Atrial FibrillationNCT02303652
Biatrial Contractility Recovery After Maze
An observational study of Atrial Fibrillation, run by Centro Cardiologico Monzino.
Trial summary
This study aimed at evaluating multiple aspects of biatrial contractility recovery after modified maze procedure during mitral valve surgery. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- Radiofrequency maze procedure and Transthoracic echocardiography
- Type of treatment
- Surgery or procedure
- How many people
- 122 participants
- Where
- No sites listed yet
- Study dates
- Jan 2005to Nov 2014
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients affected by atrial fibrillation undergoing mitral valve surgery
Who may be able to join
- Patients affected by atrial fibrillation undergoing mitral valve surgery
Who cannot join
- Other cardiac procedures in addition to mitral valve surgery
About this study
Official title: Surgical Treatment of Concomitant Atrial Fibrillation: a Comprehensive Insight Into Biatrial Contractility Recovery.
This study aimed at evaluating multiple aspects of biatrial contractility recovery after modified maze procedure during mitral valve surgery.
Read the detailed description
Atrial fibrillation (AF) is a frequent complication in patients affected by mitral valve disease, causing systemic embolism, cardiac chamber dilation and decreased cardiac output. Cox et al. have designed the maze procedure as a surgical treatment for patients with AF in whom conventional therapy has failed and their lesion set is nowadays currently performed with different energy sources in order to surgically treat such supraventricular arrhythmia. In particular, the original maze was designed with three specific goals in mind: 1) the permanent AF ablation 2) the restoration of atrioventricular synchrony and 3) the preservation of atrial transport function (1). If , by one side, the efficacy of the procedure in reaching the first two goals are widely known, the restoration of the sinus rhythm does not always accompany the corresponding recovery of atrial mechanical "kick". If the atrial transport function fails to recover, benefits deriving from arrhythmia abolition might only be marginal, since, by one side, blood stasis in the atria persist, thus maintaining unchanged thromboembolic risk and, by the other side, heart hemodynamic performance is still impaired resulting from the loss of atrial contribution to cardiac output. Despite its relevant role for judging maze comprehensive success, atrial contractility outcome and clinical importance have not been deeply investigated. The purposes of this study were to evaluate by serial transthoracic echocardiography temporal modality of biatrial contractility restoration, predictive factors of atrial transport recovery and its possible relationship with cardiac chambers dimensions and function evolution after radiofrequency (RF) maze during mitral surgery.
- Conditions
- Atrial Fibrillation
- Being tested
- Radiofrequency maze procedure, Transthoracic echocardiography
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radiofrequency maze procedureProcedure or surgery
RF energy was used to create continous endocardial and epicardial lesions mimicking most of the left atrial incisions set as described in the Cox Maze III procedure. In all patients a bipolar device was used (Cardioblate BP2 Irrigated RF Surgical Ablation System®, Medtronic Inc, Minneapolis, MN, USA).
Transthoracic echocardiographyProcedure or surgery
Contemporary to clinical follow up, all patients were evaluated with 2-dimensional transthoracic echocardiography (Philips ultrasound system (iE33®, Andover, MA, USA)) at 3,6,12,24 months in order to specifically monitor the evolution of cardiac chambers dimensions and systolic performance and to record left and right atrial contractility presence.
What is being measured
The primary outcome is the main question the study is designed to answer.
Biatrial contractility recovery after maze
All patients were evaluated with 2-dimensional transthoracic echocardiography at 3,6,12,24 months in order to specifically monitor the evolution of cardiac chambers dimensions and systolic performance and to record left and right atrial contractility presence.
Transmitral flow velocity was measured with pulsed Doppler echocardiography, with a sample volume positioned at the level of the mitral tip in the apical four-chamber view and was recorded on a strip chart at a paper speed of 100 mm/s. Peak velocity and the time-velocity integral of the early filling wave (E wave) and of the late filling wave (A wave) were determined. A/E ratio, representing atrial contribution to ventricular diastolic filling, was obtained. Each measurement was obtained as an average of 6 to 8 consecutive beats.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2014 (estimated)
- Study startJan 2005
- Primary completionNov 2014
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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 122 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centro Cardiologico Monzino
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Claudia Loardi, Centro Cardiologico Monzino
- Investigators
- Claudia Loardi, MD, Principal investigator, Centro Cardiologico Monzino Milano - Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02303652
- Sponsor's protocol ID
- ACFA1
- Status last verified
- Nov 2014
- First submitted
- 24 Nov 2014
- Last updated
- 1 Dec 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Surgical Treatment of Concomitant Atrial Fibrillation: a Comprehensive Insight Into Biatrial Contractility Recovery.
- ClinicalTrials.gov ID
- NCT02303652
- Acronym / sponsor ID
- ACFA1
- Conditions
- Atrial Fibrillation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 122 participants (actual)
- Lead sponsor
- Centro Cardiologico MonzinoUniversity, hospital or other
- Study start
- Jan 2005
- Primary completion
- Nov 2014 (actual)
- First posted
- 1 Dec 2014 (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 aimed at evaluating multiple aspects of biatrial contractility recovery after modified maze procedure during mitral valve surgery.
Detailed description
Atrial fibrillation (AF) is a frequent complication in patients affected by mitral valve disease, causing systemic embolism, cardiac chamber dilation and decreased cardiac output. Cox et al. have designed the maze procedure as a surgical treatment for patients with AF in whom conventional therapy has failed and their lesion set is nowadays currently performed with different energy sources in order to surgically treat such supraventricular arrhythmia. In particular, the original maze was designed with three specific goals in mind: 1) the permanent AF ablation 2) the restoration of atrioventricular synchrony and 3) the preservation of atrial transport function (1). If , by one side, the efficacy of the procedure in reaching the first two goals are widely known, the restoration of the sinus rhythm does not always accompany the corresponding recovery of atrial mechanical "kick". If the atrial transport function fails to recover, benefits deriving from arrhythmia abolition might only be marginal, since, by one side, blood stasis in the atria persist, thus maintaining unchanged thromboembolic risk and, by the other side, heart hemodynamic performance is still impaired resulting from the loss of atrial contribution to cardiac output. Despite its relevant role for judging maze comprehensive success, atrial contractility outcome and clinical importance have not been deeply investigated. The purposes of this study were to evaluate by serial transthoracic echocardiography temporal modality of biatrial contractility restoration, predictive factors of atrial transport recovery and its possible relationship with cardiac chambers dimensions and function evolution after radiofrequency (RF) maze during mitral surgery.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients affected by atrial fibrillation undergoing mitral valve surgery
Key inclusion criteria (1 listed)
- Patients affected by atrial fibrillation undergoing mitral valve surgery
Key exclusion criteria (1 listed)
- Other cardiac procedures in addition to mitral valve surgery
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 |
|---|---|---|
| Radiofrequency maze procedureRF energy was used to create continous endocardial and epicardial lesions mimicking most of the left atrial incisions set as described in the Cox Maze III procedure. In all patients a bipolar device was used (Cardioblate BP2 Irrigated RF Surgical Ablation System®, Medtronic Inc, Minneapolis, MN, USA). | Procedure or surgery | – |
| Transthoracic echocardiographyContemporary to clinical follow up, all patients were evaluated with 2-dimensional transthoracic echocardiography (Philips ultrasound system (iE33®, Andover, MA, USA)) at 3,6,12,24 months in order to specifically monitor the evolution of cardiac chambers dimensions and systolic performance and to record left and right atrial contractility presence. | Procedure or surgery | – |
Primary outcome
Biatrial contractility recovery after maze
Time frame: 24 months
All patients were evaluated with 2-dimensional transthoracic echocardiography at 3,6,12,24 months in order to specifically monitor the evolution of cardiac chambers dimensions and systolic performance and to record left and right atrial contractility presence. Transmitral flow velocity was measured with pulsed Doppler echocardiography, with a sample volume positioned at the level of the mitral tip in the apical four-chamber view and was recorded on a strip chart at a paper speed of 100 mm/s. Peak velocity and the time-velocity integral of the early filling wave (E wave) and of the late filling wave (A wave) were determined. A/E ratio, representing atrial contribution to ventricular diastolic filling, was obtained. Each measurement was obtained as an average of 6 to 8 consecutive beats.
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 1 Dec 2014.
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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.
Claudia Loardi, MD principal investigator
Centro Cardiologico Monzino Milano - Italy
Questions about this trial
What is this clinical trial studying?
An observational study of Atrial Fibrillation, run by Centro Cardiologico Monzino.
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 1 inclusion and 1 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 1 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
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 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?
Biatrial contractility recovery after maze (time frame: 24 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 1 Dec 2014.