Atrial FibrillationNCT00886080
The Effect of Arrhythmia Surgery on Quality of Life in Patients With Atrial Fibrillation Undergoing Cardiac Surgery
A study testing Pulmonary vein isolation using microwave energy in people with Atrial Fibrillation, run by Maastricht University Medical Center at 1 site in Netherlands.
Trial summary
Atrial fibrillation (AF) is connected with an increased morbidity and mortality. In addition, quality of life is diminished due to palpitations, dyspnea, dizziness and syncope. AF is frequently associated with valvular and coronary disease. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- Pulmonary vein isolation using microwave energy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteNetherlands
- Study dates
- Oct 2002to Nov 2005
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients undergo valvular surgery and/ or coronary surgery,
- All patients have documented chronic atrial fibrillation of paroxysmal atrial fibrillation.
- Patients have given written informed consent.
Who cannot join
- Patients who do not speak Dutch or can not read Dutch.
- Patients with a Sick Sinus Syndrome.
- Patients with contraindications for oral anticoagulant agents.
- Incompetent to act for oneself
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Dept. of Cardiothoracic Surgery, University Hospital Maastricht
Maastricht, 6202 AZ
About this study
Official title: A Prospective Randomised Multicentre Comparison on Health Related Quality of Life: the Value of Add-on Arrhythmia Surgery in Patients With Atrial Fibrillation Undergoing Valvular and/or Coronary Bypass Surgery
Atrial fibrillation (AF) is connected with an increased morbidity and mortality. In addition, quality of life is diminished due to palpitations, dyspnea, dizziness and syncope. AF is frequently associated with valvular and coronary disease. In the AF patients undergoing valvular or coronary surgery the arrhythmia almost always relapses. For symptom control anti-arrhythmic drugs and cardioversion are used but breakthrough arrhythmias and side effects of the drugs happen frequently. For more effective symptom control "add-on" arrhythmia surgery is being advocated. However, at present the investigators do not know whether add-on arrhythmia surgery indeed affects morbidity and quality of life.
The hypothesis being studied is that add-on arrhythmia surgery in patients with AF undergoing valvular or coronary surgery improves quality of life, establishes chronic sinus rhythm and reduces perioperative and long-term morbidity associated with AF.
Read the detailed description
Multicentre prospective parallel randomised controlled trial. In total 150 patients with documented atrial fibrillation (chronic and paroxysmal), were randomly assigned by a central computer system to undergo cardiac surgery with add-on surgery or without. This assignment was blinded to patients and all medical personnel except for the surgical team during total follow up. Patients completed quality of life questionnaires, comprising the RAND 36-item Health Survey 1.0 (SF-36), Multidimensional Fatigue Inventory-20 (MFI-20) and EuroQoL (EQ-5D and VAS) at baseline and 3, 6 and 12 months following operation.
- Conditions
- Atrial Fibrillation
- Being tested
- Pulmonary vein isolation using microwave energy
- Keywords
- Atrial fibrillation, Health related Quality of Life, Add-on surgery, Ablation, Randomised controlled trial, SF-36, EuroQoL, MFI-20
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pulmonary vein isolation using microwave energyProcedure or surgery
Also called PV-isolation
The surgical ablation procedure is the first step during surgery and is performed before institution of cardiopulmonary bypass allowing off-pump beating heart ablation. The off-pump beating heart ablation procedure is performed according to a specific box lesion surrounding the pulmonary veins, using microwave energy. Afterwards cardiac surgery is performed as usual in both treatment arms.
| Study group | Role | What they receive |
|---|---|---|
| Add-on arrhythmia surgery | Experimental | Adjuvant anti-arrhythmic surgery consists of a beating heart epicardial "box" isolation of all pulmonary veins using microwave energy (Flex 4 or Flex 10 ablation probes and Microwave generator by Guidant/Afix, Fremont, CA, USA). The surgical ablation procedure is the first step during surgery and is performed before institution of cardiopulmonary bypass allowing off-pump beating heart ablation. In addition excision or exclusion of the left atrial appendage is performed in both the treated as the control group. Receives: Procedure: Pulmonary vein isolation using microwave energy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of life and maintenance of sinus rhythm at 1 year will be considered as primary end points.
Measured: Baseline, 3, 6, and 12 months after operation
Secondary outcomes (1)
In-hospital and out-of-hospital morbidity and mortality during one year follow-up
Measured: Baseline, 1, 6 and 12 months after operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2009 (estimated)
- Study startOct 2002
- Primary completionNov 2005
- Study completionNov 2005
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.
- More trials run by Maastricht University Medical CenterThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Profileringsfonds Maastricht
- Investigators
- Jos G. Maessen, PhD, Study chair, Maastricht University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00886080
- Sponsor's protocol ID
- PF 178
- Other IDs
- PF 178
- Status last verified
- Apr 2009
- First submitted
- 20 Apr 2009
- Last updated
- 22 Apr 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
Van Breugel HN, Nieman FH, Accord RE, Van Mastrigt GA, Nijs JF, Severens JL, Vrakking R, Maessen JG. A prospective randomized multicenter comparison on health-related quality of life: the value of add-on arrhythmia surgery in patients with paroxysmal, permanent or persistent atrial fibrillation undergoing valvular and/or coronary bypass surgery. J Cardiovasc Electrophysiol. 2010 May;21(5):511-20. doi: 10.1111/j.1540-8167.2009.01655.x. Epub 2009 Nov 17.
PubMed 19925605
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomised Multicentre Comparison on Health Related Quality of Life: the Value of Add-on Arrhythmia Surgery in Patients With Atrial Fibrillation Undergoing Valvular and/or Coronary Bypass Surgery
- ClinicalTrials.gov ID
- NCT00886080
- Acronym / sponsor ID
- PF 178
- Conditions
- Atrial Fibrillation
- Keywords
- Atrial fibrillation, Health related Quality of Life, Add-on surgery, Ablation, Randomised controlled trial, SF-36, EuroQoL, MFI-20
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Collaborators
- Profileringsfonds Maastricht
- Study start
- Oct 2002
- Primary completion
- Nov 2005 (actual)
- Study completion
- Nov 2005 (actual)
- First posted
- 22 Apr 2009 (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.
Atrial fibrillation (AF) is connected with an increased morbidity and mortality. In addition, quality of life is diminished due to palpitations, dyspnea, dizziness and syncope. AF is frequently associated with valvular and coronary disease. In the AF patients undergoing valvular or coronary surgery the arrhythmia almost always relapses. For symptom control anti-arrhythmic drugs and cardioversion are used but breakthrough arrhythmias and side effects of the drugs happen frequently. For more effective symptom control "add-on" arrhythmia surgery is being advocated. However, at present the investigators do not know whether add-on arrhythmia surgery indeed affects morbidity and quality of life.
The hypothesis being studied is that add-on arrhythmia surgery in patients with AF undergoing valvular or coronary surgery improves quality of life, establishes chronic sinus rhythm and reduces perioperative and long-term morbidity associated with AF.
Detailed description
Multicentre prospective parallel randomised controlled trial. In total 150 patients with documented atrial fibrillation (chronic and paroxysmal), were randomly assigned by a central computer system to undergo cardiac surgery with add-on surgery or without. This assignment was blinded to patients and all medical personnel except for the surgical team during total follow up. Patients completed quality of life questionnaires, comprising the RAND 36-item Health Survey 1.0 (SF-36), Multidimensional Fatigue Inventory-20 (MFI-20) and EuroQoL (EQ-5D and VAS) at baseline and 3, 6 and 12 months following operation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Add-on arrhythmia surgery | Experimental | Procedure: Pulmonary vein isolation using microwave energyAdjuvant anti-arrhythmic surgery consists of a beating heart epicardial "box" isolation of all pulmonary veins using microwave energy (Flex 4 or Flex 10 ablation probes and Microwave generator by Guidant/Afix, Fremont, CA, USA). The surgical ablation procedure is the first step during surgery and is performed before institution of cardiopulmonary bypass allowing off-pump beating heart ablation. In addition excision or exclusion of the left atrial appendage is performed in both the treated as the control group. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Patients undergo valvular surgery and/ or coronary surgery,
- All patients have documented chronic atrial fibrillation of paroxysmal atrial fibrillation.
- Patients have given written informed consent.
Key exclusion criteria (4 listed)
- Patients who do not speak Dutch or can not read Dutch.
- Patients with a Sick Sinus Syndrome.
- Patients with contraindications for oral anticoagulant agents.
- Incompetent to act for oneself
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 |
|---|---|---|
| Pulmonary vein isolation using microwave energyAlso: PV-isolationThe surgical ablation procedure is the first step during surgery and is performed before institution of cardiopulmonary bypass allowing off-pump beating heart ablation. The off-pump beating heart ablation procedure is performed according to a specific box lesion surrounding the pulmonary veins, using microwave energy. Afterwards cardiac surgery is performed as usual in both treatment arms. | Procedure or surgery | Add-on arrhythmia surgery |
Primary outcome
Quality of life and maintenance of sinus rhythm at 1 year will be considered as primary end points.
Time frame: Baseline, 3, 6, and 12 months after operation
1 secondary outcome
In-hospital and out-of-hospital morbidity and mortality during one year follow-up
Time frame: Baseline, 1, 6 and 12 months after operation
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 22 Apr 2009.
- Derived from this study: PubMed 19925605Van Breugel HN, Nieman FH, Accord RE, Van Mastrigt GA, Nijs JF, Severens JL, Vrakking R, Maessen JG. A prospective randomized multicenter comparison on health-related quality of life: the value of add-on arrhythmia surgery in patients with paroxysmal, permanent or persistent atrial fibrillation undergoing valvular and/or coronary bypass surgery. J Cardiovasc Electrophysiol. 2010 May;21(5):511-20. doi: 10.1111/j.1540-8167.2009.01655.x. Epub 2009 Nov 17.
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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.
Jos G. Maessen, PhD study chair
Maastricht University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pulmonary vein isolation using microwave energy in people with Atrial Fibrillation, run by Maastricht University Medical Center at 1 site in Netherlands.
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 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 22 Apr 2009. 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 Netherlands. 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.
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?
Quality of life and maintenance of sinus rhythm at 1 year will be considered as primary end points. (time frame: Baseline, 3, 6, and 12 months after operation). 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 NCT00886080, 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 22 Apr 2009.