The Value of add-on Arrhythmia Surgery in Patients With Atrial Fibrillation Undergoing Cardiac Surgery

This study has been completed.
Sponsor:
Information provided by:
Maastricht University Medical Center
ClinicalTrials.gov Identifier:
NCT01019759
First received: July 6, 2009
Last updated: November 23, 2009
Last verified: November 2009
  Purpose

The hypothesis being studied is that add-on arrhythmia surgery in patients with atrial fibrillation (AF) undergoing valvular or coronary surgery improves quality of life, is cost-effective, reduces perioperative and long-term morbidity associated with AF.


Condition Intervention
Atrial Fibrillation
Procedure: pulmonary vein isolation

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: 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.

Resource links provided by NLM:


Further study details as provided by Maastricht University Medical Center:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Quality of life (QoL) [ Time Frame: at 3, 6 and12 months post-operative ] [ Designated as safety issue: No ]
  • Cost-effectiveness [ Time Frame: intraoperative untill 12 months post-operative ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • Mortality [ Time Frame: intraoperative untill 12 months post-operative ] [ Designated as safety issue: Yes ]

Enrollment: 150
Study Start Date: September 2002
Study Completion Date: December 2006
Primary Completion Date: November 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Procedure: 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:
  • Microwave generator by Guidant
  • Flex 4 or Flex 10 ablation probes by Guidant

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients undergo valvular surgery, coronary surgery, or a combination of both.
  2. All patients have documented chronic atrial fibrillation of paroxysmal atrial fibrillation.
  3. Patients have given written informed consent.

Exclusion Criteria:

  1. Patients who do not speak Dutch or can not read Dutch.
  2. Patients with a Sick Sinus Syndrome.
  3. Patients with contraindications for oral anticoagulant agents.
  4. Patients unable to express their specific wishes.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01019759

Locations
Netherlands
Maastricht University Medical Center
Maastricht, Limburg, Netherlands, 6202 AZ
Sponsors and Collaborators
Maastricht University Medical Center
Investigators
Principal Investigator: Jos G Maessen,, MD, PhD dept. Cardiothoracic Surgery, University hospital of Maastricht
  More Information

No publications provided

Responsible Party: Prof Dr. JG Maessen, dept Cardiothoracic Surgery, Maastricht University Medical Center
ClinicalTrials.gov Identifier: NCT01019759     History of Changes
Other Study ID Numbers: MEC 02-119.3, PF 178
Study First Received: July 6, 2009
Last Updated: November 23, 2009
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Maastricht University Medical Center:
Atrial fibrillation
cardiac surgery
ablation
pulmonary veins

Additional relevant MeSH terms:
Arrhythmias, Cardiac
Atrial Fibrillation
Heart Diseases
Cardiovascular Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on August 25, 2014