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

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.

ClinicalTrials.gov IDNCT05841615

PhaseNA

Enrollment120

SponsorThe First Affiliated Hospital of Xiamen University

Age18 Years

SexALL

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Conditions studied

AF - Atrial Fibrillation, HTN-Hypertension

About this study

Interventions

Other: Renal Denervation operation — RDN: 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
Other: Pulmonary vein isolation — PVI: 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.

Primary outcomes

Malignant end point event 1 (within 2 years post operation)
Malignant end point event 2 (within 2 years post operation)
Malignant end point event 3 (within 2 years post operation)
Malignant end point event 4 (within 2 years post operation)

Eligibility information

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 locations

the first affiliated hopital of Xiamen University, Xiamen, Fujian 361003 China

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.