Pulmonary vein isolation or atrioventricular node ablation in patients with heart failure and symptomatic atrial fibrillation diminishing CRT response (PULVERISE-AF-CRT): A randomized study

Conditions: Atrial fibrillation
heartfailure
10007521

Registration Number: NL-OMON52003

Lead Sponsor: niversitair Medisch Centrum Groningen

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: 100

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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary end point is defined as the hierarchical occurrence of all-cause<br /><br>death, cardiovascular hospitalization (heart failure or stroke), and the change<br /><br>in quality of life at 1 year.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Death from any cause, unplanned hospitalization related to heart failure, death<br /><br>from cardiovascular disease, cerebrovascular accident, unplanned<br /><br>hospitalization for cardiovascular disease, and any hospitalization.<br /><br>Furthermore changes in the Kansas city cardiomyopathy questionnaire were<br /><br>assessed. Also procedure related adverse events and atrial fibrillation-free<br /><br>intervals were assessed. </p><br>