Catheter Ablation Versus Standard Conventional Treatment in Patients With Left Ventricular Dysfunction and Atrial Fibrillation
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Biotronik SE & Co. KG
- Enrollment
- 398
- Locations
- 32
- Primary Endpoint
- All-cause mortality or worsening heart failure requiring unplanned hospitalization
Study Overview
Brief Summary
Atrial fibrillation (AF) is the most common arrhythmia encountered in clinical practice. The incidence and prevalence of AF increase exponentially with increasing age and AF is associated with higher mortality, more frequent hospitalization, and lower quality of life. Furthermore, AF is often associated with heart failure. The majority of AF is initiated by ectopic foci found primarily in the pulmonary veins. It was shown that catheter ablation of those veins could eliminate episodes of AF. In patients with heart failure, catheter ablation could improve cardiac function, symptoms and quality of life. It remains still unknown whether AF ablation is more effective than conventional treatment in terms of mortality and morbidity.
Detailed Description
Atrial fibrillation (AF) is the most common arrhythmia encountered in clinical practice; its incidence and prevalence increase exponentially with increasing age and it is associated with increased mortality, more frequent hospitalization, and decreased quality of life.
An initial approach to the cure of patients suffering from AF was surgical intervention with the Maze procedure, which involved the creation of linear lesions in the atria to break the re-entrant wavefronts responsible for maintenance of AF. Subsequently, less invasive procedures have been developed to achieve the same results. One of them is catheter based radio frequency ablation, in which a catheter is placed in the heart percutaneously, followed by application of electrical energy to the target regions, thereby creating a permanent lesion.
The origin of AF is often localized in the pulmonary veins (PVs); therefore one common approach is to ablate them in order to electrically isolate them from the left atrium (LA). Several strategies have been developed, such as linear, segmental, circumferential, and double-lasso.
Additionally, other anatomical regions such as the right atrium (RA), superior vena cava (SVC), and coronary sinus (CS) can be ablated in order to eliminate non-PV drivers of AF.
Heart failure (HF) is frequently a chronic and lethal condition, causing substantial morbidity and, after initial diagnosis, results in mortality rates which come close to or exceed those of many malignancies.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Symptomatic paroxysmal or persistent atrial fibrillation
- •Failure or intolerance of antiarrhythmic drug therapy or unwillingness to take antiarrhythmic drugs
- •Left Ventricular Ejection Fraction <= 35%
- •NYHA >= II
- •ICD for primary or secondary prevention with atrial sensing capabilities or Cardiac Resynchronization Therapy plus Defibrillator (CRT-D) device, both with Home Monitoring® technology already implanted
- •Patient is willing and able to comply with the protocol and has written informed consent
- •Age >= 18 years
Exclusion Criteria
- •Contraindication for chronic anticoagulation therapy and heparin
- •Documented left atrial diameter > 6 cm
- •Previous left heart ablation procedure for atrial fibrillation
- •Acute coronary syndrome, cardiac surgery, angioplasty or stroke within 2 months prior to enrollment
- •Untreated hypothyroidism or hyperthyroidism
- •Enrollment in another investigational drug or device study
- •Woman currently pregnant or breastfeeding or not using reliable contraceptive measures during fertility age
- •Mental or physical inability to take part in the study
- •Listed for heart transplant
- •Cardiac assist device implanted
- •Planned cardiovascular intervention
- •Life expectancy ≤ 12 months
- •Uncontrolled hypertension
- •Requirement for dialysis due to terminal renal failure
- •Participation in another telemonitoring concept
Arms & Interventions
1
Radiofrequency ablation of atrial fibrillation:
Subjects assigned to the catheter AF ablation strategy will undergo ablation within 48 hours after baseline evaluation. The aim of the procedure is to achieve isolation of all Pulmonary Veins (PVs) and to restore sinus rhythm. Only radiofrequency catheter based AF ablation is permitted; other methods, like cryoablation, ultrasound and laser, are not permitted in this study.
Before ablation, a transesophageal echocardiogram must be performed in order to rule out presence of atrial thrombi.
Anticoagulation should be initiated, or continued, for at least six months post ablation. Six months after successful ablation and in absence of any recurrence of AF, antiarrhythmic drugs should be discontinued.
Intervention: Radiofrequency ablation (Procedure)
2
Conventional treatment:
Subjects assigned to the conventional treatment strategy will be treated according to current guidelines for the management of patients with chronic heart failure and/or atrial fibrillation. Efforts to maintain sinus rhythm in this study arm are recommended.
Anticoagulation will be initiated, if not already started, and maintained throughout the study according to current guidelines.
Intervention: Conventional treatment (Other)
Outcomes
Primary Outcomes
All-cause mortality or worsening heart failure requiring unplanned hospitalization
Time Frame: 7 years
Secondary Outcomes
- All-cause mortality Cardiovascular mortality Unplanned hospitalization due to cardiovascular reason Worsening heart failure requiring unplanned hospitalization Cerebrovascular accidents Left ventricular function Exercise tolerance Quality of life(7 years)