Atrial FibrillationPhase 2RESTORE SR IINCT00566176
Sole-Therapy Treatment of Atrial Fibrillation
A Phase 2 study testing Surgical Ablation using the AtriCure Bipolar System in people with Atrial Fibrillation, run by AtriCure, Inc. at 5 sites in United States.
Trial summary
RESTORE SR II is a feasibility study on the minimally invasive use of the AtriCure Bipolar System for PV Isolation on a beating heart for the treatment of all types of atrial fibrillation in a sole therapy operation (not concomitant to another cardiac operation). 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?
- Surgical Ablation using the AtriCure Bipolar System
- Type of treatment
- Medical device
- How many people
- 25 participants
- Where
- 5 sitesUnited States
- Study dates
- Oct 2005to Feb 2017
- Phase
- Phase 2
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female patient between 18 and 80 years of age
- Patient with symptomatic AF and failure or intolerance of one or more Class I or Class III AADs and:
- Who describes 3 or more symptomatic AF episodes during the 6 month period prior to enrollment, with at least 1 electrocardiographically documented episode of AF in the 4 months prior to enrollment or,
- Who has documented AF within the 6 months proceeding enrollment that did not terminate spontaneously (including patients in continuous AF) or,
- Who is unwilling or unable to take anticoagulants, with 3 or more symptomatic episodes during the 6 month period prior to enrollment with at least 1 electrocardiographically documented episode of AF in the 4 months prior to enrollment.
- Left Atrial Size < 6 cm (determined by echocardiography performed within 60 days of enrollment), unless the LV dysfunction is thought to result (at least in part) from AF
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- Left Ventricular Ejection Fraction ≥ 30% (determined by echocardiography performed within 60 days of enrollment)
- Patient is willing and able to provide written informed consent.
- Patient has a life expectancy of at least 2 years.
- Patient is willing and able to attend the scheduled follow-up visits.
- Weight < 325 lbs
Who cannot join
- Prior cardiac catheter ablation for the treatment of arrhythmia within 4 months
- Prior cardiac surgery
- Patients requiring any open heart procedure (e.g. CABG, valve replacement or repair, atrial septal defect repair, etc.)
- Class IV NYHA heart failure symptoms, unless these symptoms are considered to be due to uncontrolled AF
- Cerebrovascular accident within previous 6 months
- Known carotid artery stenosis greater than 80%
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- Evidence of significant active infection
- Patient unable to undergo TEE
- Pregnant woman
- Requires anti-arrhythmic drug therapy for the treatment of ventricular arrhythmia
- Presence of thrombus in the left atrium
- Patient has co-morbid condition that in the opinion of the investigator poses undue risk of general anesthesia or port access cardiac surgery
- Patient is enrolled in another investigational study
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
University of Cincinnati
Cincinnati, Ohio, 45267
Medical City Hospital/Cardio Pulmonary Research Science and Technology Institute
Dallas, Texas, 75230
Sacred Heart Medical Center Endovascular Research
Eugene, Oregon, 97401
University of Oklahoma Cardiac Arrythmia Research Institute
Oklahoma City, Oklahoma, 73104
University Community Hospital/Dr. Kiran C. Patel Research Institute
Tampa, Florida, 33616
About this study
Official title: Thoracoscopically-Assisted Epicardial Bilateral Pulmonary Vein Isolations Using the AtriCure Bipolar System and Exclusion of the Left Atrial Appendage for the Treatment of Atrial Fibrillation
RESTORE SR II is a feasibility study on the minimally invasive use of the AtriCure Bipolar System for PV Isolation on a beating heart for the treatment of all types of atrial fibrillation in a sole therapy operation (not concomitant to another cardiac operation).
- Conditions
- Atrial Fibrillation
- Being tested
- Surgical Ablation using the AtriCure Bipolar System
- Keywords
- Atrial Fibrillation, AF, AFIB, racing heart, pulmonary vein isolation, pvi, mini maze, maze
- Medical subject headings
- Atrial Fibrillation, Tachycardia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surgical Ablation using the AtriCure Bipolar SystemDevice
Surgical Ablation using the AtriCure Bipolar System
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome is the feasibility of performing this operation by demonstrating the ability to consistently isolate the right and left PVs using this minimally invasive approach.
Measured: Perioperatively
The primary safety endpoint will be determined by assessing the rate of serious adverse events.
Measured: Discharge/30 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2007 (estimated)
- Study startOct 2005
- Primary completionDec 2007
- Study completionFeb 2017 (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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- AtriCure, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Warren Jackman, MD, Principal investigator, University of Oklamhoma Cardiac Arrythmia Research InstituteJames Edgerton, MD, Principal investigator, Medical City Hospital/Cardio Pulmonary Research Science and Technology Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00566176
- Sponsor's protocol ID
- CP2005-1
- Acronym
- RESTORE SR II
- Status last verified
- Feb 2013
- First submitted
- 30 Nov 2007
- Last updated
- 5 Feb 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Thoracoscopically-Assisted Epicardial Bilateral Pulmonary Vein Isolations Using the AtriCure Bipolar System and Exclusion of the Left Atrial Appendage for the Treatment of Atrial Fibrillation
- ClinicalTrials.gov ID
- NCT00566176
- Acronym / sponsor ID
- RESTORE SR II / CP2005-1
- Conditions
- Atrial Fibrillation
- Keywords
- Atrial Fibrillation, AF, AFIB, racing heart, pulmonary vein isolation, pvi, mini maze, maze
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (actual)
- Lead sponsor
- AtriCure, Inc.Industry (pharma, biotech, devices)
- Study start
- Oct 2005
- Primary completion
- Dec 2007 (actual)
- Study completion
- Feb 2017 (estimated)
- First posted
- 3 Dec 2007 (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.
RESTORE SR II is a feasibility study on the minimally invasive use of the AtriCure Bipolar System for PV Isolation on a beating heart for the treatment of all types of atrial fibrillation in a sole therapy operation (not concomitant to another cardiac operation).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Male or female patient between 18 and 80 years of age
- Patient with symptomatic AF and failure or intolerance of one or more Class I or Class III AADs and:
- Left Atrial Size < 6 cm (determined by echocardiography performed within 60 days of enrollment), unless the LV dysfunction is thought to result (at least in part) from AF
- Left Ventricular Ejection Fraction ≥ 30% (determined by echocardiography performed within 60 days of enrollment)
- Patient is willing and able to provide written informed consent.
Key exclusion criteria (13 listed)
- Prior cardiac catheter ablation for the treatment of arrhythmia within 4 months
- Prior cardiac surgery
- Patients requiring any open heart procedure (e.g. CABG, valve replacement or repair, atrial septal defect repair, etc.)
- Class IV NYHA heart failure symptoms, unless these symptoms are considered to be due to uncontrolled AF
- Cerebrovascular accident within previous 6 months
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 |
|---|---|---|
| Surgical Ablation using the AtriCure Bipolar SystemSurgical Ablation using the AtriCure Bipolar System | Device | – |
Primary outcome
The primary outcome is the feasibility of performing this operation by demonstrating the ability to consistently isolate the right and left PVs using this minimally invasive approach.
Time frame: Perioperatively
The primary safety endpoint will be determined by assessing the rate of serious adverse events.
Time frame: Discharge/30 Days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2013.
Related trials for Atrial Fibrillation
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Paroxysmal AF
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Concomitant Left Atrial Appendage Closure and Pulsed Field Ablation-Asia
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CONVERGE Post-Approval Study (PAS)
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Early Closure of Left Atrial Appendage for Patients With Atrial Fibrillation and Ischemic Stroke Despite Anticoagulation Therapy
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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
University of Oklamhoma Cardiac Arrythmia Research Institute
James Edgerton, MD principal investigator
Medical City Hospital/Cardio Pulmonary Research Science and Technology Institute
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Surgical Ablation using the AtriCure Bipolar System in people with Atrial Fibrillation, run by AtriCure, Inc. at 5 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 11 inclusion and 13 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: status not confirmed, as of the sponsor's last update on 5 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
The primary outcome is the feasibility of performing this operation by demonstrating the ability to consistently isolate the right and left PVs using this minimally invasive approach. (time frame: Perioperatively). 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 5 Feb 2013.