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Observational Study of the EnligHTN Renal Denervation System in Europe

NCT02006758 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 68

Last updated 2019-10-16

Study results available
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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.

Conditions

Interventions

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).

Sponsors & Collaborators

  • Abbott Medical Devices

    lead INDUSTRY

Principal Investigators

  • José Diaz, MD · Hospital Juan Ramon Jimenez, Huelva, Spain

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-11-30
Primary Completion
2017-05-31
Completion
2017-05-31

Countries

  • Belgium
  • Estonia
  • Italy
  • Portugal
  • Spain
  • United Kingdom

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02006758 on ClinicalTrials.gov