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RENABLATE Feasibility - EC12-02

2014-08-27 04:00:37 | BioPortfolio

Summary

The RENABLATE study is a prospective, multi-center, non-randomized feasibility study to evaluate the safety and effectiveness of the investigational Celsius® ThermoCool® 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

Conditions

Renal Denervation

Intervention

Renal Sympathetic Denervation, Celsius® ThermoCool® RD Multi-electrode Ablation Catheter

Location

Peninsula Heart Centre
Frankston
Victoria
Australia
3199

Status

Active, not recruiting

Source

Biosense Webster, Inc.

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T04:00:37-0400

Clinical Trials [1975 Associated Clinical Trials listed on BioPortfolio]

Renal Sympathetic Denervation From The Adventitia on Hypertension

Renal sympathetic denervation from the intima of renal arteries has become an important method for the treatment of resistant hypertension, but renal sympathetic nerve are mainly located i...

Multi-electrode Radiofrequency Renal Denervation System Feasibility Study

This is a prospective, single-arm, non-randomized and open label feasibility study. The study is intended to evaluate safety and efficacy of multi-electrode radiofrequency renal denervati...

Systemic Microvascular Function in Patients With Resistant Hypertension After Renal Sympathetic Denervation

It has been proposed that the modulation of the activity of the sympathetic nervous system, through renal sympathetic denervation, besides reducing blood pressure, would promote an improve...

Symap Mapping/ Ablation of Renal Nerve Trial

To evaluate the safety and efficacy of targeted renal sympathetic denervation using SyMapCath I™ in patients with pharmacotherapy and uncontrolled hypertension for at least 6 months, the...

Renal Denervation Therapy in Hypertensive Patients Undergoing A-Fib Ablation

We propose a pilot study to assess safety and benefit of renal artery ablation at the time of planned atrial fibrillation ablation.

PubMed Articles [7997 Associated PubMed Articles listed on BioPortfolio]

Procedural and anatomical predictors of renal denervation efficacy using two radiofrequency renal denervation catheters in a porcine model.

Several renal denervation (RDN) systems are currently under investigation for treatment of hypertension by ablation of renal sympathetic nerves. The procedural efficacy of devices, however, is variabl...

Renal sympathetic nerve activity after catheter-based renal denervation.

Catheter-based renal sympathetic denervation (RDN) has been considered a potential treatment for therapy resistant hypertension (RHT). However, in a randomized placebo-controlled trial, RDN did not le...

Effects of renal sympathetic denervation on myocardial structure, function and perfusion: A serial CMR study.

Echocardiographic studies have shown improvements in cardiac indices associated with renal sympathetic denervation (RDN), however, the benefits on myocardial perfusion have never been assessed. This t...

Intravascular imaging, histopathological analysis, and catecholamine quantification following catheter-based renal denervation in a swine model: the impact of prebifurcation energy delivery.

The purpose of this study was to evaluate the impact of prebifurcation renal denervation in a swine model and assess its safety through optical coherence tomography (OCT). Prebifurcation renal denerva...

Predictors for profound blood pressure response in patients undergoing renal sympathetic denervation.

Renal sympathetic denervation (RDN) as treatment for hypertension shows highly variable results. Although some patients do not show any blood pressure (BP) change and in most patients a BP reduction o...

Medical and Biotech [MESH] Definitions

An electrochemical technique for measuring the current that flows in solution as a function of an applied voltage. The observed polarographic wave, resulting from the electrochemical response, depends on the way voltage is applied (linear sweep or differential pulse) and the type of electrode used. Usually a mercury drop electrode is used.

Removal of tissue by vaporization, abrasion, or destruction. Methods used include heating tissue by hot liquids or microwave thermal heating, freezing (CRYOABLATION), chemical ablation, and photoablation with LASERS.

Ganglia of the sympathetic nervous system including the paravertebral and the prevertebral ganglia. Among these are the sympathetic chain ganglia, the superior, middle, and inferior cervical ganglia, and the aorticorenal, celiac, and stellate ganglia.

Nerve fibers which project from sympathetic ganglia to synapses on target organs. Sympathetic postganglionic fibers use norepinephrine as transmitter, except for those innervating eccrine sweat glands (and possibly some blood vessels) which use acetylcholine. They may also release peptide cotransmitters.

An X-linked inherited metabolic disease caused by a deficiency of lysosomal ALPHA-GALACTOSIDASE A. It is characterized by intralysosomal accumulation of globotriaosylceramide and other GLYCOSPHINGOLIPIDS in blood vessels throughout the body leading to multi-system complications including renal, cardiac, cerebrovascular, and skin disorders.

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