Actively Recruiting

Phase Not Applicable
Age: 18Years - 75Years
All Genders
NCT05841615

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

Led by The First Affiliated Hospital of Xiamen University · Updated on 2024-03-13

120

Participants Needed

1

Research Sites

243 weeks

Total Duration

On this page

AI-Summary

What this Trial Is 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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age between 18 and 75 years
  • Clinic blood pressure of 140/90 mmHg or higher, or 24-hour average blood pressure of 135/85 mmHg or higher
  • Diagnosis of atrial fibrillation by ECG
  • Signed informed consent and approval by the Ethics Committee of the First Affiliated Hospital of Xiamen University
Not Eligible

You will not qualify if you...

  • Pregnant or breastfeeding women
  • Unsuitable for ablation due to renal artery conditions such as stenosis over 50%, aneurysm, prior renal artery surgery, malformation, artery diameter less than 4 mm, or treatable segment length less than 20 mm
  • Having only one kidney or a history of kidney transplantation
  • Previous renal arterial intervention or renal denervation
  • Secondary or pseudo hypertension except renal parenchymal hypertension
  • Malignant tumors or end-stage diseases
  • Severe peripheral vascular disease or abdominal aortic aneurysm
  • Left atrium larger than 55 mm
  • Bleeding tendency or blood system diseases
  • Acute coronary syndrome within the last two weeks
  • Acute or severe systemic infection
  • Drug or alcohol dependence
  • Refusal to sign informed consent
  • Other conditions unsuitable for PVI and RDN

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

the first affiliated hopital of Xiamen University

Xiamen, Fujian, China, 361003

Actively Recruiting

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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