Combining Pulmonary Vein Isolation with Renal Denervation for Atrial Fibrillation and Hypertension
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)
This study is testing if combining two treatments, Pulmonary Vein Isolation and Renal Denervation, can help people with Atrial Fibrillation and high blood pressure feel better and have better results than using just one treatment alone.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | The First Affiliated Hospital of Xiamen University Academic / other |
| Locations | 1 site (Xiamen, Fujian) |
| Trial ID | NCT05841615 on ClinicalTrials.gov |
What this trial studies
This study investigates the effects and safety of combining Pulmonary Vein Isolation (PVI) with Renal Denervation (RDN) in patients suffering from Atrial Fibrillation (AF) and Hypertension (HTN). Given the high failure rate of PVI alone, the research aims to determine if the addition of RDN can improve outcomes for these patients. Participants will be monitored for their blood pressure and ECG results to assess the effectiveness of the combined treatment approach. The study is designed to provide insights into a potentially new treatment paradigm for managing AF in the context of hypertension.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 75 with diagnosed Atrial Fibrillation and hypertension that meets specific blood pressure criteria.
Not a fit: Patients with certain renal conditions, previous renal interventions, or secondary hypertension may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved treatment outcomes for patients with Atrial Fibrillation and Hypertension.
How similar studies have performed: While the combination of PVI and RDN is a novel approach, previous studies have shown promise in treating AF with various interventions, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Xiamen, Fujian
- the first affiliated hopital of Xiamen University — Xiamen, Fujian, China (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.