Atrial FibrillationPhase 2NCT02562391
Effect of Left Atrial Appendage Excision on Procedure Outcome in Patients With Persistent and Long-standing Persistent Atrial Fibrillation Undergoing Surgical Ablation
A Phase 2 study testing Surgical ablation of the left atrium (PVI+Box lesions) and Surgical ablation of the left atrium (PVI+Box lesions) and left atrial appendage cutting in people with Atrial Fibrillation, run by Meshalkin Research Institute of Pathology of Circulation at 4 sites in Russia.
Trial summary
The aim of this study is to assess the effect of left atrial appendage excision on atrial fibrillation recurrence and incidence of stroke in patients with persistent and long-standing persistent atrial fibrillation undergoing surgical ablation. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- Surgical ablation of the left atrium (PVI+Box lesions) and Surgical ablation of the left atrium (PVI+Box lesions) and left atrial appendage cutting
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 4 sitesRussia
- Study dates
- May 2011to May 2017
- Phase
- Phase 2
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with persistent and long-standing persistent atrial fibrillation eligible for thoracoscopy surgical ablation
- Signed inform consent
Who cannot join
- Paroxysmal atrial fibrillation
- Contraindications for surgical ablation
- Unwilling to participate
Trial locations and contacts
4 sites in 1 country.
Russia4 sites
Federal Center of Cardiovascular surgery
Krasnoyarsk
Federal State Institution Clinical Hospital of the Presidental Administration of the RF
Moscow
Scientific center of the cardiovascular surgery named by A.N. Bakulev
Moscow
State Research Institute of CIrculation Pathology
Novosibirsk, 630055
About this study
The aim of this study is to assess the effect of left atrial appendage excision on atrial fibrillation recurrence and incidence of stroke in patients with persistent and long-standing persistent atrial fibrillation undergoing surgical ablation.
- Conditions
- Atrial Fibrillation
- Being tested
- Surgical ablation of the left atrium (PVI+Box lesions), Surgical ablation of the left atrium (PVI+Box lesions) and left atrial appendage cutting
- Keywords
- atrial fibrillation, ablation, thoracoscopy, left atrial appendage
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surgical ablation of the left atrium (PVI+Box lesions)Device
Surgical ablation of the left atrium (PVI+Box lesions) and left atrial appendage cuttingDevice
| Study group | Role | What they receive |
|---|---|---|
| PVI+Box lesions | Active comparator | Patients were treated with video-assisted thoracoscopy under general anesthesia, according to a previously described protocol. In brief, PVI was performed from the epicardial side with a bipolar radiofrequency ablation clamp. At least 2 overlapping applications around each of the ipsilateral veins were made, and isolation was confirmed by the absence of PV potentials and exit block during pacing. In addition to PVI, the bilateral epicardial ganglia were found by high-frequency stimulation and ablated, as confirmed by the absence of a vagal response after ablation. Finally additional lines were made to create a posterior box lesion. Sensing and pacing maneuvers verified isolation of the posterior box. Receives: Device: Surgical ablation of the left atrium (PVI+Box lesions) |
| PVI+Box lesions+LAA cutting | Experimental | Patients were treated with video-assisted thoracoscopy under general anesthesia, according to a previously described protocol. In brief, PVI was performed from the epicardial side with a bipolar radiofrequency ablation clamp. At least 2 overlapping applications around each of the ipsilateral veins were made, and isolation was confirmed by the absence of PV potentials and exit block during pacing. In addition to PVI, the bilateral epicardial ganglia were found by high-frequency stimulation and ablated, as confirmed by the absence of a vagal response after ablation. Finally additional lines were made to create a posterior box lesion. Sensing and pacing maneuvers verified isolation of the posterior box.The left atrial appendage was removed by stapling and then cutting. Receives: Device: Surgical ablation of the left atrium (PVI+Box lesions) and left atrial appendage cutting |
What is being measured
The primary outcome is the main question the study is designed to answer.
Atrial fibrillation recurrences
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2015 (estimated)
- Study startMay 2011
- Primary completionMay 2015
- Study completionMay 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Meshalkin Research Institute of Pathology of Circulation
- Sponsor type
- Research network
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02562391
- Sponsor's protocol ID
- 9872TLAA
- Status last verified
- Sep 2015
- First submitted
- 24 Sep 2015
- Last updated
- 29 Sep 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Romanov A, Pokushalov E, Elesin D, Bogachev-Prokophiev A, Ponomarev D, Losik D, Bayramova S, Strelnikov A, Shabanov V, Pidanov O, Kropotkin E, Ivanickii E, Karaskov A, Steinberg JS. Effect of left atrial appendage excision on procedure outcome in patients with persistent atrial fibrillation undergoing surgical ablation. Heart Rhythm. 2016 Sep;13(9):1803-9. doi: 10.1016/j.hrthm.2016.05.012. Epub 2016 May 12.
PubMed 27180620
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Left Atrial Appendage Excision on Procedure Outcome in Patients With Persistent and Long-standing Persistent Atrial Fibrillation Undergoing Surgical Ablation
- ClinicalTrials.gov ID
- NCT02562391
- Acronym / sponsor ID
- 9872TLAA
- Conditions
- Atrial Fibrillation
- Keywords
- atrial fibrillation, ablation, thoracoscopy, left atrial appendage
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Meshalkin Research Institute of Pathology of CirculationResearch network
- Study start
- May 2011
- Primary completion
- May 2015 (actual)
- Study completion
- May 2017 (estimated)
- First posted
- 29 Sep 2015 (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 aim of this study is to assess the effect of left atrial appendage excision on atrial fibrillation recurrence and incidence of stroke in patients with persistent and long-standing persistent atrial fibrillation undergoing surgical ablation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PVI+Box lesions | Active comparator | Device: Surgical ablation of the left atrium (PVI+Box lesions)Patients were treated with video-assisted thoracoscopy under general anesthesia, according to a previously described protocol. In brief, PVI was performed from the epicardial side with a bipolar radiofrequency ablation clamp. At least 2 overlapping applications around each of the ipsilateral veins were made, and isolation was confirmed by the absence of PV potentials and exit block during pacing. In addition to PVI, the bilateral epicardial ganglia were found by high-frequency stimulation and ablated, as confirmed by the absence of a vagal response after ablation. Finally additional lines were made to create a posterior box lesion. Sensing and pacing maneuvers verified isolation of the posterior box. |
| PVI+Box lesions+LAA cutting | Experimental | Device: Surgical ablation of the left atrium (PVI+Box lesions) and left atrial appendage cuttingPatients were treated with video-assisted thoracoscopy under general anesthesia, according to a previously described protocol. In brief, PVI was performed from the epicardial side with a bipolar radiofrequency ablation clamp. At least 2 overlapping applications around each of the ipsilateral veins were made, and isolation was confirmed by the absence of PV potentials and exit block during pacing. In addition to PVI, the bilateral epicardial ganglia were found by high-frequency stimulation and ablated, as confirmed by the absence of a vagal response after ablation. Finally additional lines were made to create a posterior box lesion. Sensing and pacing maneuvers verified isolation of the posterior box.The left atrial appendage was removed by stapling and then cutting. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with persistent and long-standing persistent atrial fibrillation eligible for thoracoscopy surgical ablation
- Signed inform consent
Key exclusion criteria (3 listed)
- Paroxysmal atrial fibrillation
- Contraindications for surgical ablation
- Unwilling to participate
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 |
|---|---|---|
| Surgical ablation of the left atrium (PVI+Box lesions) | Device | PVI+Box lesions |
| Surgical ablation of the left atrium (PVI+Box lesions) and left atrial appendage cutting | Device | PVI+Box lesions+LAA cutting |
Primary outcome
Atrial fibrillation recurrences
Time frame: 18 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2015.
- Derived from this study: PubMed 27180620Romanov A, Pokushalov E, Elesin D, Bogachev-Prokophiev A, Ponomarev D, Losik D, Bayramova S, Strelnikov A, Shabanov V, Pidanov O, Kropotkin E, Ivanickii E, Karaskov A, Steinberg JS. Effect of left atrial appendage excision on procedure outcome in patients with persistent atrial fibrillation undergoing surgical ablation. Heart Rhythm. 2016 Sep;13(9):1803-9. doi: 10.1016/j.hrthm.2016.05.012. Epub 2016 May 12.
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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.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Surgical ablation of the left atrium (PVI+Box lesions) and Surgical ablation of the left atrium (PVI+Box lesions) and left atrial appendage cutting in people with Atrial Fibrillation, run by Meshalkin Research Institute of Pathology of Circulation at 4 sites in Russia.
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 2 inclusion and 3 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 29 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Russia. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
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 recurrences (time frame: 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02562391, which also lists 1 linked publication.
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 29 Sep 2015.