System for treatment of paroxysmal atrial fibrillation. This study will determine if the HD Mesh Ablation System is as safe as and more effective than anti-arrhythmic drugs.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mesh | Experimental | Device: HD Mesh Ablation SystemAblation with HD Mesh Ablation System |
| Drug | Active comparator | Drug: Anti-arrhythmic drugsTreatment with anti-arrhythmic drugs |
Who may qualify
- Ages
- 21 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with symptomatic paroxysmal atrial fibrillation who have failed at least one class I or III anti-arrhythmic drug
- Other inclusion criteria
Key exclusion criteria (4 listed)
- Previous surgical or catheter ablation to treat AF
- Permanent AF
- Uncontrolled or unstable medical conditions
- Other exclusion criteria
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 |
|---|---|---|
| HD Mesh Ablation SystemAblation using the HD Mesh Ablation System | Device | Mesh |
| Anti-arrhythmic drugs5 anti-arrhythmic drugs administered at the labeled dosage for atrial fibrillation | Drug | Drug |
Primary outcome
Number of Participants With Major Complications
Time frame: 12 months
A Major Complication was defined as any adverse event that met the following criteria: 1) event was a Serious Adverse Event; 2) event was related to study device (mesh/mesh toolkit) or study procedure and 3)event was a) a cardiovascular adverse event occurring within 7 days of the procedure and/or b) a direct ablation effect adverse event occurring within 12 months of the study procedure.
Number of Participants With Serious Atrial Fibrillation Events
Time frame: 12 months
Due to the early study termination and the small number of randomized patients (seven), this primary endpoint analysis (comparison of the rate of events in the mesh group to the rate in the drug group) could not be performed. Counts of events occurring in the 36 treated patients are reported by study group instead.
Number of Participants With Freedom From Symptomatic Atrial Fibrillation
Time frame: 12 months
Due to the early termination and the enrollment of only seven randomized patients, the endpoint was not evaluable.
2 secondary outcomes
Number of Participants With the Occurrence of Pulmonary Vein Stenosis in Mesh Treated Patients.
Time frame: 12 months
Number of Participants With Acute Procedural Success in Mesh Treated Patients.
Time frame: During the mesh ablation procedure
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Paroxysmal Atrial Fibrillation
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Horizon 360 Protocol for the Treatment of Paroxysmal Atrial Fibrillation With the Sphere-360™ Catheter and Affera™ Mapping and Ablation System (Horizon 360)
Paroxysmal AF
RecruitingObservational study
A Study of Varipulse Catheter in Participants With Paroxysmal Atrial Fibrillation Under Optimized Sedation
Atrial Fibrillation
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A Study Assessing Arrhythmia Mapping With a Multi-Electrode Mapping Catheter
Scar-related Atrial Tachycardia, Persistent Atrial Fibrillation
Active, not recruiting
A Study of VARIPULSE Catheter and TRUPULSE Generator With VARIPULSE Pro Software in Participants With PAF or PsAF
Atrial Fibrillation
Not yet recruitingObservational study
Catheter Ablation Using a Novel Navigation and Imaging System
Paroxysmal Atrial Fibrillation
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.
Anne Marie Harcarik study director
C. R. Bard, Inc.
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing HD Mesh Ablation System and Anti-arrhythmic drugs in people with Paroxysmal Atrial Fibrillation, run by C. R. Bard at 13 sites in United States.
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 2 inclusion and 4 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: stopped early, as of the sponsor's last update on 26 Oct 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in United States. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Oct 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants With Major Complications (time frame: 12 months). The study lists 3 primary outcomes in all. 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 26 Oct 2012.