NCT05841615 Pulmonary Vein Isolation (PVI) Combined With Renal Denervation (RDN) in Atrial Fibrillation (AF) and Hypertension (HTN)
| NCT ID | NCT05841615 |
| Status | Recruiting |
| Phase | — |
| Sponsor | The First Affiliated Hospital of Xiamen University |
| Condition | AF - Atrial Fibrillation |
| Study Type | INTERVENTIONAL |
| Enrollment | 120 participants |
| Start Date | 2023-09-01 |
| Primary Completion | 2026-04-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 120 participants in total. It began in 2023-09-01 with a primary completion date of 2026-04-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
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
Frequently Asked Questions
Who can join the NCT05841615 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying AF - Atrial Fibrillation. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05841615 currently recruiting?
Yes, NCT05841615 is actively recruiting participants. Visit ClinicalTrials.gov or contact The First Affiliated Hospital of Xiamen University to inquire about joining.
Where is the NCT05841615 trial being conducted?
This trial is being conducted at Xiamen, China.
Who is sponsoring the NCT05841615 clinical trial?
NCT05841615 is sponsored by The First Affiliated Hospital of Xiamen University. The trial plans to enroll 120 participants.
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