Atrial FibrillationPhase 3SAAF-TNCT00734058
SOLAR & ATRILAZE Atrial Fibrillation Trial
A Phase 3 study testing Laser MAZE by Ablation of Cardiac Tissue in people with Atrial Fibrillation, run by EndoPhotonix, Inc..
Trial summary
The purpose of study is to conduct a pivotal evaluation of the EndoPhotonix™ SOLAR™ System and ATRILAZE™ System in order to obtain a labeling claim on the devices for the treatment of atrial fibrillation. 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?
- Laser MAZE by Ablation of Cardiac Tissue
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- Dec 2008to Jun 2012
- 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
- Age at least 18 years
- Documented long term persistent atrial fibrillation (also known as permanent AF).of at least 3 months duration. Persistent AF is defined as AF which is sustained beyond seven days, or lasting less than seven days but necessitating pharmacologic or electrical cardioversion. Long term persistent AF is defined as continuous AF of greater than three months duration.
- Concomitant indication for open heart surgery for at least one of the following:
- Mitral valve repair or replacement
- Aortic valve repair or replacement
- Tricuspid valve repair or replacement
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- Atrial septal defect (ASD) repair
- Patent foramen ovale (PFO) closure
- Coronary artery bypass procedure
- Be able to take anticoagulation therapy (Warfarin / Coumadin®)
- Be able to fulfill study requirements
- Willing and able to comply with the requirements of the protocol including follow-up requirements
- Willing and able to sign a study specific informed consent
Who cannot join
- Life expectancy < 1 year
- NYHA class = IV
- Left ventricular ejection fraction (LVEF) measurement <30%
- Left atrial diameter > 7.5 cm
- Wolff-Parkinson-White (WPW) Syndrome
- Pregnancy or desire to be pregnant within 1 year of the study treatment
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- Myocardial infarction within the previous 6 weeks
- Presence of a previously implanted device (valve, CS leads, or ICD)
- Known allergy, contraindication, or inability to comply with warfarin (Coumadin®) or heparin therapy
- Known allergy or contraindication to complying with anti-arrhythmic (Class IA, IC, III) therapy
- Previous thoracic procedure resulting in sternal opening and/or pericardial opening (e.g., CABG, valve replacement or repair)
- Current diagnosis of active endocarditis, local or systemic infection
- Renal failure requiring dialysis or hepatic failure
- Emergent cardiac surgery (cardiogenic shock)
- Preoperative need for intra-aortic balloon pump, IV inotropes or vasoactive agents
- Currently participating in another clinical research study
- Cerebral vascular accident or transient ischemic attack within previous 180 days or at any time with a documented residual neurological deficit
Trial locations and contacts
No sites are listed yet.
Cory H. White contact
About this study
Official title: Atrial Fibrillation Treatment Using Laser Ablation of Cardiac Tissue During Concomitant Cardiac Surgery
The purpose of study is to conduct a pivotal evaluation of the EndoPhotonix™ SOLAR™ System and ATRILAZE™ System in order to obtain a labeling claim on the devices for the treatment of atrial fibrillation.
The study will test the safety and effectiveness of the EndoPhotonix™ Laser Ablation Systems to photocoagulate cardiac tissue during cardiac surgery, to create electrical isolation of the pulmonary veins and create other electrical isolation lesions in order to treat atrial fibrillation. The surgical procedure will be conducted during concomitant mitral valve repair or replacement surgery or in combination with other cardiac surgery including aortic valve surgery, tricuspid valve surgery, or coronary artery bypass surgery.
Read the detailed description
The study objective is to generate Level II controlled data to support the expansion of indications for the SOLAR™ System based on 0-30 day data; as well as to support the expansion of indications for the SOLAR™ System and ATRILAZE™ System for the treatment of atrial fibrillation based on 180 days data. The data will be evaluated by comparing post-operative data to the historical control data. The subjects in the study cohort will receive laser ablation therapy using the investigational device during a concomitant surgical procedure.
- Conditions
- Atrial Fibrillation
- Being tested
- Laser MAZE by Ablation of Cardiac Tissue
- Keywords
- Ablation, AF, Atrial Fibrillation, Cardiac, Endocardial, Endocardium, EP, Electrophysiology, Epicardial, Epicardium, Heart, Interventional, Lesion, PVI, Pulmonary Vein, MAZE, Surgery, Surgical, Treatment, Patients with persistent AF with 3 months duration
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laser MAZE by Ablation of Cardiac TissueDevice
Also called Maze, Maze procedure
The protocol calls for the creation of the pulmonary vein isolation lesion through the use of the SOLAR™. The additional lesions are to be created using the ATRILAZE™. At surgeon discretion, the ganglia may be ablated and left and right atrial appendages may be removed.
| Study group | Role | What they receive |
|---|---|---|
| Persistent AF | Experimental | Treatment arm to be compared with historical control. Receives: Device: Laser MAZE by Ablation of Cardiac Tissue |
What is being measured
The primary outcome is the main question the study is designed to answer.
Freedom from atrial fibrillation by 24-hour 3-lead Holter Monitor at the 180 day evaluation. On or Off Class 1 and III anti-arrhythmic medication
Measured: 180 days
Acute SAE: Death, mediastinitis, myocardial infarction, stroke, transient ischemic attack (TIA), pulmonary embolism, peripheral arterial embolism, esophageal injury, pulmonary vein stenosis; phrenic nerve damage
Measured: 0 through 30 days or length of stay
Secondary outcomes (2)
SAE: Death, mediastinitis, myocardial infarction, stroke, transient ischemic attack (TIA), pulmonary embolism, peripheral arterial embolism, esophageal injury, pulmonary vein stenosis; phrenic nerve damage
Measured: 180 days
Determine binary freedom from AF, independent of anti-arrhythmic status as documented by 24 hour 3-Lead Holter Monitor. Reduction of AF burden with assumption of 100% initial burden. To establish improvement in Quality of Life.
Measured: 180 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2008 (estimated)
- Study startDec 2008
- Primary completionJan 2012 (estimated)
- Study completionJun 2012 (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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- EndoPhotonix, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Kirk S. Honour, Study chair, EndoPhotonix, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00734058
- Sponsor's protocol ID
- EP-AF-080808
- Acronym
- SAAF-T
- Status last verified
- Aug 2008
- First submitted
- 11 Aug 2008
- Last updated
- 13 Aug 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Atrial Fibrillation Treatment Using Laser Ablation of Cardiac Tissue During Concomitant Cardiac Surgery
- ClinicalTrials.gov ID
- NCT00734058
- Acronym / sponsor ID
- SAAF-T / EP-AF-080808
- Conditions
- Atrial Fibrillation
- Keywords
- Ablation, AF, Atrial Fibrillation, Cardiac, Endocardial, Endocardium, EP, Electrophysiology
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- EndoPhotonix, Inc.Industry (pharma, biotech, devices)
- Study start
- Dec 2008
- Primary completion
- Jan 2012 (estimated)
- Study completion
- Jun 2012 (estimated)
- First posted
- 13 Aug 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.
The purpose of study is to conduct a pivotal evaluation of the EndoPhotonix™ SOLAR™ System and ATRILAZE™ System in order to obtain a labeling claim on the devices for the treatment of atrial fibrillation.
The study will test the safety and effectiveness of the EndoPhotonix™ Laser Ablation Systems to photocoagulate cardiac tissue during cardiac surgery, to create electrical isolation of the pulmonary veins and create other electrical isolation lesions in order to treat atrial fibrillation. The surgical procedure will be conducted during concomitant mitral valve repair or replacement surgery or in combination with other cardiac surgery including aortic valve surgery, tricuspid valve surgery, or coronary artery bypass surgery.
Detailed description
The study objective is to generate Level II controlled data to support the expansion of indications for the SOLAR™ System based on 0-30 day data; as well as to support the expansion of indications for the SOLAR™ System and ATRILAZE™ System for the treatment of atrial fibrillation based on 180 days data. The data will be evaluated by comparing post-operative data to the historical control data. The subjects in the study cohort will receive laser ablation therapy using the investigational device during a concomitant surgical procedure.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Persistent AF | Experimental | Device: Laser MAZE by Ablation of Cardiac TissueTreatment arm to be compared with historical control. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Age at least 18 years
- Documented long term persistent atrial fibrillation (also known as permanent AF).of at least 3 months duration. Persistent AF is defined as AF which is sustained beyond seven days, or lasting less than seven days but necessitating pharmacologic or electrical cardioversion. Long term persistent AF is defined as continuous AF of greater than three months duration.
- Concomitant indication for open heart surgery for at least one of the following:
- Be able to take anticoagulation therapy (Warfarin / Coumadin®)
- Be able to fulfill study requirements
Key exclusion criteria (17 listed)
- Life expectancy < 1 year
- NYHA class = IV
- Left ventricular ejection fraction (LVEF) measurement <30%
- Left atrial diameter > 7.5 cm
- Wolff-Parkinson-White (WPW) Syndrome
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 |
|---|---|---|
| Laser MAZE by Ablation of Cardiac TissueAlso: Maze, Maze procedureThe protocol calls for the creation of the pulmonary vein isolation lesion through the use of the SOLAR™. The additional lesions are to be created using the ATRILAZE™. At surgeon discretion, the ganglia may be ablated and left and right atrial appendages may be removed. | Device | Persistent AF |
Primary outcome
Freedom from atrial fibrillation by 24-hour 3-lead Holter Monitor at the 180 day evaluation. On or Off Class 1 and III anti-arrhythmic medication
Time frame: 180 days
Acute SAE: Death, mediastinitis, myocardial infarction, stroke, transient ischemic attack (TIA), pulmonary embolism, peripheral arterial embolism, esophageal injury, pulmonary vein stenosis; phrenic nerve damage
Time frame: 0 through 30 days or length of stay
2 secondary outcomes
SAE: Death, mediastinitis, myocardial infarction, stroke, transient ischemic attack (TIA), pulmonary embolism, peripheral arterial embolism, esophageal injury, pulmonary vein stenosis; phrenic nerve damage
Time frame: 180 days
Determine binary freedom from AF, independent of anti-arrhythmic status as documented by 24 hour 3-Lead Holter Monitor. Reduction of AF burden with assumption of 100% initial burden. To establish improvement in Quality of Life.
Time frame: 180 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 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.
Cory H. White contact
Kirk S. Honour study chair
EndoPhotonix, Inc.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Laser MAZE by Ablation of Cardiac Tissue in people with Atrial Fibrillation, run by EndoPhotonix, 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 13 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: status not confirmed, as of the sponsor's last update on 13 Aug 2008. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kirk S. Honour (651-452-3000, khonour@endophotonix.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Freedom from atrial fibrillation by 24-hour 3-lead Holter Monitor at the 180 day evaluation. On or Off Class 1 and III anti-arrhythmic medication (time frame: 180 days). 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 13 Aug 2008.