Atrial FibrillationPhase 2NCT01695824
Left Atrial Appendage (LAA) Occluders After Catheter Ablation of Atrial Fibrillation
A Phase 2 study testing LAA occluder, RFA ablation and Warfarin in people with Atrial Fibrillation, run by Meshalkin Research Institute of Pathology of Circulation at 1 site in Russia.
Trial summary
The primary objective of this study is to assess combined end point (All stroke, Systemic embolism, Cardiovascular death) between two groups. 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?
- LAA occluder, RFA ablation and Warfarin
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 siteRussia
- Study dates
- Dec 2011to Nov 2014
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient has paroxysmal, persistent or permanent non-valvular atrial fibrillation (AF)
- Eligible for long term warfarin
- CHADS score >= 1 (congestive heart failure [CHF], history of high blood pressure, 75 years of age or older, diabetes, prior stroke or transient ischemic attack [TIA])
Who cannot join
- Contraindicated for warfarin
- Contraindicated for aspirin or clopidogrel (Plavix)
- CHF Class 4
- Implanted mechanical valve
- Atrial septal or Patent Foramen Ovale (PFO) device
- Platelets < 100,000 or hemoglobin < 10
- Left ventricular ejection fraction (LVEF) < 30%
Trial locations and contacts
1 site in 1 country.
Russia1 site
State Research Institute of CIrculation Pathology
Novosibirsk, 630055
About this study
Official title: Implantation of Left Atrial Appendage Occluders Concomitantly With Catheter Ablation in Patients With Atrial Fibrillation
The primary objective of this study is to assess combined end point (All stroke, Systemic embolism, Cardiovascular death) between two groups.
- Conditions
- Atrial Fibrillation
- Being tested
- LAA occluder, RFA ablation, Warfarin
- Keywords
- 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.
LAA occluderDevice
Also called Watchman
The procedure is performed under transesophageal echocardiographic (TEE) guidance. After a transseptal puncture is performed, a pigtail catheter is maneuvered into the LAA to perform an LAA angiogram. Through the use of a combination of this angiographic and TEE information, a Watchman device, ranging in size between 21 and 33 mm in diameter, is selected. The device comes prepackaged in a catheter-based delivery system that is advanced into the LAA through a 12F transseptal sheath (outer diameter, 14F). Proper positioning and stability of the device are verified by TEE and angiography before device release.
RFA ablationProcedure or surgery
The left atrium (LA) and pulmonary veins (PVs) were explored through a transseptal approach. Real-time three-dimensional (3D) LA maps were reconstructed by using a nonfluoroscopic navigation system (CARTO, Biosense-Webster Inc.). The ipsilateral left and right PVs were encircled in 1 lesion line by circumferential PV isolation. Radiofrequency energy was delivered at 43◦C, 35 W, 0.5 cm away from the PV ostia at the anterior wall, and was reduced to 43◦C, 30 W, 1 cm away from the PV ostia at the posterior wall, with a saline irrigation speed of 17 mL/min. Each lesion was ablated continuously until the local potential amplitude decreased by >80% or RF energy deliveries exceeded 40 seconds. The endpoint of circumferential PV isolation was PV isolation; this was confirmed when Lasso mapping showed the disappearance of all PV potentials or the dissociation of PV potentials from left atrial activity.
WarfarinDrug
Warfarin was discontinued in 45 days after procedure in case of no trombus by TE for "Watchman group"
All patients in "Warfarin group" continued to receive Warfarin during hole study period with IMR from II to III.
| Study group | Role | What they receive |
|---|---|---|
| LAA occluder | Active comparator | Not described Receives: Device: LAA occluder; Procedure: RFA ablation; Drug: Warfarin |
| Warfarin | Active comparator | Not described Receives: Procedure: RFA ablation; Drug: Warfarin |
What is being measured
The primary outcome is the main question the study is designed to answer.
All stroke
Measured: 12 months
Systemic embolism
Measured: 12 months
Cardiovascular death
Measured: 12 months
Secondary outcomes (4)
Technical success
Measured: 45 days
Procedure success
Measured: 45 days
30 day major adverse event (MAE)
Measured: 30 days
Left atrial appendage (LAA) coverage
Measured: 45 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2012 (estimated)
- Study startDec 2011
- Primary completionNov 2014
- Study completionNov 2014
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
- None (open label)
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- Meshalkin Research Institute of Pathology of Circulation
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Evgeny Pokushalov, MD, PhD, Principal investigator, State Research Institute of Circulation Pathology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01695824
- Sponsor's protocol ID
- WA-PR-AF
- Status last verified
- Jul 2015
- First submitted
- 26 Sep 2012
- Last updated
- 8 Jul 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Romanov A, Pokushalov E, Artemenko S, Yakubov A, Stenin I, Kretov E, Krestianinov O, Grazhdankin I, Risteski D, Karaskov A, Steinberg JS. Does left atrial appendage closure improve the success of pulmonary vein isolation? Results of a randomized clinical trial. J Interv Card Electrophysiol. 2015 Oct;44(1):9-16. doi: 10.1007/s10840-015-0030-4. Epub 2015 Jul 2.
PubMed 26133284
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implantation of Left Atrial Appendage Occluders Concomitantly With Catheter Ablation in Patients With Atrial Fibrillation
- ClinicalTrials.gov ID
- NCT01695824
- Acronym / sponsor ID
- WA-PR-AF
- Conditions
- Atrial Fibrillation
- Keywords
- catheter ablation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- Meshalkin Research Institute of Pathology of CirculationResearch network
- Study start
- Dec 2011
- Primary completion
- Nov 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 28 Sep 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.
The primary objective of this study is to assess combined end point (All stroke, Systemic embolism, Cardiovascular death) between two groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LAA occluder | Active comparator | Device: LAA occluder, Procedure: RFA ablation, Drug: Warfarin |
| Warfarin | Active comparator | Procedure: RFA ablation, Drug: Warfarin |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patient has paroxysmal, persistent or permanent non-valvular atrial fibrillation (AF)
- Eligible for long term warfarin
- CHADS score >= 1 (congestive heart failure [CHF], history of high blood pressure, 75 years of age or older, diabetes, prior stroke or transient ischemic attack [TIA])
Key exclusion criteria (7 listed)
- Contraindicated for warfarin
- Contraindicated for aspirin or clopidogrel (Plavix)
- CHF Class 4
- Implanted mechanical valve
- Atrial septal or Patent Foramen Ovale (PFO) device
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 |
|---|---|---|
| LAA occluderAlso: WatchmanThe procedure is performed under transesophageal echocardiographic (TEE) guidance. After a transseptal puncture is performed, a pigtail catheter is maneuvered into the LAA to perform an LAA angiogram. Through the use of a combination of this angiographic and TEE information, a Watchman device, ranging in size between 21 and 33 mm in diameter, is selected. The device comes prepackaged in a catheter-based delivery system that is advanced into the LAA through a 12F transseptal sheath (outer diameter, 14F). Proper positioning and stability of the device are verified by TEE and angiography before device release. | Device | LAA occluder |
| RFA ablationThe left atrium (LA) and pulmonary veins (PVs) were explored through a transseptal approach. Real-time three-dimensional (3D) LA maps were reconstructed by using a nonfluoroscopic navigation system (CARTO, Biosense-Webster Inc.). The ipsilateral left and right PVs were encircled in 1 lesion line by circumferential PV isolation. Radiofrequency energy was delivered at 43◦C, 35 W, 0.5 cm away from the PV ostia at the anterior wall, and was reduced to 43◦C, 30 W, 1 cm away from the PV ostia at the posterior wall, with a saline irrigation speed of 17 mL/min. Each lesion was ablated continuously until the local potential amplitude decreased by >80% or RF energy deliveries exceeded 40 seconds. The endpoint of circumferential PV isolation was PV isolation; this was confirmed when Lasso mapping showed the disappearance of all PV potentials or the dissociation of PV potentials from left atrial activity. | Procedure or surgery | LAA occluder, Warfarin |
| WarfarinWarfarin was discontinued in 45 days after procedure in case of no trombus by TE for "Watchman group" All patients in "Warfarin group" continued to receive Warfarin during hole study period with IMR from II to III. | Drug | LAA occluder, Warfarin |
Primary outcome
All stroke
Time frame: 12 months
Systemic embolism
Time frame: 12 months
Cardiovascular death
Time frame: 12 months
4 secondary outcomes
Technical success
Time frame: 45 days
Procedure success
Time frame: 45 days
30 day major adverse event (MAE)
Time frame: 30 days
Left atrial appendage (LAA) coverage
Time frame: 45 days
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 8 Jul 2015.
- Derived from this study: PubMed 26133284Romanov A, Pokushalov E, Artemenko S, Yakubov A, Stenin I, Kretov E, Krestianinov O, Grazhdankin I, Risteski D, Karaskov A, Steinberg JS. Does left atrial appendage closure improve the success of pulmonary vein isolation? Results of a randomized clinical trial. J Interv Card Electrophysiol. 2015 Oct;44(1):9-16. doi: 10.1007/s10840-015-0030-4. Epub 2015 Jul 2.
- State Research Institute of Circulation Pathology Official SiteLink provided by the sponsor.
Related trials for Atrial Fibrillation
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Horizon 360 Protocol for the Treatment of Paroxysmal Atrial Fibrillation With the Sphere-360™ Catheter and Affera™ Mapping and Ablation System (Horizon 360)
Paroxysmal AF
Active, not recruitingObservational study
Concomitant Left Atrial Appendage Closure and Pulsed Field Ablation-Asia
Concomitant Procedures, Atrial Fibrillation
Active, not recruiting
CONVERGE Post-Approval Study (PAS)
Chronic Atrial Fibrillation
Recruiting
Early Closure of Left Atrial Appendage for Patients With Atrial Fibrillation and Ischemic Stroke Despite Anticoagulation Therapy
Ischemic Stroke, Atrial Fibrillation
RecruitingPhase 2
Safety in Adult Participants With Atrial Fibrillation Who Are Treated With Anticoagulation
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.
Evgeny Pokushalov, MD, PhD principal investigator
State Research Institute of Circulation Pathology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing LAA occluder, RFA ablation and Warfarin in people with Atrial Fibrillation, run by Meshalkin Research Institute of Pathology of Circulation at 1 site 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 3 inclusion and 7 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 8 Jul 2015. 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 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?
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?
All stroke (time frame: 12 months). The study lists 3 primary outcomes in all. 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 NCT01695824, 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 8 Jul 2015.