Atrial Fibrillation Reduction by Renal Sympathetic Denervatio
Completed
- Conditions
- atrial fibrillation10007521
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 20
Inclusion Criteria
1. Age >=18 years;
2. Symptomatic paroxysmal or persistent AF;
3. Systolic blood pressure of 140 mmHg or more despite the use of >=2 antihypertensive drugs;
4. A glomerular filtration rate of 45ml/min/1.73m2 or more;
5. Written informed consent;
6. The patient agrees to the follow-up including the implantation of the ICM.
Exclusion Criteria
1. Pregnancy;
2. Renal artery abnormalities;
3. First episode of AF;
4. Long-term persistent or permanent AF
5. The patient has other medical illness (i.e., cancer or congestive heart failure) that may cause the patient to be non-compliant with the protocol, confound the data interpretation or is associated with limited life expectancy (i.e., less than one year);
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>To assess whether renal sympathetic denervation will decrease AF burden in<br /><br>patients with symptomatic paroxysmal or persistent AF at 6 months post<br /><br>procedure. </p><br>
- Secondary Outcome Measures
Name Time Method <p>Primary safety endpoint<br /><br>The occurrence of cardiovascular death, stroke, major access site bleeding,<br /><br>acute kidney injury or renal artery stenosis at 6 months.<br /><br><br /><br>Secondary endpoints<br /><br>• To evaluate the change in office based and 24h ambulatory blood pressure at<br /><br>3, 6 and 12 months post procedure.<br /><br>• To assess quality of live using the Atrial Fibrillation Effect on<br /><br>QualiTy-of-life (AFEQT) Questionnaire pre- and 3, 6 and 12 months post<br /><br>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 volumes and dimensions<br /><br>• Change in left ventricular diastolic function<br /><br>• The occurrence of stroke</p><br>