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

Xiamen University

Status: Enrolling

Conditions: AF - Atrial Fibrillation; HTN-Hypertension

Treatments: Other: Pulmonary vein isolation; Other: Renal Denervation operation

Study type: Interventional

Funder types: Other

Identifiers

NCT05841615

2022-RDN and PVI

Details and patient eligibility

About

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.

Enrollment: 120 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 2 patient groups

PVI alone

Sham Comparator group

Description:

Participants only experience PVI operations

Treatment:

Other: Pulmonary vein isolation

PVI and RDN

Experimental group

Description:

Participants experience both PVI and RDN operations

Treatment:

Other: Pulmonary vein isolation

Other: Renal Denervation operation