Atrial FibrillationNCT02474108
Surgical Prevention of Atrial Fibrillation in Patients With Rheumatic Mitral Valve Lesion and Left Atrium Enlargement
A study testing surgical prevention of atrial fibrillation and cardiomonitor in people with Atrial Fibrillation and Rheumatic Heart Disease, run by Meshalkin Research Institute of Pathology of Circulation at 1 site in Russia.
Trial summary
This study evaluates the safety and efficiency of surgical prevention of atrial fibrillation in patients with valvular heart disease and left atrium enlargement Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Atrial Fibrillation, Rheumatic Heart Disease
- What is being tested?
- surgical prevention of atrial fibrillation and cardiomonitor
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteRussia
- Study dates
- 2 Mar 2015to 20 Oct 2016
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- rheumatic mitral valve lesion
- the absence a history of AF
- sinus rhythm
- left atrium size more than 6.0 cm
Who cannot join
- refusal to participate in the study
- aortic stenosis / regurgitation
- coronary atherosclerosis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pilot, Randomized,Single Blind Trial of Surgical Prevention of Atrial Fibrillation in Patients With Rheumatic Mitral Valve Lesion
This study evaluates the safety and efficiency of surgical prevention of atrial fibrillation in patients with valvular heart disease and left atrium enlargement
Read the detailed description
Preservation or appearance of AF(atrial fibrillation) after mitral valve surgery substantially reduce the number of excellent and good results of the operation in the long-term period, causing circulatory insufficiency, increased pulmonary hypertension, increasing the risk of thromboembolic events and stroke.
Significant predictors of AF after surgery are the initial size of the left atrium more than 6.0 cm, stenotic lesions and rheumatic genesis of mitral defect. 80% of patients in this group had AF during the first year after operation.
- Conditions
- Atrial Fibrillation, Rheumatic Heart Disease
- Being tested
- surgical prevention of atrial fibrillation, cardiomonitor
- Keywords
- atrial fibrillation, radiofrequency ablation, prevention of AF, mitral valve, left atrium enlargement, cryoablation
- Medical subject headings
- Atrial Fibrillation, Rheumatic Heart Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
surgical prevention of atrial fibrillationProcedure or surgery
Prophylactic surgical ablation is performed to prevent AF in patients during mitral valve surgery. Ablation is performed by radiofrequency electrode or cryoprobe. Pulmonary veins, posterior wall of the left atrium will be isolated by the scheme box-lesion with additional lines to the mitral valve and appendage of left atrium.
cardiomonitorDevice
in both groups cardiac rhythm will be controlled by a cardiomonitor
| Study group | Role | What they receive |
|---|---|---|
| without prevention | Placebo comparator | isolated mitral valve replacement or reconstruction, implantation of cardiac monitor Receives: Device: cardiomonitor |
| group of prevention | Active comparator | mitral valve replacement or reconstruction with surgical prevention of AF (concomitant ablation of the left atrium) and implantation of cardiac monitor.
Prophylactic surgical ablation is performed to prevent AF in patients during mitral valve surgery. Ablation is performed by radiofrequency electrode or cryoprobe. Receives: Procedure: surgical prevention of atrial fibrillation; Device: cardiomonitor |
What is being measured
The primary outcome is the main question the study is designed to answer.
composite outcome measure of complications
Measured: up to 1 year
Secondary outcomes (2)
number of participants with freedom from AF according to the long-term ECG monitoring
Measured: 1 year
transport function of the left atrium according to TTE (transthoracic echo)
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 posted17 Jun 2015 (estimated)
- Study start2 Mar 2015
- Primary completion5 May 2016
- Study completion20 Oct 2016
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
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (actual)
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
- NCT02474108
- Sponsor's protocol ID
- SPAF
- Status last verified
- Sep 2017
- First submitted
- 23 Apr 2015
- Last updated
- 11 Sep 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot, Randomized,Single Blind Trial of Surgical Prevention of Atrial Fibrillation in Patients With Rheumatic Mitral Valve Lesion
- ClinicalTrials.gov ID
- NCT02474108
- Acronym / sponsor ID
- SPAF
- Conditions
- Atrial Fibrillation, Rheumatic Heart Disease
- Keywords
- atrial fibrillation, radiofrequency ablation, prevention of AF, mitral valve, left atrium enlargement, cryoablation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Meshalkin Research Institute of Pathology of CirculationResearch network
- Study start
- 2 Mar 2015 (actual)
- Primary completion
- 5 May 2016 (actual)
- Study completion
- 20 Oct 2016 (actual)
- First posted
- 17 Jun 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.
This study evaluates the safety and efficiency of surgical prevention of atrial fibrillation in patients with valvular heart disease and left atrium enlargement
Detailed description
Preservation or appearance of AF(atrial fibrillation) after mitral valve surgery substantially reduce the number of excellent and good results of the operation in the long-term period, causing circulatory insufficiency, increased pulmonary hypertension, increasing the risk of thromboembolic events and stroke.
Significant predictors of AF after surgery are the initial size of the left atrium more than 6.0 cm, stenotic lesions and rheumatic genesis of mitral defect. 80% of patients in this group had AF during the first year after operation.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| without prevention | Placebo comparator | Device: cardiomonitorisolated mitral valve replacement or reconstruction, implantation of cardiac monitor |
| group of prevention | Active comparator | Procedure: surgical prevention of atrial fibrillation, Device: cardiomonitormitral valve replacement or reconstruction with surgical prevention of AF (concomitant ablation of the left atrium) and implantation of cardiac monitor. Prophylactic surgical ablation is performed to prevent AF in patients during mitral valve surgery. Ablation is performed by radiofrequency electrode or cryoprobe. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- rheumatic mitral valve lesion
- the absence a history of AF
- sinus rhythm
- left atrium size more than 6.0 cm
Key exclusion criteria (3 listed)
- refusal to participate in the study
- aortic stenosis / regurgitation
- coronary atherosclerosis
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 prevention of atrial fibrillationProphylactic surgical ablation is performed to prevent AF in patients during mitral valve surgery. Ablation is performed by radiofrequency electrode or cryoprobe. Pulmonary veins, posterior wall of the left atrium will be isolated by the scheme box-lesion with additional lines to the mitral valve and appendage of left atrium. | Procedure or surgery | group of prevention |
| cardiomonitorin both groups cardiac rhythm will be controlled by a cardiomonitor | Device | group of prevention, without prevention |
Primary outcome
composite outcome measure of complications
Time frame: up to 1 year
2 secondary outcomes
number of participants with freedom from AF according to the long-term ECG monitoring
Time frame: 1 year
transport function of the left atrium according to TTE (transthoracic echo)
Time frame: 1 year
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 11 Sep 2017.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing surgical prevention of atrial fibrillation and cardiomonitor in people with Atrial Fibrillation and Rheumatic Heart Disease, 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 4 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: finished, as of the sponsor's last update on 11 Sep 2017. 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. Some participants in this study may receive a placebo. 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 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?
composite outcome measure of complications (time frame: up to 1 year). 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 11 Sep 2017.