NCT05841615

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)

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: The First Affiliated Hospital of Xiamen University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• AF - Atrial Fibrillation
• HTN-Hypertension

Interventions

Type	Name	Description
OTHER	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
OTHER	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.

Timeline

• Start date: 2023-09-01
• Primary completion: 2026-04-30
• Completion: 2028-04-30
• First posted: 2023-05-03
• Last updated: 2024-03-13

Locations

1 site across 1 country: China