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Clinical Trials in China / NCT05841615
Recruiting Not applicable

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

NCT05841615 · tracked via the Priya Life Science China tracker
Sponsor
The First Affiliated Hospital of Xiamen University
Phase
Not applicable
Started
2023-09-01
Last updated
2024-03-13

Condition(s) studied

AF - Atrial FibrillationHTN-Hypertension

Investigational drug(s) / intervention(s)

Renal Denervation operationPulmonary vein isolation

Renal Denervation operation: RDN: Percutaneous renal artery sympathetic radiofrequency ablation for both sides. For each side, a total of 13 targets were ablated. The ablation power was 8W\~12W for 40 seconds

Pulmonary vein isolation: PVI: Pulmonary vein isolation was performed until the potential of each pulmonary vein disappeared under the guidance of the CARTO mapping system. Ablation of the top line and the bottom line of the left atrium was performed at the same time.

Study 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

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
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

Primary outcome measure(s)

  • Malignant end point event 1 — within 2 years post operation
    Fatal and nonfatal stroke
  • Malignant end point event 2 — within 2 years post operation
    cerebral hemorrhage
  • Malignant end point event 3 — within 2 years post operation
    acute myocardial infarction
  • Malignant end point event 4 — within 2 years post operation
    cardiovascular death

Trial sites (1)

FacilityCityRegionStatus
the first affiliated hopital of Xiamen University Xiamen Fujian Recruiting

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Other trials for the same condition

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05841615 on ClinicalTrials.gov ↗ ← All trials in China