Completed

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

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What is being collected

Procedure Data

Collected from today forward - Prospective
Procedure
Who is being recruted

Over 18 Years
+9 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Cohort

Tracking disease incidence in order to identify risk factors and understand disease progression over time.
Observational
Study Start: June 2013
See protocol details

Summary

Principal SponsorCardiovascular Center Frankfurt
Last updated: July 28, 2016
Sourced from a government-validated database.Claim as a partner

Study start date: June 1, 2013

Actual date on which the first participant was enrolled.

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.

NCT01834118
Principal SponsorCardiovascular Center Frankfurt
Last updated: July 28, 2016
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

10 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Cohort

These studies follow a group of individuals with common characteristics (such as a condition or birth year) over a specific period to study health outcomes or exposures.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Criteria

5 inclusion criteria required to participate
Individual is >= 18 years old
Individual is willing to provide written informed consent to participate in this study
Individual received renal denervation >= 12 months prior to study participation to no therapeutical avail and is scheduled for reintervention
Individual receives 3 or more antihypertensive drugs including one diuretic
Show More Criteria
4 exclusion criteria prevent from participating
Individual has any serious medical condition which in the opinion of the investigator may adversely affect the participation
Individual has hypertension secondary to an identifiable and treatable cause
Individual is pregnant, nursing or planning to be pregnant
Renal artery abnormalities which may affect the procedure

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Study Objectives

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

CardioVascular Center Frankfurt

Frankfurt am Main, GermanyOpen CardioVascular Center Frankfurt in Google Maps
CompletedOne Study Center