About this trial
The close relationship between the increase of sympathetic tension, AF, and HTN cannot be ignored. In addition, the significant failure rate of PVI (20-50%) in the treatment of AF makes it very necessary to explore the effect of RDN on AF. Therefore, this study aims to compare the effects and safety of PVI alone and PVI combined with RDN with AF combined with HTN, which will open a new chapter for PVI combined with RDN in the treatment of AF.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
18<age<75years
clinic blood pressure≥140/90mmHg or 24-hour ambulatory blood pressure monitoring average blood pressure ≥135/85mmHg
Ecg diagnosis of atrial fibrillation ;
who signed informed consent and were approved by the Ethics Committee of the First Affiliated Hospital of Xiamen University.
Disqualifiers
pregnant women or lactating patients;
Patients who were unsuitable for ablation before surgery (unilateral or bilateral renal artery shape and structure were found: renal artery stenosis exceeding 50%, renal aneurysm, previous renal artery interventional surgery, renal artery malformation, renal artery diameter < 4mm or length of treatable segment < 20mm)
Patients who only have one kidney or have a history of kidney transplantation
Patients with a history of renal arterial intervention or renal denervation
Trial design
Parallel
Treatments tested in this trial
Renal Denervation operation
Other interventionRDN: Percutaneous renal artery sympathetic radiofrequency ablation for both sides. For each side, a total of 13 targets were ablated. The ablation power was 8W\~12W for 40 seconds
Pulmonary vein isolation
Other interventionPVI: Pulmonary vein isolation was performed until the potential of each pulmonary vein disappeared under the guidance of the CARTO mapping system. Ablation of the top line and the bottom line of the left atrium was performed at the same time.
Treatment groups
Trial outcomes
Primary outcomes
Malignant end point event 1
Fatal and nonfatal stroke
Malignant end point event 2
cerebral hemorrhage
Malignant end point event 3
acute myocardial infarction
Malignant end point event 4
cardiovascular death
Secondary outcomes
Complex end point event 1
Hospitalization for heart failure
Complex end point event 2
elevation of blood pressure(mmHg, upper arm blood pressure electronic monitor)
Complex end point event 3
left ventricular hypertrophy(mm, by Cardiac color ultrasound)
Complex end point event 4
coronary revascularization(by coronary arteriography)
Sponsors and contacts
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