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RENABLATE Feasibility Study CS156 (EC12-02) Study of Catheter Based Renal Denervation to Treat Resistant Hypertension

Hypertension, Renal Clinical Trial

Official title:
A Prospective, Multi‐Center, Non‐Randomized Feasibility Study of Catheter‐Based Renal Denervation to Treat Resistant Hypertension (RENABLATE- EC12-02)

Clinical Trial Summary

The RENABLATE feasibility study is a prospective, multi-center, non-randomized feasibility study to evaluate the safety and effectiveness of the investigational multi-electrode ablation catheter and integrated ablation system to treat resistant hypertension.

Clinical Trial Description

The RENABLATE feasibility study CS156 (EC12-02) is a prospective, multi-center, non-randomized feasibility study to evaluate the safety and effectiveness of renal artery sympathetic denervation using the investigational Celsius® ThermoCool® Renal Denervation (RD) Multi-electrode Ablation Catheter and integrated ablation system to treat resistant hypertension. ;

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01756300
Study type Interventional
Source Biosense Webster, Inc.
Contact
Status Completed
Phase Phase 1
Start date December 2012
Completion date April 2015
View Details
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