Primary objective: to study in patients with heart failure and AF whether PVI or atrioventricular node ablation is non inferior with regard to all-cause mortality, cardiovascular hospitalization or changes in quality of life. Secondary objective: to…
ID
Source
Brief title
Condition
- Cardiac arrhythmias
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary end point is defined as the hierarchical occurrence of all-cause
death, cardiovascular hospitalization (heart failure or stroke), and the change
in quality of life at 1 year.
Secondary outcome
Death from any cause, unplanned hospitalization related to heart failure, death
from cardiovascular disease, cerebrovascular accident, unplanned
hospitalization for cardiovascular disease, and any hospitalization.
Furthermore changes in the Kansas city cardiomyopathy questionnaire were
assessed. Also procedure related adverse events and atrial fibrillation-free
intervals were assessed.
Background summary
Pulmonary vein isolation (PVI) is currently the cornerstone non pharmacological
therapy for drug-refractory atrial fibrillation (AF). Where rhythm control has
been shown to be inferior as compared to rate control in older trials. New data
suggest that for patients with heart failure and AF PVI may improve prognosis
(mortality) as compared to medical rate or rhythm control. Whether optimal rate
control as can be achieved with atrioventricular node ablation is comparable
with regard to all-cause mortality of heart failure hospitalization to PVI in
patients with heart failure and AF is unknown.
Study objective
Primary objective: to study in patients with heart failure and AF whether PVI
or atrioventricular node ablation is non inferior with regard to all-cause
mortality, cardiovascular hospitalization or changes in quality of life.
Secondary objective: to study cardiovascular morbidity related to PVI or
atrioventricular node ablation.
Study design
Study design: Single centre, randomized study.
Intervention
all patients will undergo either PVI or atrioventricular node ablation.
Study burden and risks
Most investigations during the study are standard clinical care. PVI is shown
to be effective to increase left ventricular ejection fraction in patients with
heart failure. Also AV node ablation might be beneficial and is recommended by
current guidelines to achieve adequate rate control. However, there have been
no trials to randomize patient to either of these treatment strategies with
relation to major cardiovascular outcomes
Hanzeplein 1
Groningen 9700RB
NL
Hanzeplein 1
Groningen 9700RB
NL
Listed location countries
Age
Inclusion criteria
• Presence of a cardiac resynchronization therapy device (CRT-D or CRT-P) and
optimal medical therapy according to current guidelines.
• Patients with paroxysmal or persistent AF, having AF or HF related symptoms.
• Patient with paroxysmal AF should have >25% burden or inadequate
biventricular pacing (<95%) based on device counters.
• The patient is willing and able to comply with the protocol and has provided
written informed consent.
• Age >= 18 years
Exclusion criteria
• Documented left atrial diameter > 6 cm (parasternal long axis).
• Longstanding persistent AF longer than 2 years.
• Contraindication to chronic anticoagulation therapy or heparin
• Previous left heart ablation procedure for AF
• Acute coronary syndrome, cardiac surgery, angioplasty or stroke within 2
months prior to enrolment
• Untreated hypothyroidism or hyperthyroidism
• Enrolment 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 participate 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
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL76855.042.21 |