A randomized controlled trial of AV junction ablation and biventricular pacing versus optimal pharmacological therapy in patients with permanent atrial fibrillatio

Withdrawn

• Conditions: Atrial fibrillation; heart failure; 10019280

• Registration Number: NL-OMON48055
• Lead Sponsor: 'Nuccia e Vittore Corbella' Centrum preventie hart-en longziekten te Rapallo (Genua)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Withdrawn
• Sex: Not specified
• Target Recruitment: 30

Inclusion Criteria

a) Permanent AF (> 6 months) which has been considered unsuitable for AF
ablation or which resulted in failed AF ablation;
b) Severely symptomatic (AF-related symptoms), refractory to drug therapy
for rate control;
c) QRS duration * 110 ms;
d) At least one hospitalization related to AF and/or heart failure in the
previous year (see definition in section IV. Statistical Methods and Data
Analysis in protocol);

Exclusion Criteria

a) Patient is less than 18 years of age;
b) NYHA class IV and systolic blood pressure * 80 mmHg despite optimal
therapy;
c) Myocardial infarction within the previous 3 months;
d) Previously implanted cardiac devices (pacemaker/ICD/CRT) with *5%
pacing function. Patients who had devices implanted that had <5% of paced beats
(i.e., back*up
pacing) can be enrolled;
e) Severe concomitant non-cardiac disease;
f) Need for surgical intervention. (Cardiac surgery is scheduled)
g) Patients with LVEF >50% are excluded

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Total mortality at 48 months</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>At 48 months a combined endpoint of cardiovascular mortality and<br /><br>hospitalization for heart failure or uncontrolled intolerable AF</p><br>