Pulmonary Vein Isolation (PVI) Combined With Renal Denervation (RDN) in Atrial Fibrillation (AF) and Hypertension (HTN)
Recruiting · NCT05841615 · Interventional (participants receive a specific treatment) · Lead sponsor: The First Affiliated Hospital of Xiamen University
View the official record on ClinicalTrials.gov →Interventions studied
Pulmonary vein isolationRenal Denervation operation
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.
Who can take part
Age range
18 Years to 75 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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
Where it is running
2 locations listed.
- the first affiliated hopital of Xiamen University - Xiamen, Fujian, China
- the first affiliated hopital of Xiamen University - Xiamen, Fujian, China