Atrial FibrillationPhase 3NCT01164319
"UNMASKING Study" For Atrial Fibrillation Recurrences Typing in Early Postoperative Period
A Phase 3 study testing Circumferential PVI and subcutaneous cardiac monitor implantation in people with Atrial Fibrillation, run by Meshalkin Research Institute of Pathology of Circulation at 1 site in Russia.
Trial summary
The aim of this study is to identify the most appropriate method for managing patients with AF recurrences after the first ablation procedure, through the diagnostic data stored by a subcutaneous AF monitor. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- Circumferential PVI and subcutaneous cardiac monitor implantation
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteRussia
- Study dates
- Feb 2008to Nov 2010
- Phase
- Phase 3
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- highly symptomatic patients refractory to at least two antiarrhythmic drugs
- patients with sustained PAF episodes and/or history of PersAF interrupted with cardioversion.
Who cannot join
- congestive heart failure
- ejection fraction <35%
- left atrial diameter >60 mm
- previous ablation procedure
Trial locations and contacts
1 site in 1 country.
Russia1 site
State Research Institute of CIrculation Pathology
Novosibirsk, 630055
About this study
Official title: Typing of the Atrial Fibrillation Recurrences in Early Postoperative Period After Pulmonary Veins Isolation Through Continous Subcutaneous Monitoring.
The aim of this study is to identify the most appropriate method for managing patients with AF recurrences after the first ablation procedure, through the diagnostic data stored by a subcutaneous AF monitor.
- Conditions
- Atrial Fibrillation
- Being tested
- Circumferential PVI and subcutaneous cardiac monitor implantation
- Keywords
- Atrial fibrillation, Percutaneous continous monitoring, 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.
Circumferential PVI and subcutaneous cardiac monitor implantationProcedure or surgery
The left atrium (LA) and PVs were explored through a transeptal approach. Real-time 3D LA maps were reconstructed by using a nonfluoroscopic navigation system (CARTO, Biosense-Webster Inc.). The ipsilateral left and right PVs were encircled in one 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. The endpoint of ablation was PV isolation; this was confirmed when Lasso mapping showed the disappearance of all PV potentials or the dissociation of PV potentials from LA activity.
The ICM (Reveal XT, Medtronic Inc) was implanted the day of the ablation procedure or 1 week before.The Reveal XT was implanted in the parasternal area of the chest. The requirement for defining the exact final position was an R-wave amplitude ≥0.4 mV assessed through the Vector Check.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 (no early recurrence) | Active comparator | Patients without atrial fibrillation recurrences through the implantable cardiac monitors during the 3 months post-ablation period. Receives: Procedure: Circumferential PVI and subcutaneous cardiac monitor implantation |
| Group 2 (early AF recurrence) | Active comparator | Patients with AF recurrences documented by the ICM during the 3 months post-ablation period. Receives: Procedure: Circumferential PVI and subcutaneous cardiac monitor implantation |
| Group 3 (early recurrence-no reablation) | Active comparator | Patients with AF recurrences documented by the ICM during the 3 months post-ablation period from Group 2 would not receive reablation. Receives: Procedure: Circumferential PVI and subcutaneous cardiac monitor implantation |
| Group 4 (early recurrence-early reablation) | Active comparator | Patients with AF recurrences documented by the ICM during the 3 months post-ablation period from Group 2 will receive early reablation based on data stored by implanted monitor. Receives: Procedure: Circumferential PVI and subcutaneous cardiac monitor implantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Freedom from atrial fibrillation or atrial flutter/tachycardia in Group 4 vs Group 3
Measured: 12 months
Secondary outcomes (1)
Freedom from AF in each group and the comparison of any group to each other
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2010 (estimated)
- Study startFeb 2008
- Primary completionFeb 2010
- Study completionNov 2010
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Meshalkin Research Institute of Pathology of Circulation
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Evgeny A Pokushalov, MD, PhD, Principal investigator, State Research Institute of Circulation Pathology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01164319
- Sponsor's protocol ID
- AFERAWCLP-022
- Other IDs
- RU AF 002
- Status last verified
- Apr 2012
- First submitted
- 15 Jul 2010
- Last updated
- 24 Apr 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Pokushalov E, Romanov A, Corbucci G, Artyomenko S, Turov A, Shirokova N, Karaskov A. Use of an implantable monitor to detect arrhythmia recurrences and select patients for early repeat catheter ablation for atrial fibrillation: a pilot study. Circ Arrhythm Electrophysiol. 2011 Dec;4(6):823-31. doi: 10.1161/CIRCEP.111.964809. Epub 2011 Sep 19.
PubMed 21930653
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Typing of the Atrial Fibrillation Recurrences in Early Postoperative Period After Pulmonary Veins Isolation Through Continous Subcutaneous Monitoring.
- ClinicalTrials.gov ID
- NCT01164319
- Acronym / sponsor ID
- AFERAWCLP-022
- Conditions
- Atrial Fibrillation
- Keywords
- Atrial fibrillation, Percutaneous continous monitoring, ablation
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Meshalkin Research Institute of Pathology of CirculationResearch network
- Study start
- Feb 2008
- Primary completion
- Feb 2010 (actual)
- Study completion
- Nov 2010 (actual)
- First posted
- 16 Jul 2010 (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 identify the most appropriate method for managing patients with AF recurrences after the first ablation procedure, through the diagnostic data stored by a subcutaneous AF monitor.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group 1 (no early recurrence) | Active comparator | Procedure: Circumferential PVI and subcutaneous cardiac monitor implantationPatients without atrial fibrillation recurrences through the implantable cardiac monitors during the 3 months post-ablation period. |
| Group 2 (early AF recurrence) | Active comparator | Procedure: Circumferential PVI and subcutaneous cardiac monitor implantationPatients with AF recurrences documented by the ICM during the 3 months post-ablation period. |
| Group 3 (early recurrence-no reablation) | Active comparator | Procedure: Circumferential PVI and subcutaneous cardiac monitor implantationPatients with AF recurrences documented by the ICM during the 3 months post-ablation period from Group 2 would not receive reablation. |
| Group 4 (early recurrence-early reablation) | Active comparator | Procedure: Circumferential PVI and subcutaneous cardiac monitor implantationPatients with AF recurrences documented by the ICM during the 3 months post-ablation period from Group 2 will receive early reablation based on data stored by implanted monitor. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- highly symptomatic patients refractory to at least two antiarrhythmic drugs
- patients with sustained PAF episodes and/or history of PersAF interrupted with cardioversion.
Key exclusion criteria (4 listed)
- congestive heart failure
- ejection fraction <35%
- left atrial diameter >60 mm
- previous ablation procedure
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 |
|---|---|---|
| Circumferential PVI and subcutaneous cardiac monitor implantationThe left atrium (LA) and PVs were explored through a transeptal approach. Real-time 3D LA maps were reconstructed by using a nonfluoroscopic navigation system (CARTO, Biosense-Webster Inc.). The ipsilateral left and right PVs were encircled in one 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. The endpoint of ablation was PV isolation; this was confirmed when Lasso mapping showed the disappearance of all PV potentials or the dissociation of PV potentials from LA activity. The ICM (Reveal XT, Medtronic Inc) was implanted the day of the ablation procedure or 1 week before.The Reveal XT was implanted in the parasternal area of the chest. The requirement for defining the exact final position was an R-wave amplitude ≥0.4 mV assessed through the Vector Check. | Procedure or surgery | Group 1 (no early recurrence), Group 2 (early AF recurrence), Group 3 (early recurrence-no reablation), Group 4 (early recurrence-early reablation) |
Primary outcome
Freedom from atrial fibrillation or atrial flutter/tachycardia in Group 4 vs Group 3
Time frame: 12 months
1 secondary outcome
Freedom from AF in each group and the comparison of any group to each other
Time frame: 12 months
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 24 Apr 2012.
- Results publication: PubMed 21930653Pokushalov E, Romanov A, Corbucci G, Artyomenko S, Turov A, Shirokova N, Karaskov A. Use of an implantable monitor to detect arrhythmia recurrences and select patients for early repeat catheter ablation for atrial fibrillation: a pilot study. Circ Arrhythm Electrophysiol. 2011 Dec;4(6):823-31. doi: 10.1161/CIRCEP.111.964809. Epub 2011 Sep 19.
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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.
Evgeny A 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 3 study testing Circumferential PVI and subcutaneous cardiac monitor implantation 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 2 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: finished, as of the sponsor's last update on 24 Apr 2012. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Freedom from atrial fibrillation or atrial flutter/tachycardia in Group 4 vs Group 3 (time frame: 12 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 NCT01164319, 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 24 Apr 2012.