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Heart rhythm procedure with or without kidney nerve treatment for atrial fibrillation and hypertension

Compares a heart rhythm procedure alone or with kidney nerve treatment in atrial fibrillation patients.

Plain-language title generated from the registry record
Registry title: Pulmonary Vein Isolation (PVI) Combined With Renal Denervation (RDN) in Atrial Fibrillation (AF) and Hypertension (HTN)

Key facts

Where
Xiamen, ChinaSee the site

AI summary: who the study is looking for

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with atrial fibrillation and high blood pressure. It compares pulmonary vein isolation alone with pulmonary vein isolation plus renal denervation.

Age
Over 18 and under 75 years
Sex
All sexes
Disease stage
Atrial fibrillation shown on an ECG, plus high blood pressure: clinic blood pressure ≥140/90mmHg or 24-hour average blood pressure ≥135/85mmHg.
Earlier treatment
No earlier kidney artery procedure or renal denervation.

Main reasons for not taking part

  • Pregnant or breastfeeding women
  • Only one kidney or a past kidney transplant
  • Kidney artery problems, such as narrowing over 50%, an aneurysm or a diameter under 4mm
  • Left atrium larger than 55mm
  • Secondary hypertension (except from kidney tissue disease), cancer or end-stage disease

Read by machine on 9 November 2026.

Could this be for you?

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 18 and 75 years old?

Source: NCT05841615, who can take part

Where in China

  • the first affiliated hopital of Xiamen UniversityXiamen, ChinaTaking people

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?
Print a page for my doctor

Trial details

Who runs it
The First Affiliated Hospital of Xiamen University
Trial code
NCT05841615
Record updated
13 March 2024
Original description
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.Read full original descriptionShow less

Evaluation of the Safety and Efficacy of Pulmonary Vein Isolation (PVI) Combined With Renal Denervation (RDN) in Patients With 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.

Inclusion: 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: 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); drug or alcohol dependence or refusal to sign informed consent; 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; 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; Other conditions that are not suitable for PVI and RDN; pregnant women or lactating patients; whose left atrium is larger than 55mm.

ClinicalTrials.gov NCT05841615