Atrial Fibrillation improvement by renal denervatio

Recruiting

• Conditions: - paroxysmal of persistent atrial fibrillation - hypertension

• Registration Number: NL-OMON26212
• Lead Sponsor: Erasmus Medical Center, Rotterdam, the Netherlands

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 28 February 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 20

Inclusion Criteria

1. Age ¡Ý18 years;

2. Symptomatic paroxysmal or persistent AF;

Exclusion Criteria

1. Pregnancy;

2. Renal artery abnormalities;

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary efficacy endpoint<br /><br>To assess whether renal sympathetic denervation will decrease AF burden<br>(min/day) in patients with symptomatic paroxysmal or persistent AF at 6 months post procedure.<br><br /><br /><br>Primary safety endpoint<br /><br>The occurrence of cardiovascular death, stroke, major access site bleeding, acute<br>kidney injury or renal artery stenosis at 6 months.

Secondary Outcome Measures

Name	Time	Method
• To evaluate the change in office based and 24h ambulatory blood pressure<br>at baseline vs. 3, 6 and 12, 24 and 36 months post procedure.<br /><br>• To assess quality of live using the Atrial Fibrillation Effect on QualiTy-of-life<br>(AFEQT) Questionnaire pre- and 3, 6 and 12 months post procedure.<br /><br>• Newly acquired renal artery stenosis and/or repeat renal artery intervention.<br /><br>• Need for electrical cardioversion<br /><br>• Change in left ventricular and atrial volumes and dimensions at baseline vs.<br>3, 6, 12, 24 and 36 months post-procedure.<br>• Change in left ventricular diastolic function at baseline vs. 3, 6, 12, 24 and<br>36 months post-procedure.<br /><br>• The occurrence of stroke at baseline vs. 3, 6, 12, 24 and 36 months postprocedure.