Pulmonary Vein Isolation (PVI) Combined With Renal Denervation (RDN) in Atrial Fibrillation (AF) … (NCT05841615) | Clinical Trial Compass
RecruitingNot Applicable
Pulmonary Vein Isolation (PVI) Combined With Renal Denervation (RDN) in Atrial Fibrillation (AF) and Hypertension (HTN)
China120 participantsStarted 2023-09-01
Plain-language summary
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 participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Malignant end point event 1
Timeframe: within 2 years post operation
2
Malignant end point event 2
Timeframe: within 2 years post operation
3
Malignant end point event 3
Timeframe: within 2 years post operation
4
Malignant end point event 4
Timeframe: within 2 years post operation
Trial details
NCT IDNCT05841615
SponsorThe First Affiliated Hospital of Xiamen University