Treatment of atrial fibrillation in patients with high sympathetic activity by pulmonary vein isolation in combination with renal denervation or pulmonary vein isolation only; an international randomized, controlled trial.
Completed
- Conditions
- Atrial fibrillationhypertensionHypertensie en signalen van sympathische overactiviteit10007521
- Registration Number
- NL-OMON47122
- Lead Sponsor
- Isala Klinieken
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 100
Inclusion Criteria
The patient falls within the target group resistent hypertension or sympathic overdrive
Patient is an acceptable candidate for renal denervation treatment
Patient is < 75 year of age
Exclusion Criteria
Contraindication to chronic anticoagulation therapy or heparin
Previous left heart ablation procedure for AF
Acute coronary syndrome, cardiac surgery, PCI or stroke within 3 months prior to enrolment
Renal artery stenosis >50% of the arterial lumen, or renal artery lumen <=3 mm
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Time to first detection of atrial fibrillation >30 seconds, with the monitoring<br /><br>period starting 3 months after the intervention.</p><br>
- Secondary Outcome Measures
Name Time Method <p>- AF burden after 12 months of follow-up, expressed in % of the monitoring<br /><br>period, in patients with continuous rhythm monitoring. The monitoring period<br /><br>starts 3 months after the intervention.<br /><br>- Blood pressure at 3, 6, 12 months after the intervention, and change in blood<br /><br>pressure compared to measurement before the intervention<br /><br>- Blood pressure and heart rate response changes induced by exercise testing<br /><br>- Changes in heart rate variability measures tested by Holter monitoring<br /><br>compared to measurement before the intervention<br /><br>- Changes in arterial stiffness measures post intervention AASI (ambulatory<br /><br>arterial stiffness index) by ambulatory blood pressure monitoring, PWV (pulse<br /><br>wave velocity) and augmentation index compared to measurement before the<br /><br>intervention</p><br>