Trials / Completed
CompletedNCT01756300
RENABLATE Feasibility Study CS156 (EC12-02) Study of Catheter Based Renal Denervation to Treat Resistant Hypertension
A Prospective, Multi-Center, Non-Randomized Feasibility Study of Catheter-Based Renal Denervation to Treat Resistant Hypertension (RENABLATE- EC12-02)
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 35 (actual)
- Sponsor
- Biosense Webster, Inc. · Industry
- Sex
- All
- Age
- 19 Years – 84 Years
- Healthy volunteers
- Not accepted
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.
Detailed 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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Celsius® ThermoCool® RD | The investigational device is designed to transmit radiofrequency (RF) current to the electrodes for ablation purposes, specifically for the treatment of resistant hypertension by renal denervation. |
Timeline
- Start date
- 2012-12-01
- Primary completion
- 2013-11-01
- Completion
- 2015-04-01
- First posted
- 2012-12-25
- Last updated
- 2025-02-04
- Results posted
- 2015-08-25
Source: ClinicalTrials.gov record NCT01756300. Inclusion in this directory is not an endorsement.