- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01019759
The Value of add-on Arrhythmia Surgery in Patients With Atrial Fibrillation Undergoing Cardiac Surgery
The Value of add-on Arrhythmia Surgery in Patients With Paroxysmal or Persistent Atrial Fibrillation Undergoing Valvular or Coronary Bypass Surgery. A Randomised Comparison on Quality of Life, Cost-effectiveness, Morbidity and Rhythm Outcome.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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 we do not know whether add-on arrhythmia surgery indeed affects morbidity and quality of life. In this respect the benefit of chronic sinus rhythm has to outweigh the risks of a prolonged operation. In addition, cardiovascular complaints unrelated to AF may persist even after successful operation, thus offsetting the benefit of chronic sinus rhythm. Add-on surgery is more costly than standard surgery but this may compare favourably with shorter hospital admission due to less frequent post-operative AF.
Valvular heart disease is frequently associated with ventricular remodelling: a decreased ventricular function and atrial dilatation. AF itself may worsen heart failure due to a tachycardiomyopathy. Elimination of AF might therefore enhance recovery from structural and functional remodelling and promote recovery of quality of life after the operation.
The PIAF, RACE and AFFIRM have shown that chronic sinus rhythm is not necessarily associated with a reduced morbidity or enhanced quality of life. PIAF however showed that exercise tolerance was better when rhythm control was achieved. Further analyses of RACE and AFFIRM are pending. One drawback of the above studies is the fact that chronic sinus rhythm is difficult to obtain. In PIAF, RACE and AFFIRM only 30 to 50% was in sinus rhythm at the end of follow-up. By contrast, arrhythmia surgery is a highly effective treatment in this respect.
Forty patients underwent a (phase 1-study) coronary bypass- or valve surgery with add-on arrhythmia surgery in the same way as in this protocol proposed. This means epicardial on beating heart and without use of the heart-lung machine. In the last follow-up 80 % of the patients not longer were in atrial fibrillation. With similar treatment procedures, but more invasive, so on the arrested heart and endo cardially, success percentages reported varying from 60 % till 80%.
This large variance in success rate is probably related to the primary course of the disease and the degree of the morphological abnormality. In spite of these meaningful results ''add-on'' arrhythmia surgery is no general accepted treatment. The intended patient population remains generally untreated. Historical data of patients from the university hospital of Maastricht show that no add on treatment has a success rate of 25% of patients in sinus rhythm.
Considering the above a randomised comparison of add-on arrhythmia surgery and standard surgery is warranted.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Limburg
-
Maastricht, Limburg, Netherlands, 6202 AZ
- Maastricht University Medical Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Patients undergo valvular surgery, coronary surgery, or a combination of both.
- All patients have documented chronic atrial fibrillation of paroxysmal atrial fibrillation.
- Patients have given written informed consent.
Exclusion Criteria:
- Patients who do not speak Dutch or can not read Dutch.
- Patients with a Sick Sinus Syndrome.
- Patients with contraindications for oral anticoagulant agents.
- Patients unable to express their specific wishes.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: No add-on AF-surgery
patient undergoing only scheduled valve and/or coronary bypass surgery
|
|
Experimental: PV isolation
patient undergoing add-on epicardial microwave energy pulmonary vein isolation
|
The off-pump beating heart ablation procedure is performed.
Using a Microwave (MW) energy ablation tool (Microwave generator by Guidant), epicardial ablation line isolating the pulmonary veins are applied during open heart surgery
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Percentage of patients free from atrial fibrillation, as apparent from 24 hour Holter registration, in addition to standard ECG. For the purpose of this primary endpoint, AF was defined as lasting longer than 10 seconds.
Time Frame: between 3 months and 12 months post-operative
|
between 3 months and 12 months post-operative
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Quality of life (QoL)
Time Frame: at 3, 6 and12 months post-operative
|
at 3, 6 and12 months post-operative
|
Cost-effectiveness
Time Frame: intraoperative untill 12 months post-operative
|
intraoperative untill 12 months post-operative
|
In-hospital morbidity (incl. pulmonary complications, resternotomy for surgical bleeding, cerebrovascular accidents, acute myocardial infarction, renal failure, development of atrioventricular conduction abnormalities)
Time Frame: post-operative, in-hospital period
|
post-operative, in-hospital period
|
Rhythm related events and interventions (incl. electrical or chemical cardioversion, percutaneous catheter ablation, implantation of a defibrillator, pacemaker implantation)
Time Frame: discharge untill 12 months post-operative
|
discharge untill 12 months post-operative
|
Out-of-hospital morbidity (incl. acute myocardial infarction, percutaneous catheter ablation, implantation of a defibrillator, pacemaker implantation and cerebrovascular accidents, syncope)
Time Frame: discharge untill 12 months post-operative
|
discharge untill 12 months post-operative
|
Mortality
Time Frame: intraoperative untill 12 months post-operative
|
intraoperative untill 12 months post-operative
|
Collaborators and Investigators
Investigators
- Principal Investigator: Jos G Maessen,, MD, PhD, dept. Cardiothoracic Surgery, University hospital of Maastricht
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MEC 02-119.3
- PF 178
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Atrial Fibrillation
-
Ablacon, Inc.CompletedArrhythmias, Cardiac | Atrial Fibrillation, Persistent | Persistent Atrial Fibrillation | Longstanding Persistent Atrial FibrillationGermany
-
Ablacon, Inc.RecruitingAtrial Fibrillation | Arrhythmias, Cardiac | Arrhythmia | Atrial Flutter | Atrial Fibrillation, Persistent | Atrial Tachycardia | Atrial Arrhythmia | Atrial Fibrillation Paroxysmal | Atrial Fibrillation, Paroxysmal or PersistentUnited States, Belgium, Netherlands, Czechia
-
AtriCure, Inc.Active, not recruitingPersistent Atrial Fibrillation | Atrial Fibrillation (AF) | Longstanding Persistent Atrial FibrillationUnited States
-
Barts & The London NHS TrustAtriCure, Inc.Not yet recruitingAtrial Fibrillation, Persistent | Persistent Atrial Fibrillation | Atrial Arrhythmia | Atrium; FibrillationUnited Kingdom
-
Maastricht University Medical CenterRWTH Aachen UniversityUnknownAtrial Fibrillation (Paroxysmal) | Atrial Fibrillation Recurrent | Atrial Fibrillation Common Gene VariantsNetherlands
-
Adagio MedicalRecruitingAtrial Fibrillation | Atrial Flutter | Paroxysmal Atrial Fibrillation | Persistent Atrial FibrillationNetherlands, Germany, Belgium
-
Vivek ReddyEnrolling by invitationAtrial Fibrillation and Flutter | Atrial Flutter Typical | Atrial Fibrillation, Paroxysmal or PersistentUnited States
-
St. George's Hospital, LondonRecruitingAtrial Fibrillation | Atrial Fibrillation, Persistent | Persistent Atrial Fibrillation | Atrial ArrhythmiaUnited Kingdom
-
R-PharmFSBI "National Medical Research Center of Cardiology named after academician...CompletedAtrial Flutter | Paroxysmal Atrial Fibrillation | Persistent Atrial FibrillationRussian Federation
-
Fundació Institut de Recerca de l'Hospital de la...RecruitingAtrial Arrhythmia | Atrial Fibrillation and Flutter | Atrial Fibrillation RecurrentSpain
Clinical Trials on pulmonary vein isolation
-
University of LeipzigRecruiting
-
University Medical Center GroningenBoston Scientific CorporationNot yet recruiting
-
Instituto de investigación e innovación biomédica...Active, not recruitingAtrial Fibrillation, PersistentSpain
-
Hospital General Universitario de AlicanteNot yet recruiting
-
AtriCure, Inc.Active, not recruitingAtrial FibrillationUnited States
-
Asklepios proresearchCompletedAtrial Fibrillation | TachycardiaGermany
-
Haukeland University HospitalUniversity Hospital of North Norway; St. Olavs HospitalCompletedPersistent Atrial FibrillationNorway
-
Diagram B.V.CompletedParoxysmal Atrial Fibrillation | Persistent Atrial Fibrillation | Out of Range Hypertension | Signs of Sympathetic OverdriveSpain, Netherlands
-
Hospital Clinic of BarcelonaRecruiting
-
Robert Bosch Medical CenterRecruitingAtrial Fibrillation Paroxysmal | Catheter AblationGermany