NCT01865591

Brief Summary

The aim of this study is to assess the potential therapeutic benefit of catheter-based renal sympathetic denervation using therapeutic unfocussed ultrasound in a single-arm feasibility trial.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P50-P75 for early_phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2012

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

May 23, 2013

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 31, 2013

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2013

Completed
Last Updated

May 31, 2013

Status Verified

May 1, 2013

Enrollment Period

1.2 years

First QC Date

May 23, 2013

Last Update Submit

May 30, 2013

Conditions

Uncontrolled Hypertension

Keywords

hypertensionuncontrolled hypertensionresistant hypertension

Outcome Measures

Primary Outcomes (1)

  • Major adverse events

    All cause death, renal artery occlusion, renal artery stenosis, renal infarction and/or renal failure

    30 days

Secondary Outcomes (5)

  • Change from baseline in office blood pressure measurement

    30 days, 3 months, 6 months, 9 months, 12 months

  • Change from baseline in ambulatory 24-hour blood pressure measurement

    6 months, 12 months

  • Change from baseline in renal artery dimensions

    30 days

  • Change from baseline in creatinine

    6 months

  • Adverse events and device complications

    12 months

Study Arms (1)

Renal denervation

EXPERIMENTAL

Subjects are treated with unfocussed ultrasound-based renal denervation and are maintained on baseline anti-hypertensive medications.

Device: Ultrasound-based Renal Denervation

Interventions

Ultrasound-based Renal DenervationDEVICE
Also known as: Sound TX System
Renal denervation

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Uncontrolled hypertension (defined as SBP ≥ 140 mmHg during 24Hr Ambulatory BP monitoring)
  • Current treatment with ≥ 3 anti-hypertensive drugs (including at least one diuretic)
  • Renal artery diameter ≥5mm by digital angiography
  • Accessibility of renal vasculature

You may not qualify if:

  • Estimated GFR \< 45
  • Type 1 Diabetes
  • Known renovascular abnormalities (eg, renal artery stenosis, previous renal artery stenting or angioplasty)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Na Homolce Hospital

Prague, Czechia

RECRUITING

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Central Study Contacts

David A. Smith

CONTACT

dsmith@sounditv.com

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 23, 2013

First Posted

May 31, 2013

Study Start

April 1, 2012

Primary Completion

July 1, 2013

Last Updated

May 31, 2013

Record last verified: 2013-05

Locations

CZ(1)