Atrial FibrillationStaged DEEPNCT01661205
Dual Epicardial Endocardial Persistent Atrial Fibrillation(AF) Study (Staged DEEP)
A study testing Ablation procedure staged catheter ablation in people with Atrial Fibrillation, run by AtriCure, Inc. at 6 sites in 3 countries.
Trial summary
The purpose of this study is to assess the safety and technical feasibility of treating subjects with Persistent Atrial Fibrillation or Longstanding Persistent Atrial Fibrillation in a minimally invasive thoracoscopic ablation procedure utilizing the AtriCure Bipolar System, with mapping and additional lesion… 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?
- Ablation procedure staged catheter ablation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 6 sitesin 3 countries
- Study dates
- Aug 2012to Dec 2015
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age > 18 year
- Patients with symptomatic persistent or longstanding persistent AF refractory to a minimum of one Class I or III antiarrhythmic drug (AAD).
- Patients with failed catheter ablation attempts are eligible if the patients are symptomatic with persistent or longstanding persistent AF. (catheter ablation procedure must be more than 3 months prior to index procedure)
- Life expectancy of at least two years
- Patient will and able to provide informed consent
- Patient is willing and able to attend the scheduled follow-up visits
Who cannot join
- Prior Cardiothoracic Surgery
- Patient has NYHA (New York Heart Association) Class IV heart failure
- Evidence of underlying structural heart disease requiring surgical treatment
- Surgical procedure within the 30 days prior to the index procedure
- Ejection fraction < 30%
- Measured left atrial diameter > 6.0 cm
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- Renal Failure
- Stroke within previous 6 months
- Known carotid artery stenosis greater than 80%
- Evidence of significant active infection or endocarditis
- Pregnant woman or women desiring to become pregnant in the next 24 months
- Presence of thrombus in the left atrium determined by echocardiography
- History of blood dyscrasia
- Contraindication to anticoagulation, based on Investigator's opinion
- Mural thrombus or tumor
- Moderate to Severe COPD
Trial locations and contacts
6 sites in 3 countries.
6 sites in 3 countries
United States4 sites
Colorado Springs Cardiology/Colorado Cardiac Alliance
Colorado Springs, Colorado, 80907
Vanderbilt Heart Institute
Nashville, Tennessee, 37232
Sentara Norfolk Hospital
Norfolk, Virginia, 23507
Stanford University Medical Center
Stanford, California, 94305
About this study
Official title: Feasibility Trial of a Staged Epicardial & Endocardial Approach for Treatment of Patients With Persistent or Long Standing Persistent Atrial Fibrillation With Radiofrequency Ablation
The purpose of this study is to assess the safety and technical feasibility of treating subjects with Persistent Atrial Fibrillation or Longstanding Persistent Atrial Fibrillation in a minimally invasive thoracoscopic ablation procedure utilizing the AtriCure Bipolar System, with mapping and additional lesion creation/ gap closure (as needed) provided by currently approved catheter technology, when the epicardial and endocardial phases are performed in a staged manner within 1-10 days apart, during the same hospitalization.
Read the detailed description
The purpose of this clinical investigation is to evaluate how safe a less invasive cardiac surgery using the AtriCure Bipolar System in conjunction with a catheter ablation procedure performed approximately 1-10 days after, in treating atrial fibrillation, and how effective is this staged procedure. The AtriCure Bipolar System will be used to perform the less invasive cardiac surgery and a standard electrophysiology catheter, currently available, will be used to perform the catheter ablation procedure. This surgical procedure is considered less invasive because it is done through tiny surgical punctures on the sides of the chest near the ribs instead of one large surgical incision of the breast bone to completely open the chest and access the heart, and it also avoids the need for the heart-lung bypass machine.
- Conditions
- Atrial Fibrillation
- Being tested
- Ablation procedure staged catheter ablation
- Keywords
- Persistent AF, Longstanding Persistent AF, Ablation, catheter ablation
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ablation procedure staged catheter ablationDevice
AtriCure Bipolar System used in conjunction with a catheter ablation procedure performed 1-10 days apart
| Study group | Role | What they receive |
|---|---|---|
| AtriCure Bipolar System combined with a catheter ablation | Experimental | Minimally invasive procedure using the AtriCure Bipolar System plus a catheter ablation performed approximately 1-10 days apart Receives: Device: Ablation procedure staged catheter ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Patients With Pre-specified Safety Endpoints Occurring in the First 30 Days Post-index Procedure or Hospital Discharge, Whichever is Longer.
Pre-specified events include: Death; Myocardial Infarction; Stroke or TIA; Excess bleeding; Pulmonary vein stenosis; atrio-esophagael fistula; phrenic nerve paralysis; Pericardial effusion; Embolisms.
Measured: 30 days post-index procedure or hospital discharge
Number of Subjects With Absence of Atrial Fibrillation
Absence of atrial fibrillation (AF) at twelve month follow-up based on continuous 14 day ECG monitoring, while off all Class I and III antiarrhythmic therapy.
Measured: 12 month follow-up
Secondary outcomes (6)
Number Subjects With Serious Device or Procedure Related Adverse Event Rate
Measured: 12 month follow-up
Number of Subjects With Acute Procedure Success
Defined as subject meeting all of the following criteria upon completion of the index-EP procedure
- Isolation/block of all pulmonary veins (e.g. 4 of 4 veins);
- Bi-directional cavotricuspid isthmus block;
- Isolation of Box (i.e. no capture outside ablation lines connecting roof and floor lines between right-and-left pulmonary vein isolation lines);
- Superior Vena Cava (SVC) isolation, if encircling SVC lesion performed.
Measured: Day 0
Number of Subject Without Atrial Fibrillation
AF free with or without the need of antiarrhythmic drugs
Measured: 6 and 12 month follow-up
Number of Subjects With Reinterventions
Measured: 12 month follow-up
Number of Subjects With Direct Current (DC) Cardioversion
Measured: 12 month follow-up
Change in AF Based on AF Symptoms Checklist Frequency and Severity Scores
Change in Atrial Fibrillation Symptom Checklist Frequency and Severity Scores. This is reported as change from Baseline.
- This scale has 16 items to assess frequency of occurrence on a scale: Never; Rarely; Sometimes; Often; Always. These rating correspond to numerical values of: 1, 2, 3, 4, and 5, respectively. AF Frequency range from 0 to 80 . Higher scores indicating greater symptomatology.
- The same items are also used to assess severity on a scale: Mild; Moderate; Severe. Corresponding to 1, 2, and 3, respectively. AF Severity score range from 0 to 48. Higher scores indicating greater symptomatology.
- Negative change from baseline compared to 12-months represents an improvement in AF symptomatology .
Measured: 12 month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2012 (estimated)
- Study startAug 2012
- Primary completionDec 2015
- Study completionDec 2015
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.
- 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
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- AtriCure, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01661205
- Sponsor's protocol ID
- CP2012-1
- Acronym
- Staged DEEP
- Status last verified
- Apr 2017
- First submitted
- 11 Jul 2012
- Last updated
- 17 May 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Trial of a Staged Epicardial & Endocardial Approach for Treatment of Patients With Persistent or Long Standing Persistent Atrial Fibrillation With Radiofrequency Ablation
- ClinicalTrials.gov ID
- NCT01661205
- Acronym / sponsor ID
- Staged DEEP / CP2012-1
- Conditions
- Atrial Fibrillation
- Keywords
- Persistent AF, Longstanding Persistent AF, Ablation, catheter ablation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- AtriCure, Inc.Industry (pharma, biotech, devices)
- Study start
- Aug 2012
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 9 Aug 2012 (estimated)
- Results
- Posted 17 May 2017
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 assess the safety and technical feasibility of treating subjects with Persistent Atrial Fibrillation or Longstanding Persistent Atrial Fibrillation in a minimally invasive thoracoscopic ablation procedure utilizing the AtriCure Bipolar System, with mapping and additional lesion creation/ gap closure (as needed) provided by currently approved catheter technology, when the epicardial and endocardial phases are performed in a staged manner within 1-10 days apart, during the same hospitalization.
Detailed description
The purpose of this clinical investigation is to evaluate how safe a less invasive cardiac surgery using the AtriCure Bipolar System in conjunction with a catheter ablation procedure performed approximately 1-10 days after, in treating atrial fibrillation, and how effective is this staged procedure. The AtriCure Bipolar System will be used to perform the less invasive cardiac surgery and a standard electrophysiology catheter, currently available, will be used to perform the catheter ablation procedure. This surgical procedure is considered less invasive because it is done through tiny surgical punctures on the sides of the chest near the ribs instead of one large surgical incision of the breast bone to completely open the chest and access the heart, and it also avoids the need for the heart-lung bypass machine.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AtriCure Bipolar System combined with a catheter ablation | Experimental | Device: Ablation procedure staged catheter ablationMinimally invasive procedure using the AtriCure Bipolar System plus a catheter ablation performed approximately 1-10 days apart |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age > 18 year
- Patients with symptomatic persistent or longstanding persistent AF refractory to a minimum of one Class I or III antiarrhythmic drug (AAD).
- Patients with failed catheter ablation attempts are eligible if the patients are symptomatic with persistent or longstanding persistent AF. (catheter ablation procedure must be more than 3 months prior to index procedure)
- Life expectancy of at least two years
- Patient will and able to provide informed consent
Key exclusion criteria (16 listed)
- Prior Cardiothoracic Surgery
- Patient has NYHA (New York Heart Association) Class IV heart failure
- Evidence of underlying structural heart disease requiring surgical treatment
- Surgical procedure within the 30 days prior to the index procedure
- Ejection fraction < 30%
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 |
|---|---|---|
| Ablation procedure staged catheter ablationAtriCure Bipolar System used in conjunction with a catheter ablation procedure performed 1-10 days apart | Device | AtriCure Bipolar System combined with a catheter ablation |
Primary outcome
Number of Patients With Pre-specified Safety Endpoints Occurring in the First 30 Days Post-index Procedure or Hospital Discharge, Whichever is Longer.
Time frame: 30 days post-index procedure or hospital discharge
Pre-specified events include: Death; Myocardial Infarction; Stroke or TIA; Excess bleeding; Pulmonary vein stenosis; atrio-esophagael fistula; phrenic nerve paralysis; Pericardial effusion; Embolisms.
Number of Subjects With Absence of Atrial Fibrillation
Time frame: 12 month follow-up
Absence of atrial fibrillation (AF) at twelve month follow-up based on continuous 14 day ECG monitoring, while off all Class I and III antiarrhythmic therapy.
6 secondary outcomes
Number Subjects With Serious Device or Procedure Related Adverse Event Rate
Time frame: 12 month follow-up
Number of Subjects With Acute Procedure Success
Time frame: Day 0
Number of Subject Without Atrial Fibrillation
Time frame: 6 and 12 month follow-up
Number of Subjects With Reinterventions
Time frame: 12 month follow-up
Number of Subjects With Direct Current (DC) Cardioversion
Time frame: 12 month follow-up
Change in AF Based on AF Symptoms Checklist Frequency and Severity Scores
Time frame: 12 month follow-up
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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ATRIAL APPENDAGE CLOSURE for ATRIAL FIBRILLATION, 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.
6 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ablation procedure staged catheter ablation in people with Atrial Fibrillation, run by AtriCure, Inc. at 6 sites in 3 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 6 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: finished, as of the sponsor's last update on 17 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States, Belgium, Netherlands. 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 17 May 2017). 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?
Number of Patients With Pre-specified Safety Endpoints Occurring in the First 30 Days Post-index Procedure or Hospital Discharge, Whichever is Longer. (time frame: 30 days post-index procedure or hospital discharge). 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 May 2017.