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WithdrawnNCT01939392RAPID IIUpdated Aug 18, 2015

Rapid Renal Sympathetic Denervation for Resistant Hypertension II

A Phase 2/3 interventional study of Renal Denervation (OneShot™ Renal Denervation System) in Resistant Hypertension, Uncontrolled Hypertension and Renal Artery Ablation, sponsored by Medtronic Endovascular. Withdrawn at 1 site in Italy. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2015-08-18.

Sponsored by Medtronic Endovascular · Phase 2/3, Interventional, and Treatment

Phase
Phase 2/3
Study type
Interventional
Enrollment
0
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study summary

This is a global, multi-center, prospective, randomized, controlled study of the safety and effectiveness of renal denervation with the OneShot Renal Denervation System in patients with uncontrolled hypertension.

02

Conditions studied

  • Resistant Hypertension
  • Uncontrolled Hypertension
  • Renal Artery Ablation

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Keywords

  • Resistant hypertension
  • Uncontrolled hypertension
  • Renal artery ablation
03

In context

Hypertension

6,689 studies on the registry are indexed under Hypertension; 965 are open to participants now.

Browse Hypertension studies →

Lead sponsor

Medtronic Endovascular is the lead sponsor of 50 studies on the registry; 3 are open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 4 (80%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Individual has a systolic blood pressure ≥ 160 mmHg based on an average of three office blood pressure readings.
  • Stable drug regimen including three or more anti-hypertensive medications including a diuretic

Exclusion criteria

Exclusion Criteria:

  • Renal anatomy unsuitable for treatment
  • Presence of hemodynamically significant valvular heart disease for which reduction of blood pressure would be considered hazardous
  • Patient has Type I diabetes
  • Has scheduled or planned surgery within the next 6 months
  • Individual is pregnant nursing or plans to be pregnant
05

Study design

Phase
Phase 2 / Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
0 participants (actual)

Study arms

  • Experimental
    Renal Denervation

    Subjects randomized to the Renal Denervation arm will receive bilateral renal ablation with the OneShot system and be maintained on antihypertensive medication.

    Device: Renal Denervation (OneShot™ Renal Denervation System)

  • No intervention
    Optimal Medical Therapy

    Subjects randomized to the control arm will be maintained on antihypertensive medications.

Interventions

  • DeviceRenal Denervation (OneShot™ Renal Denervation System)

    Also known as: OneShot Ablation system, Catheter-based renal denervation

06

What researchers measure

Primary outcomes

  1. Major adverse event (MAE) rate through 30 days post randomization

    Time frame: 30 days

  2. Change in office systolic blood pressure (SBP) from baseline to 6 months post-randomization

    Time frame: 6 months

Secondary outcomes

  1. Acute Procedural Safety

    Time frame: 30 days

  2. Chronic procedural safety

    Time frame: 6 months

  3. Reduction in SBP by >10 mmHg at 6 months

    Time frame: 6 months

  4. Changes in office SBP and diastolic blood pressure (DBP) from baseline to follow-up visits

    Time frame: 6, 12, 24, and 36 months

07

Study locations

1 site
  • Hospital San Raffaele
    Milano, Italy
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 18, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01939392
Lead sponsor
Medtronic Endovascular
Responsible party
Sponsor
First posted
Sep 11, 2013
Start date
Sep 2013
Primary completion
Sep 2015 (estimated)
Completion
Sep 2018 (estimated)
Last update
Aug 18, 2015

Study contacts

Dierk Scheinert, MD
principal investigator · Park-Krankenhaus Liepzig
Guiseppe Mancia, MD
principal investigator · Universita Minano-Bicocca, Ospedale San Gerardo di Monza

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Aug 2015. You cannot join it, but the record below documents what was studied.

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