Atrial FibrillationCONVERT-AFNCT00519194
CONcomitant eValuation of Epicor Left atRial Therapy for AF
A study testing Epicor LP Cardiac Ablation System and Surgical ablation of permanent AF in people with Atrial Fibrillation, run by Abbott Medical Devices at 15 sites in United States.
Trial summary
The purpose of this study is to test the safety and efficacy of the Epicor LP Cardiac Ablation System for treating permanent atrial fibrillation during concomitant open chest and/or open heart surgery for one of more of the following procedures: mitral valve repair or replacement, aortic valve repair or replacement… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- Epicor LP Cardiac Ablation System and Surgical ablation of permanent AF
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 112 participants
- Where
- 15 sitesUnited States
- Study dates
- Apr 2009to Mar 2013
- Phase
- Interventional
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18-80 years old
- Permanent AF defined as continuous AF lasting > one year OR non self-terminating AF lasting > seven days but no more than one year with at least one failed DC cardioversion
- Have a concomitant indication for open chest and/or open heart surgery for one or more of the following: mitral valve repair or replacement, aortic valve repair or replacement, tricuspid valve repair or replacement, patent foramen ovale (PFO) closure or coronary artery bypass surgery
- Be able to take anticoagulation therapy
- Be able to fulfill study requirements
- Be able to sign study-specific informed consent
Who cannot join
- Presence of a previously implanted device in or adjacent to the treatment target area that may alter the delivery of therapy
- Prior cardiac surgery
- Presence of active endocarditis, local or system infection
- Presence of advanced heart failure (NYHA class > II, \& LVEF < 20%)
- Intraaortic balloon pump, IV inotropes or vasoactive agents within 30 days
- Emergent cardiac surgery due to acute MI or acute mitral regurgitation
Show all 14Show fewer
- Life expectancy < 1 year
- Major or progressive non-cardiac disease
- Presence of left atrial thrombi
- Left atrial diameter > 6.0 cm
- Any condition that prevents investigator from safely performing procedure
- Positive urine or serum pregnancy test
- Prior left atrial ablation
- Currently participating in another clinical research study
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
United States15 sites
Mission Hospital, Inc
Asheville, North Carolina, 28801
Midatlanatic Cardiovascular Associates, PA; Union Memorial Hospital
Baltimore, Maryland, 21218
Manatee Memorial Hospital
Bradenton, Florida, 34208
Blake Medical Center
Bradenton, Florida, 34209
Duke University Medical Center
Durham, North Carolina, 27710
NorthShore University Health System
Evanston, Illinois, 60201
St. Agnes Medical Center
Fresno, California, 93720
Hackensack University Medical Center
Hackensack, New Jersey, 07601
Minneapolis Heart Institute Foundation/Abbott NW Hospital
Minneapolis, Minnesota, 55407
Community Hospital
Munster, Indiana, 46321
Cardiology Consultants, MD's PA (Baptist Hospital)
Pensacola, Florida, 32501
University of Rochester Medical Center
Rochester, New York, 14642
St. Francis Hospital
Roslyn, New York, 11576
William Beaumont Hospital
Royal Oak, Michigan, 48073
HealthEast St. Joseph's Hospital
Saint Paul, Minnesota, 55102
About this study
The purpose of this study is to test the safety and efficacy of the Epicor LP Cardiac Ablation System for treating permanent atrial fibrillation during concomitant open chest and/or open heart surgery for one of more of the following procedures: mitral valve repair or replacement, aortic valve repair or replacement, tricuspid valve repair or replacement, coronary artery bypass surgery or patent foramen ovale (PFO closure).
- Conditions
- Atrial Fibrillation
- Being tested
- Epicor LP Cardiac Ablation System, Surgical ablation of permanent AF
- Keywords
- Arrhythmia, Atrial Fibrillation
- 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.
Epicor LP Cardiac Ablation SystemDevice
Surgical ablation of permanent AF during concomitant open chest and/or open heart surgery
Surgical ablation of permanent AFProcedure or surgery
Concomitant AF ablation during mitral valve surgery
| Study group | Role | What they receive |
|---|---|---|
| Epicor Cardiac Ablation | Experimental | Not described Receives: Device: Epicor LP Cardiac Ablation System; Procedure: Surgical ablation of permanent AF |
What is being measured
The primary outcome is the main question the study is designed to answer.
Freedom From Atrial Fibrillation in the Absence of Any AF Therapies
Freedom from atrial fibrillation (AF) at 6 months in absence of any AF therapies.
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 posted22 Aug 2007 (estimated)
- Study startApr 2009
- Primary completionMar 2013
- Study completionMar 2013
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 Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by Abbott Medical DevicesThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 112 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Medical Devices
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mark Groh, MD, Principal investigator, Mission Hospitals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00519194
- Sponsor's protocol ID
- 051.13
- Acronym
- CONVERT-AF
- Status last verified
- Feb 2019
- First submitted
- 20 Aug 2007
- Last updated
- 19 Feb 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CONcomitant eValuation of Epicor Left atRial Therapy for AF
- ClinicalTrials.gov ID
- NCT00519194
- Acronym / sponsor ID
- CONVERT-AF / 051.13
- Conditions
- Atrial Fibrillation
- Keywords
- Arrhythmia, Atrial Fibrillation
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 112 participants (actual)
- Lead sponsor
- Abbott Medical DevicesIndustry (pharma, biotech, devices)
- Study start
- Apr 2009
- Primary completion
- Mar 2013 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 22 Aug 2007 (estimated)
- Results
- Posted 5 May 2014
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 test the safety and efficacy of the Epicor LP Cardiac Ablation System for treating permanent atrial fibrillation during concomitant open chest and/or open heart surgery for one of more of the following procedures: mitral valve repair or replacement, aortic valve repair or replacement, tricuspid valve repair or replacement, coronary artery bypass surgery or patent foramen ovale (PFO closure).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Epicor Cardiac Ablation | Experimental | Device: Epicor LP Cardiac Ablation System, Procedure: Surgical ablation of permanent AF |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 18-80 years old
- Permanent AF defined as continuous AF lasting > one year OR non self-terminating AF lasting > seven days but no more than one year with at least one failed DC cardioversion
- Have a concomitant indication for open chest and/or open heart surgery for one or more of the following: mitral valve repair or replacement, aortic valve repair or replacement, tricuspid valve repair or replacement, patent foramen ovale (PFO) closure or coronary artery bypass surgery
- Be able to take anticoagulation therapy
- Be able to fulfill study requirements
Key exclusion criteria (14 listed)
- Presence of a previously implanted device in or adjacent to the treatment target area that may alter the delivery of therapy
- Prior cardiac surgery
- Presence of active endocarditis, local or system infection
- Presence of advanced heart failure (NYHA class > II, \& LVEF < 20%)
- Intraaortic balloon pump, IV inotropes or vasoactive agents within 30 days
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 |
|---|---|---|
| Epicor LP Cardiac Ablation SystemSurgical ablation of permanent AF during concomitant open chest and/or open heart surgery | Device | Epicor Cardiac Ablation |
| Surgical ablation of permanent AFConcomitant AF ablation during mitral valve surgery | Procedure or surgery | Epicor Cardiac Ablation |
Primary outcome
Freedom From Atrial Fibrillation in the Absence of Any AF Therapies
Time frame: 6 months
Freedom from atrial fibrillation (AF) at 6 months in absence of any AF therapies.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Atrial Fibrillation
Active, not recruiting
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
Active, not recruiting
CONVERGE Post-Approval Study (PAS)
Chronic Atrial Fibrillation
Recruiting
Early Closure of Left Atrial Appendage for Patients With Atrial Fibrillation and Ischemic Stroke Despite Anticoagulation Therapy
Ischemic Stroke, Atrial Fibrillation
RecruitingPhase 2
Safety in Adult Participants With Atrial Fibrillation Who Are Treated With Anticoagulation
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.
Mark Groh, MD principal investigator
Mission Hospitals
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Epicor LP Cardiac Ablation System and Surgical ablation of permanent AF in people with Atrial Fibrillation, run by Abbott Medical Devices at 15 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 6 inclusion and 14 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 19 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 May 2014). 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?
Freedom From Atrial Fibrillation in the Absence of Any AF Therapies (time frame: 6 months). 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 19 Feb 2019.