Pulmonary Vein Isolation (PVI) Combined With Renal Denervation (RDN) in Atrial Fibrillation (AF) and Hypertension (HTN)

Recruitment & Eligibility

Inclusion Criteria

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.

Exclusion Criteria

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
identified secondary hypertension or Pseudo hypertension except for renal parenchymal hypertension;
malignant tumors or end-stage diseases;
Severe peripheral vascular disease, abdominal aortic aneurysm
whose left atrium is larger than 55mm
obvious bleeding tendency and blood system diseases;
Severe peripheral vascular disease, abdominal aortic aneurysm;
A history of the acute coronary syndrome within two weeks;
acute or severe systemic infection;
drug or alcohol dependence or refusal to sign informed consent.
Other conditions that are not suitable for PVI and RDN

Study & Design

Arm && Interventions

Group	Intervention	Description
PVI and RDN	Pulmonary vein isolation	Participants experience both PVI and RDN operations
PVI alone	Pulmonary vein isolation	Participants only experience PVI operations
PVI and RDN	Renal Denervation operation	Participants experience both PVI and RDN operations

Primary Outcome Measures

Name	Time	Method
Malignant end point event 1	within 2 years post operation	Fatal and nonfatal stroke
Malignant end point event 2	within 2 years post operation	cerebral hemorrhage
Malignant end point event 4	within 2 years post operation	cardiovascular death
Malignant end point event 3	within 2 years post operation	acute myocardial infarction

Secondary Outcome Measures

Name	Time	Method
Complex end point event 2	within 2 years post operation	elevation of blood pressure(mmHg, upper arm blood pressure electronic monitor)
Complex end point event 1	within 2 years post operation	Hospitalization for heart failure
Complex end point event 3	within 2 years post operation	left ventricular hypertrophy(mm, by Cardiac color ultrasound)
Complex end point event 5	within 2 years post operation	transient ischemic attack
Complex end point event 4	within 2 years post operation	coronary revascularization(by coronary arteriography)
Complex end point event 10	within 2 years post operation	the control rate of blood pressure
Complex end point event 7	within 2 years post operation	renal artery stenosis(by renal arteriography)
Complex end point event 6	within 2 years post operation	renal insufficiency (eGFR ml/min, by ECT);
Complex end point event 8	within 2 years post operation	proteinuria(mg/L, PRM assay)
Complex end point event 9	within 2 years post operation	the recurrence rate of atrial fibrillation

Recruitment & Eligibility