Hypertension, Resistant to Conventional TherapyRAPIDNCT01520506
Rapid Renal Sympathetic Denervation for Resistant Hypertension
A study testing Covidien OneShot™ System in people with Hypertension, Resistant to Conventional Therapy, run by Medtronic Endovascular at 14 sites in 6 countries.
Trial summary
The Covidien OneShot™ ablation system use is to deliver low-level radio frequency (RF) energy through the wall of the renal artery to denervate the human kidney. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Hypertension, Resistant to Conventional Therapy
- What is being tested?
- Covidien OneShot™ System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 14 sitesin 6 countries
- Study dates
- May 2012to Jun 2014
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Systolic blood pressure ≥ 160 mmHg despite treatment with a regimen of 3 or more anti-hypertensive medications that includes a diuretic and that has been stable for 2 weeks prior to screening.
- Age 18-85 years.
- Able to provide informed consent and comply with follow-up visits.
Who cannot join
- Diameter of left or right renal artery less than 4 mm or greater than 7mm.
- Length of target segment of left or right renal artery less than 20mm.
- Other renal arterial abnormalities including severe renal artery stenosis, previous renal stenting or angioplasty.
- End-stage renal disease requiring dialysis or renal transplant.
- estimated Glomerular Filtration Rate < 45 mL/min per 1.73 m2.
- Type 1 diabetes mellitus.
Show all 13Show fewer
- Myocardial infarction, unstable angina, or cerebrovascular events within 6 months prior to screening.
- Severe valvular heart disease for which reduction of blood pressure would be considered hazardous.
- Bleeding disorder or refusing blood transfusions.
- Pregnancy or breast feeding.
- Peripheral vascular disease precluding catheter insertion.
- Any serious medical condition, which in the opinion of the investigator, may adversely affect the safety or effectiveness of the participant or the study.
- Current enrollment in another investigational drug or device Study.
Trial locations and contacts
14 sites in 6 countries.
14 sites in 6 countries
Germany5 sites
Universitatklinikum
Bonn
Cardiovascular Center Sankt Katharinen
Frankfurt
Asklepios Klinik St. Georg
Hamburg
Univ. Medical Klinik III
Heidelberg
Franziskus Hospital
Münster
Netherlands4 sites
Santa Catharina Hospital
Eindhoven
St. Antonius Ziekenhuis
Nieuwegein
Erasmus MC Thoraxcenter
Rotterdam
UMC Universitair Medisch Centrum
Utrecht
About this study
Official title: Rapid Renal Sympathetic Denervation for Resistant Hypertension Using the OneShot™ Ablation System
The Covidien OneShot™ ablation system use is to deliver low-level radio frequency (RF) energy through the wall of the renal artery to denervate the human kidney.
Read the detailed description
Unique to the OneShot™ ablation system is the ability to deliver the desired helical treatment pattern for optimal Renal Denervation (RDN) with a single balloon based-treatment, eliminating user variance inherent in the currently available point-by-point approach. In addition, technological improvements have been incorporated. The OneShot™ RF generator has a touchscreen, user friendly interface; catheter advancement is made safer with the use of a guidewire; two radiopaque markers on the catheter enable more precise device positioning; and the irrigated catheter tip reduces the risk of overheating and clot formation during RF delivery. By offering a more reliable single treatment approach, coupled with enhanced ease-of use and reduced procedure times, this technology has the potential to significantly expand clinical adoption of catheter-based renal sympathetic denervation.
- Being tested
- Covidien OneShot™ System
- Keywords
- Hypertension, Kidney Diseases, Kidney Failure, Chronic, Vascular Diseases, Cardiovascular Diseases, Urologic Diseases, Renal Insufficiency, Chronic, Renal Insufficiency
- Medical subject headings
- Hypertension Resistant to Conventional Therapy, Hypertension, Kidney Diseases, Kidney Failure, Chronic, Vascular Diseases, Cardiovascular Diseases, Urologic Diseases, Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Covidien OneShot™ SystemDevice
Also called Covidien OneShot™ Renal Denervation System
Placed percutaneously, the OneShot™ balloon catheter is advanced into the renal artery using a routine femoral approach in a cardiac catheterization laboratory setting. RF is applied with pre-programmed time and intensity in each of the renal arteries.
| Study group | Role | What they receive |
|---|---|---|
| Rapid Renal Denervation | Experimental | Not described Receives: Device: Covidien OneShot™ System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acute Procedural Safety
Acute Procedural Safety, defined as the overall rate of Serious Adverse Events (SAE's) and adverse device effects at discharge:
- SAE's related to groin and vascular access complications, and
- SAE's related to renal artery injury.
Measured: One Week
Secondary outcomes (2)
Chronic Procedural Safety
Chronic Procedural Safety, defined as the overall rate of Serious Adverse Events and Adverse Device Effects at 6 months
Measured: 6 months
Renal Denervation Procedure Effectiveness
Procedural Effectiveness, defined as rate of Office Systolic Blood Pressure (SBP) reduction > 10 mmHg at 6 months compared to baseline
Measured: From baseline to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2012 (estimated)
- Study startMay 2012
- Primary completionNov 2013
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hypertension, Resistant to Conventional TherapyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic Endovascular
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Medtronic - MITG, Meditrial Europe Ltd.
- Responsible party
- Sponsor
- Investigators
- W.A.L. Tonino, MD, Principal investigator, Department of Cardiology, Catherina Hospital, Eindhoven, The NetherlandsStefan Verheye, MD, Principal investigator, Department of Interventional Cardiology, Middelheim Hospital, Antwerp, Belgium
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01520506
- Sponsor's protocol ID
- CIP 012
- Acronym
- RAPID
- Status last verified
- Feb 2019
- First submitted
- 25 Jan 2012
- Last updated
- 1 Mar 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Verheye S, Ormiston J, Bergmann MW, Sievert H, Schwindt A, Werner N, Vogel B, Colombo A. Twelve-month results of the rapid renal sympathetic denervation for resistant hypertension using the OneShotTM ablation system (RAPID) study. EuroIntervention. 2015 Feb;10(10):1221-9. doi: 10.4244/EIJY14M12_02.
PubMed 25452198
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rapid Renal Sympathetic Denervation for Resistant Hypertension Using the OneShot™ Ablation System
- ClinicalTrials.gov ID
- NCT01520506
- Acronym / sponsor ID
- RAPID / CIP 012
- Keywords
- Hypertension, Kidney Diseases, Kidney Failure, Chronic, Vascular Diseases, Cardiovascular Diseases, Urologic Diseases, Renal Insufficiency, Chronic, Renal Insufficiency
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Medtronic EndovascularIndustry (pharma, biotech, devices)
- Collaborators
- Medtronic - MITG, Meditrial Europe Ltd.
- Study start
- May 2012
- Primary completion
- Nov 2013 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 30 Jan 2012 (estimated)
- Results
- Posted 16 Sep 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The Covidien OneShot™ ablation system use is to deliver low-level radio frequency (RF) energy through the wall of the renal artery to denervate the human kidney.
Detailed description
Unique to the OneShot™ ablation system is the ability to deliver the desired helical treatment pattern for optimal Renal Denervation (RDN) with a single balloon based-treatment, eliminating user variance inherent in the currently available point-by-point approach. In addition, technological improvements have been incorporated. The OneShot™ RF generator has a touchscreen, user friendly interface; catheter advancement is made safer with the use of a guidewire; two radiopaque markers on the catheter enable more precise device positioning; and the irrigated catheter tip reduces the risk of overheating and clot formation during RF delivery. By offering a more reliable single treatment approach, coupled with enhanced ease-of use and reduced procedure times, this technology has the potential to significantly expand clinical adoption of catheter-based renal sympathetic denervation.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Rapid Renal Denervation | Experimental | Device: Covidien OneShot™ System |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Systolic blood pressure ≥ 160 mmHg despite treatment with a regimen of 3 or more anti-hypertensive medications that includes a diuretic and that has been stable for 2 weeks prior to screening.
- Age 18-85 years.
- Able to provide informed consent and comply with follow-up visits.
Key exclusion criteria (13 listed)
- Diameter of left or right renal artery less than 4 mm or greater than 7mm.
- Length of target segment of left or right renal artery less than 20mm.
- Other renal arterial abnormalities including severe renal artery stenosis, previous renal stenting or angioplasty.
- End-stage renal disease requiring dialysis or renal transplant.
- estimated Glomerular Filtration Rate < 45 mL/min per 1.73 m2.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Covidien OneShot™ SystemAlso: Covidien OneShot™ Renal Denervation SystemPlaced percutaneously, the OneShot™ balloon catheter is advanced into the renal artery using a routine femoral approach in a cardiac catheterization laboratory setting. RF is applied with pre-programmed time and intensity in each of the renal arteries. | Device | Rapid Renal Denervation |
Primary outcome
Acute Procedural Safety
Time frame: One Week
Acute Procedural Safety, defined as the overall rate of Serious Adverse Events (SAE's) and adverse device effects at discharge: * SAE's related to groin and vascular access complications, and * SAE's related to renal artery injury.
2 secondary outcomes
Chronic Procedural Safety
Time frame: 6 months
Renal Denervation Procedure Effectiveness
Time frame: From baseline to 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 25452198Verheye S, Ormiston J, Bergmann MW, Sievert H, Schwindt A, Werner N, Vogel B, Colombo A. Twelve-month results of the rapid renal sympathetic denervation for resistant hypertension using the OneShotTM ablation system (RAPID) study. EuroIntervention. 2015 Feb;10(10):1221-9. doi: 10.4244/EIJY14M12_02.
- Meditrial Europe Ltd CROLink provided by the sponsor.
- Covidien (manufacturer)Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
W.A.L. Tonino, MD principal investigator
Department of Cardiology, Catherina Hospital, Eindhoven, The Netherlands
Stefan Verheye, MD principal investigator
Department of Interventional Cardiology, Middelheim Hospital, Antwerp, Belgium
14 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Covidien OneShot™ System in people with Hypertension, Resistant to Conventional Therapy, run by Medtronic Endovascular at 14 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in Germany, Netherlands, Belgium, Italy, Luxembourg and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 Sep 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acute Procedural Safety (time frame: One Week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01520506, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Mar 2019.