Persistent Atrial FibrillationEMMCAFNCT03446222
Epicardial Mini-Maze Versus Catheter Ablation for the Management of Persistent Atrial Fibrillation
A study testing Catheter ablation and Mini-maze surgical procedure in people with Persistent Atrial Fibrillation, run by The University of Texas Health Science Center, Houston at 1 site in United States.
Trial summary
This study will assess the efficacy of catheter ablation versus the Wolf Mini-Maze surgical ablation for rhythm control in patients with persistent afib. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Persistent Atrial Fibrillation
- What is being tested?
- Catheter ablation and Mini-maze surgical procedure
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2016to 18 Dec 2018
- Phase
- Interventional
- 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
- Persistent symptomatic AF with failure of at least 1 anti-arrhythmic drug
- Prior pulmonary vein isolation (PVI)
- CHA2DS2VASC > 0
- Able to tolerate and compliant with oral anticoagulation with either Warfarin, dabigatran, rivoraxaban or apixiban
Who cannot join
- Inability to follow-up as per protocol
- Prior valvular surgery or valve replacement
- Reversible cause for atrial fibrillation
- Currently on dialysis or renal replacement therapy
- Need for concomitant cardiac surgery
- History of MI or stroke ≤2 months prior to ablation
- Intolerance to oral anticoagulants
- Thrombus in the Left atrial appendage
Trial locations and contacts
1 site in 1 country.
United States1 site
The University of Texas Health Science Center at Houston
Houston, Texas, 77030
About this study
This study will assess the efficacy of catheter ablation versus the Wolf Mini-Maze surgical ablation for rhythm control in patients with persistent afib.
Read the detailed description
Higher success rates have been achieved after a single surgical ablation when compared to catheter ablation, however contiguous and transmural lesions are not always guaranteed.
Even though, catheter ablation is now being offered for symptomatic persistent AF, recurrence after the index procedure in such a persistent AF substrate is not unusual. Redo-catheter ablation is routinely offered for such patients; however long term success still remains low. Non-pulmonary vein triggers are often targeted in such redo-catheter ablation procedures; though this approach remains controversial. More recently, the Wolf Mini-Maze procedure has been utilized with promising results.
This study proposes to randomize a group of persistent AF patients to undergo either catheter ablation or the surgical mini-maze procedure with left atrial appendage (LAA) ligation
- Conditions
- Persistent Atrial Fibrillation
- Being tested
- Catheter ablation, Mini-maze surgical procedure
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Catheter ablationProcedure or surgery
Catheter based radiofrequency ablation with wide antral circumferential PVI and isolation of posterior wall will be performed. Mitral and cavo-tricuspid isthmus ablation will be done only if such isthumus dependent flutters are documented prior to / during the procedure.
Mini-maze surgical procedureProcedure or surgery
Wolf Mini-maze surgical ablation along with left atrial appendage ligation will be performed.
| Study group | Role | What they receive |
|---|---|---|
| Catheter Ablation | Active comparator | Catheter based radiofrequency ablation with wide antral circumferential PVI and isolation of posterior wall will be performed. Mitral and cavo-tricuspid isthmus ablation will be done only if such isthumus dependent flutters are documented prior to / during the procedure. Receives: Procedure: Catheter ablation |
| Mini-maze surgical procedure | Active comparator | Wolf Mini-maze surgical ablation along with left atrial appendage ligation will be performed. Receives: Procedure: Mini-maze surgical procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants who are free from atrial fibrillation (AF)
Measured: 12 months after the procedure
Secondary outcomes (4)
Number of participants who experienced a procedural complication
Measured: 2 weeks after the procedure
Number of participants who are at risk of stroke
Measured: 12 months after the procedure
Number of participants who were hospitalized for cardiovascular events
Measured: 12 months after the procedure
AF burden as assessed by the CCA-SAF
AF burden will be assessed using the Canadian Cardiovascular Society - Severity of Atrial Fibrillation Score (CCA-SAF), which provides objective symptoms severity scoring.
Measured: 12 months after the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2018
- Study startJun 2016
- Primary completionDec 2017 (estimated)
- Study completion18 Dec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Persistent Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center, HoustonThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rajesh Venkataraman, MD, Principal investigator, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03446222
- Sponsor's protocol ID
- HSC-MS-15-0880
- Acronym
- EMMCAF
- Status last verified
- Feb 2018
- First submitted
- 20 Feb 2018
- Last updated
- 26 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Epicardial Mini-Maze Versus Catheter Ablation for the Management of Persistent Atrial Fibrillation
- ClinicalTrials.gov ID
- NCT03446222
- Acronym / sponsor ID
- EMMCAF / HSC-MS-15-0880
- Conditions
- Persistent Atrial Fibrillation
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Study start
- Jun 2016
- Primary completion
- Dec 2017 (estimated)
- Study completion
- 18 Dec 2018 (estimated)
- First posted
- 26 Feb 2018 (actual)
- 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.
This study will assess the efficacy of catheter ablation versus the Wolf Mini-Maze surgical ablation for rhythm control in patients with persistent afib.
Detailed description
Higher success rates have been achieved after a single surgical ablation when compared to catheter ablation, however contiguous and transmural lesions are not always guaranteed.
Even though, catheter ablation is now being offered for symptomatic persistent AF, recurrence after the index procedure in such a persistent AF substrate is not unusual. Redo-catheter ablation is routinely offered for such patients; however long term success still remains low. Non-pulmonary vein triggers are often targeted in such redo-catheter ablation procedures; though this approach remains controversial. More recently, the Wolf Mini-Maze procedure has been utilized with promising results.
This study proposes to randomize a group of persistent AF patients to undergo either catheter ablation or the surgical mini-maze procedure with left atrial appendage (LAA) ligation
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Catheter Ablation | Active comparator | Procedure: Catheter ablationCatheter based radiofrequency ablation with wide antral circumferential PVI and isolation of posterior wall will be performed. Mitral and cavo-tricuspid isthmus ablation will be done only if such isthumus dependent flutters are documented prior to / during the procedure. |
| Mini-maze surgical procedure | Active comparator | Procedure: Mini-maze surgical procedureWolf Mini-maze surgical ablation along with left atrial appendage ligation will be performed. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Persistent symptomatic AF with failure of at least 1 anti-arrhythmic drug
- Prior pulmonary vein isolation (PVI)
- CHA2DS2VASC > 0
- Able to tolerate and compliant with oral anticoagulation with either Warfarin, dabigatran, rivoraxaban or apixiban
Key exclusion criteria (8 listed)
- Inability to follow-up as per protocol
- Prior valvular surgery or valve replacement
- Reversible cause for atrial fibrillation
- Currently on dialysis or renal replacement therapy
- Need for concomitant cardiac surgery
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 |
|---|---|---|
| Catheter ablationCatheter based radiofrequency ablation with wide antral circumferential PVI and isolation of posterior wall will be performed. Mitral and cavo-tricuspid isthmus ablation will be done only if such isthumus dependent flutters are documented prior to / during the procedure. | Procedure or surgery | Catheter Ablation |
| Mini-maze surgical procedureWolf Mini-maze surgical ablation along with left atrial appendage ligation will be performed. | Procedure or surgery | Mini-maze surgical procedure |
Primary outcome
Number of participants who are free from atrial fibrillation (AF)
Time frame: 12 months after the procedure
4 secondary outcomes
Number of participants who experienced a procedural complication
Time frame: 2 weeks after the procedure
Number of participants who are at risk of stroke
Time frame: 12 months after the procedure
Number of participants who were hospitalized for cardiovascular events
Time frame: 12 months after the procedure
AF burden as assessed by the CCA-SAF
Time frame: 12 months after the procedure
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2018.
- Individual participant dataSharing planned: No
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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.
Rajesh Venkataraman, MD principal investigator
The University of Texas Health Science Center, Houston
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Catheter ablation and Mini-maze surgical procedure in people with Persistent Atrial Fibrillation, run by The University of Texas Health Science Center, Houston at 1 site 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 4 inclusion and 8 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: withdrawn, as of the sponsor's last update on 26 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 was withdrawn before enrolling participants, so there are no results.
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 participants who are free from atrial fibrillation (AF) (time frame: 12 months after the procedure). 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 26 Feb 2018; AzTrials last refreshed its copy on 7 Nov 2026.