Atrial FibrillationPhase 3NCT00392106
High Intensity Focused Ultrasound (HIFU) Ablation System Study
A Phase 3 study testing propafenone, flecainide and dofetilide in people with Atrial Fibrillation, run by ProRhythm, Inc. at 21 sites in 2 countries.
Trial summary
The purpose of this study is to determine if the HIFU Pulmonary Vein Ablation System is effective in the treatment of paroxysmal Atrial Fibrillation compared to the control of best medical therapy with FDA approved antiarrhythmic drugs. 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?
- propafenone, flecainide and dofetilide
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 21 sitesin 2 countries
- Study dates
- Apr 2006to Jun 2011
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Documented atrial fibrillation
- Failed or intolerant to at least 1 anti-arrhythmic drug
- Able to take anti-coagulant therapy
- Able to complete screening tests required for inclusion/exclusion criteria
- Able to take at least 1 approved anti-arrhythmic drug
- Not pregnant
- Available for follow-up for at least 12 months
Who cannot join
- Persistent or permanent atrial fibrillation
- Mitral disease
- Prior surgical treatment for atrial fibrillation
- Ablation for treatment of atrial fibrillation within 6 months
- Severe left ventricular hypertrophy
- Known untreated coagulopathy
Show all 16Show fewer
- Unstable angina
- Prior stroke
- Uncontrolled heart failure
- Secondary causes of atrial fibrillation
- Uncorrected hyperthyroidism within 12 months
- Pulmonary embolism within 6 months
- Pneumonia or acute pulmonary disease within 3 months
- Pacemaker/ICD
- High risk for esophageal disease
- Currently enrolled in investigational drug or device study
Trial locations and contacts
21 sites in 2 countries.
21 sites in 2 countries
United States20 sites
Piedmont Hospital
Atlanta, Georgia, 30309
Texas Cardiac Arrhythmia Research
Austin, Texas, 78705
Johns Hopkins Hopsital
Baltimore, Maryland, 21287
Lahey Clinic
Burlington, Massachusetts, 01805
Medical University of South Carolina
Charleston, South Carolina, 29425
University of Virginia
Charlottesville, Virginia, 22903
Hillcrest Hospital
Cleveland, Ohio, 44124
Cleveland Clinic Foundation
Cleveland, Ohio, 44195
The Ohio State University Heart Center
Columbus, Ohio, 43210
University of Texas, Southwestern
Dallas, Texas, 75390
Fullerton Vascular Medical Group
Fullerton, California, 92835
Lexington Central Baptist Hospital
Lexington, Kentucky, 40503
University of California, Los Angeles
Los Angeles, California, 90095
New York University Hospital
New York, New York, 10016
Sentara Norfolk General Hospital
Norfolk, Virginia, 23507
Oklahoma University Health Sciences Center
Oklahoma City, Oklahoma, 73104
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Beaumont Hospital
Royal Oak, Michigan, 48220
Stony Brook University Hospital
Stony Brook, New York, 11794
Wake Forest University Health Systems
Winston-Salem, North Carolina, 27157
About this study
Official title: Study of Focused Circumferential UltraSound for the Treatment of Atrial Fibrillation
The purpose of this study is to determine if the HIFU Pulmonary Vein Ablation System is effective in the treatment of paroxysmal Atrial Fibrillation compared to the control of best medical therapy with FDA approved antiarrhythmic drugs.
Read the detailed description
Atrial fibrillation (AF) is the most common sustained cardiac arrhythmia affecting an estimated 2.2 million persons in the United States (US). In addition to being debilitating, AF has been identified as a leading risk factor for stroke. AF is often associated with structural heart disease, but a substantial number of AF patients have little or no detectable structural heart disease. A patient with AF is up to 5 times more likely to have a stroke than the general population.
Recently, it has been demonstrated that for a significant portion of AF patients (80% - 95 %) the arrhythmia originates in one of the four pulmonary veins (PV's). Furthermore, it has been shown that isolation of this arrhythmia by ablation can, in the majority of patients (50-70%), eliminate or markedly reduce episodes of AF. Currently, there are a number of modalities being investigated to treat AF. They include radiofrequency, laser, thermal, cryo, microwave, and ultrasound ablation of targeted areas in the atrium and/or PVs.
Comparison(s): Clinical success of High Intensity Focused Ultrasound (HIFU) Ablation for Pulmonary Vein Isolation in the treatment of Atrial Fibrillation, compared to medical therapy with anti-arrhythmic drugs (AADs).
- Conditions
- Atrial Fibrillation
- Being tested
- propafenone, flecainide, dofetilide, sotolol, Pulmonary vein ablation
- Keywords
- atrial fibrillation, arrhythmia, AF ablation, antiarrhythmic agent, catheter ablation, pulmonary veins
- Medical subject headings
- Atrial Fibrillation, Arrhythmias, Cardiac
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
propafenoneDrug
Also called Rhyhmol
Anti-arrhythmic drug prescribed for treatment of atrial fibrillation
flecainideDrug
Also called Tambocor
Anti-arrhythmic drug prescribed for the treatment of Atrial fibrillation
dofetilideDrug
Also called Tikosyn
Anti-arrhythmic drug prescribed for treatment of atrial fibrillation
sotololDrug
Also called Betapace
Anti-arrhythmic Drug prescribed for treatment of Atrial Fibrillation
Pulmonary vein ablationDevice
Also called Left atrial ablation
Electrical isolation of pulmonary vein with high-intensity focused ultrasound
AmiodaroneDrug
Also called Pacerone
Anti-arrhythmic Drug prescribed for the treatment of Atrial Fibrillation
| Study group | Role | What they receive |
|---|---|---|
| Control | Active comparator | Class I or III anti-arrhythmic drug for the treatment of AF Receives: Drug: propafenone; Drug: flecainide; Drug: dofetilide; Drug: sotolol; Drug: Amiodarone |
| Treatment | Experimental | Pulmonary vein ablation with HIFU Receives: Device: Pulmonary vein ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acute treatment with elimination of AF episodes
Measured: 12 months
Death, stroke, and hospitalization for recurrence of AF
Measured: within 12 months of treatment
Secondary outcomes (1)
Acute treatment success
Measured: 60 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2006 (estimated)
- Study startApr 2006
- Primary completionDec 2010 (estimated)
- Study completionJun 2011 (estimated)
Why it stopped: voluntarily by Sponsor to investigate an anticipated SAE
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.
- 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
- None (open label)
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ProRhythm, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Warren Jackman, MD, Principal investigator, Oklahoma University Health Sciences CenterHugh Calkins, MD, Principal investigator, Johns Hopkins Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00392106
- Sponsor's protocol ID
- CLIN-003
- Other IDs
- NCT00392106
- Status last verified
- Jun 2008
- First submitted
- 24 Oct 2006
- Last updated
- 17 Jun 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Focused Circumferential UltraSound for the Treatment of Atrial Fibrillation
- ClinicalTrials.gov ID
- NCT00392106
- Acronym / sponsor ID
- CLIN-003
- Conditions
- Atrial Fibrillation
- Keywords
- atrial fibrillation, arrhythmia, AF ablation, antiarrhythmic agent, catheter ablation, pulmonary veins
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: voluntarily by Sponsor to investigate an anticipated SAE
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- ProRhythm, Inc.Industry (pharma, biotech, devices)
- Study start
- Apr 2006
- Primary completion
- Dec 2010 (estimated)
- Study completion
- Jun 2011 (estimated)
- First posted
- 25 Oct 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 if the HIFU Pulmonary Vein Ablation System is effective in the treatment of paroxysmal Atrial Fibrillation compared to the control of best medical therapy with FDA approved antiarrhythmic drugs.
Detailed description
Atrial fibrillation (AF) is the most common sustained cardiac arrhythmia affecting an estimated 2.2 million persons in the United States (US). In addition to being debilitating, AF has been identified as a leading risk factor for stroke. AF is often associated with structural heart disease, but a substantial number of AF patients have little or no detectable structural heart disease. A patient with AF is up to 5 times more likely to have a stroke than the general population.
Recently, it has been demonstrated that for a significant portion of AF patients (80% - 95 %) the arrhythmia originates in one of the four pulmonary veins (PV's). Furthermore, it has been shown that isolation of this arrhythmia by ablation can, in the majority of patients (50-70%), eliminate or markedly reduce episodes of AF. Currently, there are a number of modalities being investigated to treat AF. They include radiofrequency, laser, thermal, cryo, microwave, and ultrasound ablation of targeted areas in the atrium and/or PVs.
Comparison(s): Clinical success of High Intensity Focused Ultrasound (HIFU) Ablation for Pulmonary Vein Isolation in the treatment of Atrial Fibrillation, compared to medical therapy with anti-arrhythmic drugs (AADs).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Active comparator | Drug: propafenone, Drug: flecainide, Drug: dofetilide, Drug: sotolol, Drug: AmiodaroneClass I or III anti-arrhythmic drug for the treatment of AF |
| Treatment | Experimental | Device: Pulmonary vein ablationPulmonary vein ablation with HIFU |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Documented atrial fibrillation
- Failed or intolerant to at least 1 anti-arrhythmic drug
- Able to take anti-coagulant therapy
- Able to complete screening tests required for inclusion/exclusion criteria
- Able to take at least 1 approved anti-arrhythmic drug
Key exclusion criteria (16 listed)
- Persistent or permanent atrial fibrillation
- Mitral disease
- Prior surgical treatment for atrial fibrillation
- Ablation for treatment of atrial fibrillation within 6 months
- Severe left ventricular hypertrophy
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 |
|---|---|---|
| propafenoneAlso: RhyhmolAnti-arrhythmic drug prescribed for treatment of atrial fibrillation | Drug | Control |
| flecainideAlso: TambocorAnti-arrhythmic drug prescribed for the treatment of Atrial fibrillation | Drug | Control |
| dofetilideAlso: TikosynAnti-arrhythmic drug prescribed for treatment of atrial fibrillation | Drug | Control |
| sotololAlso: BetapaceAnti-arrhythmic Drug prescribed for treatment of Atrial Fibrillation | Drug | Control |
| Pulmonary vein ablationAlso: Left atrial ablationElectrical isolation of pulmonary vein with high-intensity focused ultrasound | Device | Treatment |
| AmiodaroneAlso: PaceroneAnti-arrhythmic Drug prescribed for the treatment of Atrial Fibrillation | Drug | Control |
Primary outcome
Acute treatment with elimination of AF episodes
Time frame: 12 months
Death, stroke, and hospitalization for recurrence of AF
Time frame: within 12 months of treatment
1 secondary outcome
Acute treatment success
Time frame: 60 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2008.
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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.
Warren Jackman, MD principal investigator
Oklahoma University Health Sciences Center
Hugh Calkins, MD principal investigator
Johns Hopkins Medical Center
21 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing propafenone, flecainide and dofetilide in people with Atrial Fibrillation, run by ProRhythm, Inc. at 21 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 7 inclusion and 16 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: paused, as of the sponsor's last update on 17 Jun 2008. 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, Czechia. 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?
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?
Acute treatment with elimination of AF episodes (time frame: 12 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 17 Jun 2008.