Atrial Fibrillation AblationSAVEDNCT01034852
Efficacy Study for Surgery After Previous Failed Catheter Ablation
An observational study of Atrial Fibrillation Ablation, run by Cardiopulmonary Research Science and Technology Institute at 2 sites in United States.
Trial summary
Specific Aims: The primary objective of this registry is to determine the percentage of patients who are free from atrial fibrillation (AF) at 6 and 12 months following a surgical ablation procedure when the patient has a history of failing one or more previous catheter based ablations for AF. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation Ablation
- What is being tested?
- Totally Thoracoscopic Maze
- Type of treatment
- Surgery or procedure
- How many people
- 45 participants
- Where
- 2 sitesUnited States
- Study dates
- May 2009to Jan 2011
- Phase
- Observational
- 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
Study population: Patients that have undergone surgical ablation after failing catheter based ablation at investigator sites
Who may be able to join
- Diagnosis of atrial fibrillation
- Has undergone one or more catheter based ablation procedures for AF and the procedure failed
- Has undergone a minimal access surgical ablation procedure for the treatment of AF following failure of catheter based ablation for AF
Who cannot join
None listed.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Cardiopulmonary Research Science and Technology Institute
Dallas, Texas, 75230
Endovascular Research
Springfield, Oregon, 97477
About this study
Official title: Surgery After Previous Failed Catheter Ablation
Specific Aims: The primary objective of this registry is to determine the percentage of patients who are free from atrial fibrillation (AF) at 6 and 12 months following a surgical ablation procedure when the patient has a history of failing one or more previous catheter based ablations for AF. The first 3 months following surgical ablation will be a blanking period; any arrhythmia occurring during this time will not be used to determine success.
Primary Objectives:
Read more
- Determine the percent success of surgical ablation for AF at 6, and 12 months both on and off of antiarrhythmic drugs (AAD) following a failed catheter based ablation for AF
- Record and evaluate all complications associated with the surgical procedure.
Secondary Objectives:
- Evaluate usage of anticoagulants at 6, and 12 months.
- Determine the percentage of Pulmonary Veins (PV) that were electrically isolated by intra-operative, pre-surgical mapping
- Conditions
- Atrial Fibrillation Ablation
- Being tested
- Totally Thoracoscopic Maze
- Keywords
- Atrial Fibrillation, Maze, 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.
Totally Thoracoscopic MazeProcedure or surgery
Also called Minimally invasive maze, Cox Maze procedure
Epicardial pulmonary vein isolation with additional lesions as determined to be necessary by physician
| Study group | Role | What they receive |
|---|---|---|
| Surgical ablation | Patients undergoing surgical ablation for Atrial Fibrillation that have failed one or more previous attempts at catheter ablation for Atrial Fibrillation Receives: Procedure: Totally Thoracoscopic Maze |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine the efficacy of surgical ablation for AF at 6, & 12 months both on and off of antiarrhythmic drugs following a failed catheter based ablation for AF.
Measured: 1 year post operatively
Record and evaluate all complications associated with the surgical procedure.
Measured: 1 year post operatively
Secondary outcomes (2)
Evaluate usage of anticoagulants at 6 and 12 months.
Measured: 1 year post operatively
Determine the % of Pulmonary Veins that were electrically isolated by intra-operative, pre-surgical mapping.
Measured: 1 year post operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2009 (estimated)
- Study startMay 2009
- Primary completionJan 2011
- Study completionJan 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial Fibrillation AblationStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cardiopulmonary Research Science and Technology Institute
- Sponsor type
- University, hospital or other
- Collaborators
- AtriCure, Inc., Virginia Commonwealth University
- Responsible party
- Sponsor
- Investigators
- James R Edgerton, MD, Principal investigator, Cardiopulmonary Research Science and Technology Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01034852
- Sponsor's protocol ID
- 09.018
- Acronym
- SAVED
- Status last verified
- Feb 2012
- First submitted
- 17 Dec 2009
- Last updated
- 22 Feb 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Surgery After Previous Failed Catheter Ablation
- ClinicalTrials.gov ID
- NCT01034852
- Acronym / sponsor ID
- SAVED / 09.018
- Conditions
- Atrial Fibrillation Ablation
- Keywords
- Atrial Fibrillation, Maze, Ablation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Cardiopulmonary Research Science and Technology InstituteUniversity, hospital or other
- Collaborators
- AtriCure, Inc., Virginia Commonwealth University
- Study start
- May 2009
- Primary completion
- Jan 2011 (actual)
- Study completion
- Jan 2011 (actual)
- First posted
- 18 Dec 2009 (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.
Specific Aims: The primary objective of this registry is to determine the percentage of patients who are free from atrial fibrillation (AF) at 6 and 12 months following a surgical ablation procedure when the patient has a history of failing one or more previous catheter based ablations for AF. The first 3 months following surgical ablation will be a blanking period; any arrhythmia occurring during this time will not be used to determine success.
Primary Objectives:
- Determine the percent success of surgical ablation for AF at 6, and 12 months both on and off of antiarrhythmic drugs (AAD) following a failed catheter based ablation for AF
- Record and evaluate all complications associated with the surgical procedure.
Secondary Objectives:
- Evaluate usage of anticoagulants at 6, and 12 months.
- Determine the percentage of Pulmonary Veins (PV) that were electrically isolated by intra-operative, pre-surgical mapping
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Surgical ablation | – | Procedure: Totally Thoracoscopic MazePatients undergoing surgical ablation for Atrial Fibrillation that have failed one or more previous attempts at catheter ablation for Atrial Fibrillation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients that have undergone surgical ablation after failing catheter based ablation at investigator sites
Key inclusion criteria (3 listed)
- Diagnosis of atrial fibrillation
- Has undergone one or more catheter based ablation procedures for AF and the procedure failed
- Has undergone a minimal access surgical ablation procedure for the treatment of AF following failure of catheter based ablation for AF
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Totally Thoracoscopic MazeAlso: Minimally invasive maze, Cox Maze procedureEpicardial pulmonary vein isolation with additional lesions as determined to be necessary by physician | Procedure or surgery | Surgical ablation |
Primary outcome
Determine the efficacy of surgical ablation for AF at 6, & 12 months both on and off of antiarrhythmic drugs following a failed catheter based ablation for AF.
Time frame: 1 year post operatively
Record and evaluate all complications associated with the surgical procedure.
Time frame: 1 year post operatively
2 secondary outcomes
Evaluate usage of anticoagulants at 6 and 12 months.
Time frame: 1 year post operatively
Determine the % of Pulmonary Veins that were electrically isolated by intra-operative, pre-surgical mapping.
Time frame: 1 year post operatively
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2012.
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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.
James R Edgerton, MD principal investigator
Cardiopulmonary Research Science and Technology Institute
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atrial Fibrillation Ablation, run by Cardiopulmonary Research Science and Technology Institute at 2 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 3 inclusion and 0 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 22 Feb 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Determine the efficacy of surgical ablation for AF at 6, & 12 months both on and off of antiarrhythmic drugs following a failed catheter based ablation for AF. (time frame: 1 year post operatively). 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 22 Feb 2012.