HypertensionPhase 2/3NCT01844037

OneShot Renal Denervation Registry

A Phase 2/3 study testing OneShot Ablation System in people with Hypertension and Heart Failure, run by Medtronic Endovascular at 1 site in Italy.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

This is a multi-center, prospective registry designed to monitor the outcomes of renal denervation with the OneShot Device in a real-world patient population. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Hypertension, Heart Failure, Diabetes Mellitus
What is being tested?: OneShot Ablation System
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 51 participants
Where: 1 siteItaly
Study dates: Jul 2014to Mar 2015
Phase: Phase 2/3
Are there results?: None posted in the registry

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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Patient is an acceptable candidate for renal denervation based upon the Instructions for Use.
Patient is ≥ 18 years old.
Patient provided written informed consent.

Who cannot join

Patients who are pregnant, nursing, or planning to become pregnant.
Patients who have only one functioning kidney.
Allergy to contrast or known hypersensitivity to device materials
Patients with renal arteries < 4 mm in diameter.
Patients whose life expectancy is less than the planned period of study involvement.

Trial locations and contacts

1 site in 1 country.

Italy1 site

Hospital San Raffaele
Milan

Other trials in Italy

About this study

Official title: Renal Denervation Using the OneShot Ablation System

This is a multi-center, prospective registry designed to monitor the outcomes of renal denervation with the OneShot Device in a real-world patient population.

Conditions: Hypertension, Heart Failure, Diabetes Mellitus, Sleep Apnea
Being tested: OneShot Ablation System
Medical subject headings: Hypertension, Heart Failure, Diabetes Mellitus, Sleep Apnea Syndromes

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

OneShot Ablation SystemDevice
Renal denervation

Study groups in NCT01844037
Study group	Role	What they receive
Renal denervation	Other	Patients will be treated with the OneShot ablation system Receives: Device: OneShot Ablation System

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in office systolic blood pressure (SBP) from baseline to 6 months
Measured: 6 months

Secondary outcomes (3)

Acute procedural safety, defined as freedom from renal artery dissection or perforation requiring intervention.
Measured: One Week
Change in office diastolic blood pressure (DBP)
Measured: 6 and 12 months post procedure
Change in office SBP
Measured: 6 and 12 months post procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jul 2014Mar 2015

First posted1 May 2013 (estimated)
Study startJul 2014
Primary completionMar 2015
Study completionMar 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for HypertensionStudies 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 2/3
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 51 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01844037
Sponsor's protocol ID: CP1002
Status last verified: Aug 2015
First submitted: 29 Apr 2013
Last updated: 2 Sep 2015
Results posted: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Active, not recruitingPhase 3
Open-Label Extension (OLE) Study to Assess Safety, Efficacy, and Tolerability of Lorundrostat in Subjects With Hypertension
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RecruitingPhase 4
Effectiveness of Two Aspirin Doses for Prevention of Hypertensive Disorders of Pregnancy: ASPIRIN TRIAL
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RecruitingPhase 3
An Open-Label Extension Study of Treprostinil Palmitil Inhalation Powder (TPIP) in Participants With Pulmonary Hypertension Associated With Interstitial Lung Disease (PH-ILD)
Pulmonary Hypertension, Interstitial Lung Disease
RecruitingPhase 2
A Clinical Trial of NS-863 in Participants With Pulmonary Hypertension Associated With Interstitial Lung Disease (PH-ILD)
Pulmonary Hypertension Associated With Interstitial Lung Disease (PH-ILD)

All Hypertension trials

Study at a glance

From the registry record, last updated by the sponsor on 2 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Renal Denervation Using the OneShot Ablation System
ClinicalTrials.gov ID: NCT01844037
Acronym / sponsor ID: CP1002
Conditions: Hypertension, Heart Failure, Diabetes Mellitus, Sleep Apnea
Phase: Phase 2/3
Study type: Interventional
Recruitment status: Terminated
Enrolment: 51 participants (actual)
Lead sponsor: Medtronic EndovascularIndustry (pharma, biotech, devices)
Study start: Jul 2014
Primary completion: Mar 2015 (actual)
Study completion: Mar 2015 (actual)
First posted: 1 May 2013 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

This is a multi-center, prospective registry designed to monitor the outcomes of renal denervation with the OneShot Device in a real-world patient population.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Renal denervation	Other	Device: OneShot Ablation SystemPatients will be treated with the OneShot ablation system

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Patient is an acceptable candidate for renal denervation based upon the Instructions for Use.
Patient is ≥ 18 years old.
Patient provided written informed consent.

Key exclusion criteria (5 listed)

Patients who are pregnant, nursing, or planning to become pregnant.
Patients who have only one functioning kidney.
Allergy to contrast or known hypersensitivity to device materials
Patients with renal arteries < 4 mm in diameter.
Patients whose life expectancy is less than the planned period of study involvement.

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
OneShot Ablation SystemRenal denervation	Device	Renal denervation

Primary outcome

Change in office systolic blood pressure (SBP) from baseline to 6 months
Time frame: 6 months

3 secondary outcomes

Acute procedural safety, defined as freedom from renal artery dissection or perforation requiring intervention.
Time frame: One Week
Change in office diastolic blood pressure (DBP)
Time frame: 6 and 12 months post procedure
Change in office SBP
Time frame: 6 and 12 months post procedure

Results and safety

The study was stopped early. Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2015.

Related trials for Hypertension

RecruitingPhase 1
Study of Intravenous ZMA001 in Healthy Subjects
Pulmonary Arterial Hypertension PAH
Active, not recruitingPhase 3
Open-Label Extension (OLE) Study to Assess Safety, Efficacy, and Tolerability of Lorundrostat in Subjects With Hypertension
Hypertension
RecruitingPhase 4
Effectiveness of Two Aspirin Doses for Prevention of Hypertensive Disorders of Pregnancy: ASPIRIN TRIAL
Hypertensive Disorders of Pregnancy, Preeclampsia
RecruitingPhase 3
An Open-Label Extension Study of Treprostinil Palmitil Inhalation Powder (TPIP) in Participants With Pulmonary Hypertension Associated With Interstitial Lung Disease (PH-ILD)
Pulmonary Hypertension, Interstitial Lung Disease
RecruitingPhase 2
A Clinical Trial of NS-863 in Participants With Pulmonary Hypertension Associated With Interstitial Lung Disease (PH-ILD)
Pulmonary Hypertension Associated With Interstitial Lung Disease (PH-ILD)

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.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing OneShot Ablation System in people with Hypertension and Heart Failure, run by Medtronic Endovascular at 1 site in Italy.

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 5 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: stopped early, as of the sponsor's last update on 2 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. 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.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early. Results are not available in the source record.

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?

Change in office systolic blood pressure (SBP) from baseline to 6 months (time frame: 6 months). 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 NCT01844037.

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 2 Sep 2015; AzTrials last refreshed its copy on 28 Oct 2026.