NCT05841615Recruiting
Pulmonary Vein Isolation (PVI) Combined With Renal Denervation (RDN) in Atrial Fibrillation (AF) and Hypertension (HTN)
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)
Source: ClinicalTrials.gov · Last updated 13 Mar 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 120 (estimated)
- First submitted
- 4 Apr 2023
- Start date
- 1 Sept 2023
- Primary completion date
- 30 Apr 2026
- Lead sponsor
- The First Affiliated Hospital of Xiamen University
- Diseases
- Atrial fibrillation, High blood pressure
- NCT number
- NCT05841615
What you commit to
- Study type: Interventional
- Planned participants: 120
- From 1 Sept 2023 to the primary completion date, 30 Apr 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other illness
- 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
Other
- pregnant women or lactating patients;
- whose left atrium is larger than 55mm
Who the study is looking for
- 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.
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| the first affiliated hopital of Xiamen University Coordinator of this site? Confirm its status | Xiamen | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.