RecruitingNot ApplicableNCT05841615

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)


Sponsor

The First Affiliated Hospital of Xiamen University

Enrollment

120 participants

Start Date

Sep 1, 2023

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study combines two heart procedures in one session for people with both atrial fibrillation (an irregular heartbeat) and high blood pressure: pulmonary vein isolation (a procedure that electrically isolates the areas of the heart causing the irregular rhythm) and renal denervation (a catheter-based procedure that reduces overactive nerve signals driving high blood pressure). **You may be eligible if...** - You are 18 to 75 years old - You have diagnosed atrial fibrillation confirmed on ECG - You have high blood pressure (clinic reading of at least 140/90 mmHg or 24-hour average of at least 135/85 mmHg) **You may NOT be eligible if...** - You are pregnant or breastfeeding - You have significant renal artery problems (stenosis, aneurysm, prior stenting) that make renal denervation unsafe - You have had a recent blood clot, stroke, or heart attack - You have severe kidney disease Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

OTHERRenal 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

OTHERPulmonary 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.


Locations(1)

the first affiliated hopital of Xiamen University

Xiamen, Fujian, China

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT05841615