Atrial FibrillationSHAFTNCT01582828
Serial Hybrid Atrial Fibrillation Ablation
A study testing Epicardial (surgical) ablation and Hybrid in people with Atrial Fibrillation, run by Medisch Spectrum Twente at 1 site in Netherlands.
Trial summary
Treatment of (long-standing) persistent atrial fibrillation (AF) remains cumbersome and the surgical (epicardial) approach seems to be the most effective. Still, however a significant amount of failures exist which is mostly due to incompleteness of the surgical ablation lines. 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?
- Epicardial (surgical) ablation and Hybrid
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteNetherlands
- Study dates
- Aug 2012to Dec 2017
- 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
- patients are screened and accepted for pulmonary vein isolation according to the current guidelines
- long standing persistent or persistent AF as defined in the guidelines
- left atrial size needs to be more than >46 mm on long axis or >35 cc/m2
- CHADSVASC score should be more than 0 as an indicator of a substantial substrate for atrial fibrillation.
Who cannot join
- Significant coronary artery disease has to be excluded as a trigger for AF by means of cardiac CT, if necessary a coronary angiogram will be performed.
- Previous PVI ablation (epicardial or endocardial) or cardiac surgery.
- Significant valvular disease present on echo.
- Concomitant cardiac surgery needed.
Trial locations and contacts
1 site in 1 country.
About this study
Treatment of (long-standing) persistent atrial fibrillation (AF) remains cumbersome and the surgical (epicardial) approach seems to be the most effective. Still, however a significant amount of failures exist which is mostly due to incompleteness of the surgical ablation lines. Checking, and if necessary additional ablation, of these lines afterwards endocardially by the cardiologist (the so-called serial hybrid approach) could overcome this problem.
- Conditions
- Atrial Fibrillation
- Being tested
- Epicardial (surgical) ablation, Hybrid
- Keywords
- atrial, fibrillation, pvi, vats, ablation, hybrid
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Epicardial (surgical) ablationProcedure or surgery
- Pulmonary vein isolation with bipolar clamps and bipolar box lesion
- Epicardial atrial appendage closure
HybridProcedure or surgery
Epicardial (surgical) ablation
- Pulmonary vein isolation with bipolar clamps and bipolar box lesion
- Epicardial atrial appendage closure
Endocardial assessment after 6-8 weeks, checking for isolation and if necessary touch up by RF ablation
| Study group | Role | What they receive |
|---|---|---|
| Epicardial (surgical) ablation | Active comparator | Epicardial Pulmonary vein isolation Receives: Procedure: Epicardial (surgical) ablation |
| Hybrid | Experimental | Epicardial (surgical) ablation \& Endocardial assessment Receives: Procedure: Hybrid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Atrial fibrillation Freedom
left sided atrial flutter and left atrial tachycardia
Measured: 12 months
Secondary outcomes (4)
re-isolation
number of pulmonary veins needing re-isolation by the EP
Measured: 8-10 weeks
Percentage of cross-over
Percentage of cross-over from the surgical arm alone to surgery and serial hybrid ablation.
Measured: 1 year
Complications
Number of complications and thrombo-embolic events in both groups
Measured: 1 year
Atrial fibrillation Burden
Burden of AF in both groups if AF is still present.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2012 (estimated)
- Study startAug 2012
- Primary completionDec 2016 (estimated)
- Study completionDec 2017 (estimated)
Why it stopped: Logistical problems
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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medisch Spectrum Twente
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, B. Oude Velthuis, Medisch Spectrum Twente
- Investigators
- Jurren van Opstal, MD PhD, Principal investigator, Medisch Spectrum Twente
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01582828
- Sponsor's protocol ID
- SHAFT-01
- Acronym
- SHAFT
- Status last verified
- Nov 2024
- First submitted
- 20 Apr 2012
- Last updated
- 22 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Serial Hybrid Atrial Fibrillation Ablation
- ClinicalTrials.gov ID
- NCT01582828
- Acronym / sponsor ID
- SHAFT / SHAFT-01
- Conditions
- Atrial Fibrillation
- Keywords
- atrial, fibrillation, pvi, vats, ablation, hybrid
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Logistical problems
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Medisch Spectrum TwenteUniversity, hospital or other
- Study start
- Aug 2012
- Primary completion
- Dec 2016 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 23 Apr 2012 (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.
Treatment of (long-standing) persistent atrial fibrillation (AF) remains cumbersome and the surgical (epicardial) approach seems to be the most effective. Still, however a significant amount of failures exist which is mostly due to incompleteness of the surgical ablation lines. Checking, and if necessary additional ablation, of these lines afterwards endocardially by the cardiologist (the so-called serial hybrid approach) could overcome this problem.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Epicardial (surgical) ablation | Active comparator | Procedure: Epicardial (surgical) ablationEpicardial Pulmonary vein isolation |
| Hybrid | Experimental | Procedure: HybridEpicardial (surgical) ablation \& Endocardial assessment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- patients are screened and accepted for pulmonary vein isolation according to the current guidelines
- long standing persistent or persistent AF as defined in the guidelines
- left atrial size needs to be more than >46 mm on long axis or >35 cc/m2
- CHADSVASC score should be more than 0 as an indicator of a substantial substrate for atrial fibrillation.
Key exclusion criteria (4 listed)
- Significant coronary artery disease has to be excluded as a trigger for AF by means of cardiac CT, if necessary a coronary angiogram will be performed.
- Previous PVI ablation (epicardial or endocardial) or cardiac surgery.
- Significant valvular disease present on echo.
- Concomitant cardiac surgery needed.
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 |
|---|---|---|
| Epicardial (surgical) ablation* Pulmonary vein isolation with bipolar clamps and bipolar box lesion * Epicardial atrial appendage closure | Procedure or surgery | Epicardial (surgical) ablation |
| HybridEpicardial (surgical) ablation * Pulmonary vein isolation with bipolar clamps and bipolar box lesion * Epicardial atrial appendage closure Endocardial assessment after 6-8 weeks, checking for isolation and if necessary touch up by RF ablation | Procedure or surgery | Hybrid |
Primary outcome
Atrial fibrillation Freedom
Time frame: 12 months
left sided atrial flutter and left atrial tachycardia
4 secondary outcomes
re-isolation
Time frame: 8-10 weeks
Percentage of cross-over
Time frame: 1 year
Complications
Time frame: 1 year
Atrial fibrillation Burden
Time frame: 1 year
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 22 Nov 2024.
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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.
Jurren van Opstal, MD PhD principal investigator
Medisch Spectrum Twente
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Epicardial (surgical) ablation and Hybrid in people with Atrial Fibrillation, run by Medisch Spectrum Twente at 1 site in Netherlands.
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 4 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 22 Nov 2024. 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 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?
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?
Atrial fibrillation Freedom (time frame: 12 months). 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 Nov 2024.