Atrial FibrillationPhase 3ANCT00785902
AtriCure Bipolar Radiofrequency Ablation of Persistent Atrial Fibrillation
A Phase 3 study testing AtriCure Bipolar System in people with Atrial Fibrillation, run by AtriCure, Inc..
Trial summary
ABLATE Persistent is a prospective, non-randomized multi-center clinical trial to demonstrate the safety and effectiveness of the AtriCure Bipolar System for treating persistent atrial fibrillation during concomitant on-pump cardiac surgery. 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?
- AtriCure Bipolar System
- Type of treatment
- Medical device
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Start not givento not given
- 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
- Subject is greater than or equal to 18 years of age
- Subject has history of persistent atrial fibrillation as defined by the ACC/AHA/ESC Guidelines
- Subject is scheduled to undergo elective on-pump cardiac surgical procedure(s) for one or more of the following:
- Mitral valve repair or replacement
- Aortic valve repair or replacement
- Tricuspid valve repair or replacement
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- Coronary Artery Bypass procedures
- Subject's Left Ventricular Ejection Fraction ≥ 30%
- Subject is able and willing to provide written informed consent and comply with study requirements
- Subject has life expectancy of at least 1 year
Who cannot join
- Patients with longstanding and continuous AF in which cardioversion has failed or has not been attempted
- Previous cardiac ablation including catheter ablation, AV-nodal ablation, or surgical Maze procedure
- Wolff-Parkinson-White syndrome
- Prior cardiac surgery (Redo)
- Class IV NYHA heart failure symptoms
- Prior history of cerebrovascular accidents within 6 months or at any time if there is residual neurological deficit
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- Documented MI within 6 weeks prior to study enrollment
- Need for emergent cardiac surgery (i.e. cardiogenic shock)
- Known carotid artery stenosis greater than 80%
- LA size greater than or equal to 8 cm
- Current diagnosis of active systemic infection
- Severe peripheral arterial occlusive disease defined as claudication with minimal exertion
- Pregnancy or desire to get pregnant within 12-months of the study enrollment
- Preoperative need for an intra-aortic balloon pump or intravenous inotropes
- Renal failure requiring dialysis or hepatic failure
- Requires anti-arrhythmic drug therapy for the treatment of a ventricular arrhythmia
- Therapy resulting in compromised tissue integrity including: thoracic radiation, chemotherapy, long term treatment with oral or injected steroids, or known connective tissue disorders
About this study
ABLATE Persistent is a prospective, non-randomized multi-center clinical trial to demonstrate the safety and effectiveness of the AtriCure Bipolar System for treating persistent atrial fibrillation during concomitant on-pump cardiac surgery.
- Conditions
- Atrial Fibrillation
- Being tested
- AtriCure Bipolar System
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AtriCure Bipolar SystemDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary efficacy endpoint for this study is the percent of patients free from AF and off Class I and III antiarrhythmic drugs at 9 months.
The primary safety endpoint is the composite acute major adverse event rate, within 30 days post-procedure or hospital discharge
Secondary outcomes (2)
The secondary efficacy endpoint for this study is the percent of patients free from AF, independent of antiarrhythmic drug status at 9 months
The secondary safety endpoint is the composite 9-month post-procedure major adverse event rate.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2008 (estimated)
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
Sponsor and investigators
- Lead sponsor
- AtriCure, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00785902
- Sponsor's protocol ID
- CP2008-1
- Acronym
- A
- Status last verified
- Feb 2011
- First submitted
- 3 Nov 2008
- Last updated
- 21 Feb 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- AtriCure Bipolar Radiofrequency Ablation of Persistent Atrial Fibrillation
- ClinicalTrials.gov ID
- NCT00785902
- Acronym / sponsor ID
- A / CP2008-1
- Conditions
- Atrial Fibrillation
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Lead sponsor
- AtriCure, Inc.Industry (pharma, biotech, devices)
- First posted
- 5 Nov 2008 (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.
ABLATE Persistent is a prospective, non-randomized multi-center clinical trial to demonstrate the safety and effectiveness of the AtriCure Bipolar System for treating persistent atrial fibrillation during concomitant on-pump cardiac surgery.
Study design
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Subject is greater than or equal to 18 years of age
- Subject has history of persistent atrial fibrillation as defined by the ACC/AHA/ESC Guidelines
- Subject is scheduled to undergo elective on-pump cardiac surgical procedure(s) for one or more of the following:
- Subject's Left Ventricular Ejection Fraction ≥ 30%
- Subject is able and willing to provide written informed consent and comply with study requirements
Key exclusion criteria (17 listed)
- Patients with longstanding and continuous AF in which cardioversion has failed or has not been attempted
- Previous cardiac ablation including catheter ablation, AV-nodal ablation, or surgical Maze procedure
- Wolff-Parkinson-White syndrome
- Prior cardiac surgery (Redo)
- Class IV NYHA heart failure symptoms
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 |
|---|---|---|
| AtriCure Bipolar System | Device | – |
Primary outcome
The primary efficacy endpoint for this study is the percent of patients free from AF and off Class I and III antiarrhythmic drugs at 9 months.
The primary safety endpoint is the composite acute major adverse event rate, within 30 days post-procedure or hospital discharge
2 secondary outcomes
The secondary efficacy endpoint for this study is the percent of patients free from AF, independent of antiarrhythmic drug status at 9 months
The secondary safety endpoint is the composite 9-month post-procedure major adverse event rate.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2011.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing AtriCure Bipolar System in people with Atrial Fibrillation, run by AtriCure, Inc..
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 10 inclusion and 17 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: withdrawn, as of the sponsor's last update on 21 Feb 2011. Status can change between updates, so confirm with the study contact before making plans.
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 withdrawn before enrolling participants, so there are no results.
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?
The primary efficacy endpoint for this study is the percent of patients free from AF and off Class I and III antiarrhythmic drugs at 9 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 21 Feb 2011.