Atrial FibrillationPhase 3NCT00111488
Guidant Microwave Ablation System for the Treatment of Atrial Fibrillation
A Phase 3 study testing Flex 4 and Generator in people with Atrial Fibrillation, run by Boston Scientific Corporation at 21 sites in United States.
Trial summary
The purpose of the Randomized Study of Surgical Ablation with Microwave Energy for the Treatment of Atrial Fibrillation (RESOLVE-AF) trial is to determine the safety and effectiveness of the Guidant FLEX® Microwave Surgical Ablation System in the treatment of permanent atrial fibrillation (AF). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- Flex 4 and Generator
- Type of treatment
- Medical device
- How many people
- 200 participants
- Where
- 21 sitesUnited States
- Study dates
- Jun 2005to Dec 2006
- Phase
- Phase 3
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient age >= 18 years
- Documented permanent AF (for at least three months)
- Scheduled for an open chest cardiac surgery for the primary indication of mitral valve repair or replacement
- Has been informed of the nature of the study, agrees to its provisions, and provided written informed consent, which was approved by the appropriate Institutional Review Board/Ethics Committee of the respective clinical site
Who cannot join
- Cerebral vascular accident (CVA, stroke) or transient ischemic attack (TIA) within the previous 6 months
- Myocardial infarction within the previous 6 weeks
- Documented history of pulmonary vein stenosis
- Previous ablation attempt for AF
- Previous thoracic procedures
- Left atrial size > 7.0 cm
Show all 15Show fewer
- Left ventricular ejection fraction < 30%
- Presence of left atrial or left atrial appendage thrombi
- Esophageal fistula or other stricture, untreated esophagitis, varices, dysphagia or odynophagia contraindicating transesophageal echocardiography
- Known allergy or contraindication to warfarin therapy
- Known allergy or contraindication to antiarrhythmic (Classes IA, IC, III) therapy
- Other comorbidity with reduced life expectancy of less than 1 year or protocol noncompliance that would limit follow-up
- Geographically remote or unable to return for follow-up examinations
- Pregnant or planning to become pregnant during the study
- Enrolled in any concurrent study, without Guidant written approval, that may confound the results of the study
Trial locations and contacts
21 sites in 1 country.
21 sites in 1 country
United States21 sites
Piedmont Hospital
Atlanta, Georgia, 30309
University of VIrginia Health System
Charlottesville, Virginia, 22908
Cardiopulmonary Research Science and Technology Institute
Dallas, Texas, 75230
Baylor University
Dallas, Texas, 75246
Plaza Medical Center
Fort Worth, Texas, 76104
Methodist Hospital
Indianapolis, Indiana, 46202
St. Francis Hospital and Health Center
Indianapolis, Indiana, 46237
Scripps Memorial/ Kaiser Permanente
La Jolla, California, 92037
Long Beach Memorial Medical Center
Long Beach, California, 90806
Kaiser Permanente Los Angeles Medical Center
Los Angeles, California, 90027
Wisconsin Heart Hospital
Milwaukee, Wisconsin, 53210
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
Lenox Hill Hospital
New York, New York, 10021
St. Michael's Medical Center
Newark, New Jersey, 07102
Alegent Health
Omaha, Nebraska, 48910
Providence St. Vincent Medical Center
Portland, Oregon, 97225
Valley Hospital
Ridgewood, New Jersey, 07450
Univesity of Rochester Medical
Rochester, New York, 14642
Mercy General Hospital
Sacramento, California, 95819
Virginia Masonic Clinic
Seattle, Washington, 98111
Wausau Heart and Lung Surgeons
Wausau, Wisconsin, 54401
About this study
Official title: Randomized Study of Surgical Ablation With Microwave Energy for the Treatment of Atrial Fibrillation
The purpose of the Randomized Study of Surgical Ablation with Microwave Energy for the Treatment of Atrial Fibrillation (RESOLVE-AF) trial is to determine the safety and effectiveness of the Guidant FLEX® Microwave Surgical Ablation System in the treatment of permanent atrial fibrillation (AF).
- Conditions
- Atrial Fibrillation
- Being tested
- Flex 4 and Generator
- Keywords
- atrial fibrillation
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Flex 4 and GeneratorDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
Freedom from atrial fibrillation at six months
Composite major adverse event at one month
Measured: One month
Secondary outcomes (4)
Composite Majour Adverse Events at three and 6 months
Measured: 3 months and 6 months
Restoration of normal sinus rhythm at discharge
Measured: Hospital discharge
Change in cardiac function at six month
Measured: 6 month
Change in Quality of Life at six months
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2005 (estimated)
- Study startJun 2005
- Primary completionDec 2006
- Study completionDec 2006
Why it stopped: Slow enrollment
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 Boston Scientific CorporationThe 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
- Single group
- Masking
- Single blind
- Enrolment
- 200 participants
Sponsor and investigators
- Lead sponsor
- Boston Scientific Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Michael Mack, MD, Principal investigator, Cardiopulmonary Research Science and Technology Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00111488
- Sponsor's protocol ID
- VR2045885
- Status last verified
- May 2014
- First submitted
- 20 May 2005
- Last updated
- 6 Jan 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Study of Surgical Ablation With Microwave Energy for the Treatment of Atrial Fibrillation
- ClinicalTrials.gov ID
- NCT00111488
- Acronym / sponsor ID
- VR2045885
- Conditions
- Atrial Fibrillation
- Keywords
- atrial fibrillation
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Slow enrollment
- Enrolment
- 200 participants
- Lead sponsor
- Boston Scientific CorporationIndustry (pharma, biotech, devices)
- Study start
- Jun 2005
- Primary completion
- Dec 2006 (actual)
- Study completion
- Dec 2006 (actual)
- First posted
- 23 May 2005 (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 the Randomized Study of Surgical Ablation with Microwave Energy for the Treatment of Atrial Fibrillation (RESOLVE-AF) trial is to determine the safety and effectiveness of the Guidant FLEX® Microwave Surgical Ablation System in the treatment of permanent atrial fibrillation (AF).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patient age >= 18 years
- Documented permanent AF (for at least three months)
- Scheduled for an open chest cardiac surgery for the primary indication of mitral valve repair or replacement
- Has been informed of the nature of the study, agrees to its provisions, and provided written informed consent, which was approved by the appropriate Institutional Review Board/Ethics Committee of the respective clinical site
Key exclusion criteria (15 listed)
- Cerebral vascular accident (CVA, stroke) or transient ischemic attack (TIA) within the previous 6 months
- Myocardial infarction within the previous 6 weeks
- Documented history of pulmonary vein stenosis
- Previous ablation attempt for AF
- Previous thoracic procedures
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 |
|---|---|---|
| Flex 4 and Generator | Device | – |
Primary outcome
Freedom from atrial fibrillation at six months
Composite major adverse event at one month
Time frame: One month
4 secondary outcomes
Composite Majour Adverse Events at three and 6 months
Time frame: 3 months and 6 months
Restoration of normal sinus rhythm at discharge
Time frame: Hospital discharge
Change in cardiac function at six month
Time frame: 6 month
Change in Quality of Life at six months
Time frame: 6 months
Results and safety
The study was stopped early (reason given: Slow enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2016.
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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
Active, not recruitingObservational study
Concomitant Left Atrial Appendage Closure and Pulsed Field Ablation-Asia
Concomitant Procedures, Atrial Fibrillation
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CONVERGE Post-Approval Study (PAS)
Chronic Atrial Fibrillation
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Early Closure of Left Atrial Appendage for Patients With Atrial Fibrillation and Ischemic Stroke Despite Anticoagulation Therapy
Ischemic Stroke, Atrial Fibrillation
RecruitingPhase 2
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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.
Michael Mack, MD principal investigator
Cardiopulmonary Research Science and Technology Institute
21 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 Flex 4 and Generator in people with Atrial Fibrillation, run by Boston Scientific Corporation at 21 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 4 inclusion and 15 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 6 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 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?
The study was stopped early (reason given: Slow enrollment). Results are not available in the source record.
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 at six months. The study lists 2 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 6 Jan 2016.