NCT02006758

Observational Study of the EnligHTN Renal Denervation System in Europe

EnligHTN European Observational Study

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 68 (actual)
• Sponsor: Abbott Medical Devices · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this observational study is to further evaluate the safety and performance of the EnligHTN™ Renal Denervation System in the treatment of participants with uncontrolled hypertension in clinical routine practice.

Detailed description

The EnligHTN European Observational study is designed to collect more data, critical to the benefit of the therapy, within a clinical routine setting.

Conditions

• Uncontrolled Hypertension

Interventions

Type	Name	Description
DEVICE	EnligHTN™ Renal Denervation System	The EnligHTN™ Renal Denervation System is designed to deliver radiofrequency (RF) energy to the renal nerves to achieve targeted denervation. The system consists of the EnligHTN™ RF Ablation Generator (generator), the EnligHTN™ Renal Artery Ablation Catheter (ablation catheter), and the EnligHTN™ Guiding Catheter (optional).

Timeline

• Start date: 2013-11-01
• Primary completion: 2017-05-01
• Completion: 2017-05-01
• First posted: 2013-12-10
• Last updated: 2019-10-16
• Results posted: 2019-10-16

Locations

13 sites across 6 countries: Belgium, Estonia, Italy, Portugal, Spain, United Kingdom