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NCT01834118 Clinical Trial

Reintervention-study After Previous Renal Denervation in Non-responding Patients With Severe Hypertension

Hypertension, Resistant to Conventional Therapy Clinical Trial

— RETREAT  

Official title:
Reintervention After Previous Renal Denervation in Non-responding Patients With Severe Hypertension

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01834118
Other study ID # CVC-001
Secondary ID
Status Completed
Phase N/A
First received April 15, 2013
Last updated July 27, 2016
Start date June 2013
Est. completion date April 2016

Study information
Verified date July 2016
Source Cardiovascular Center Frankfurt
Contact n/a
Is FDA regulated No
Health authority Germany: Ethics Commission
Study type Observational [Patient Registry]

Clinical Trial Summary

The purpose of this study is to determine the effect of repeated renal denervation in non-responding patients with severe hypertension. Therefore ultrasound technique will be used.

Description:

Renal Denervation is a CE-certified opportunity for treating patients with therapy-refractory hypertension. In some patients it doesn't show a significant lowering of the blood pressure, so a repeated renal denervation is an option.

In this study repeated renal denervation will be performed with the Recor Paradise Ultrasound Catheter.

For the study no specific procedures are required which would exceed the standard renal denervation procedure with the CE-certified Recor Paradise Ultrasound Catheter System.

There are no additional risks for the patient in consequence of participating in the study or the follow up procedures.

Recruitment information / eligibility
Status Completed
Enrollment 10
Est. completion date April 2016
Est. primary completion date April 2016
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Individual is =18 years old

- Individual received renal denervation =12 months prior to study participation to no therapeutical avail and is scheduled for reintervention.

- Systolic Office based blood pressure =140mmHg

- Individual receives 3 or more antihypertensive drugs including one diuretic

- Individual is willing to provide written informed consent to participate in this study

Exclusion Criteria:

- Individual has hypertension secondary to an identifiable and treatable cause

- Individual has any serious medical condition which in the opinion of the investigator may adversely affect the participation.

- Individual is pregnant, nursing or planning to be pregnant

- Renal artery abnormalities which may affect the procedure

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Intervention

Procedure:
• Renal Denervation
Sympathetic nerve ablation via transcatheter renal denervation

Locations
Country Name City State
Germany CardioVascular Center Frankfurt Frankfurt Hessen

Sponsors (1)
Lead Sponsor Collaborator
Cardiovascular Center Frankfurt

Country where clinical trial is conducted

Germany, 

Outcome
Type Measure Description Time frame Safety issue
Primary Office Blood pressure measurement up to1 year No
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