Rapid Renal Sympathetic Denervation for Resistant Hypertension (RAPID)
This study is currently recruiting participants.
Verified January 2013 by Maya Medical
Sponsor:
Maya Medical
Collaborators:
Covidien
Meditrial Europe LTD
Information provided by (Responsible Party):
Maya Medical
ClinicalTrials.gov Identifier:
NCT01520506
First received: January 25, 2012
Last updated: January 12, 2013
Last verified: January 2013
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Hypertension, Resistant to Conventional Therapy |
Device: Covidien OneShot System |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Rapid Renal Sympathetic Denervation for Resistant Hypertension Using the OneShot™ Ablation System |
Resource links provided by NLM:
Further study details as provided by Maya Medical:
Primary Outcome Measures:
- Acute Procedural Safety [ Time Frame: One Week ] [ Designated as safety issue: Yes ]
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.
Secondary Outcome Measures:
- Chronic Procedural Safety [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]Chronic Procedural Safety, defined as the overall rate of Serious Adverse Events and Adverse Device Effects at 6 months
- RDN Procedure Effectiveness [ Time Frame: 6 months ] [ Designated as safety issue: No ]Procedural Effectiveness, defined as rate of Office Systolic Blood Pressure (SBP) reduction > 10 mmHg at 6 months compared to baseline
| Estimated Enrollment: | 50 |
| Study Start Date: | May 2012 |
| Estimated Study Completion Date: | March 2015 |
| Estimated Primary Completion Date: | November 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Rapid Renal Denervation |
Device: Covidien OneShot System
Placed percutaneously, the OneShotTM 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.
Other Name: Covidien OneShot Renal Denervation System
|
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.
Eligibility| Ages Eligible for Study: | 18 Years to 85 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
- eGFR < 45 mL/min per 1.73 m2.
- Type 1 diabetes mellitus.
- 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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01520506
Contacts
| Contact: Monica Tocchi, MD,PhD | 00393931155344 | medical@meditrialeurope.com |
Locations
| Belgium | |
| Middelheim Hospital | Recruiting |
| Antwerp, Belgium | |
| Contact: Nancy Aerts nancy.aerts@zna.be | |
| Principal Investigator: Stefan Verheye, MD | |
| Ziekenhuis Oost--Limburg | Recruiting |
| Genk, Belgium, 3600 | |
| Contact: Joseph Dens, MD Jo.Dens@zol.be | |
| Principal Investigator: Joseph Dens, MD | |
| Germany | |
| Universitatklinikum | Recruiting |
| Bonn, Germany | |
| Contact: Nikos Werner nwerner@uni-bonn.de | |
| Principal Investigator: Eberhard Grube, MD | |
| Cardiovascular Center Sankt Katharinen | Recruiting |
| Frankfurt, Germany | |
| Contact: R Eckhardt r.eckhardt@cvcfrankfurt.de | |
| Principal Investigator: Horst Sievert, MD | |
| Asklepios Klinik St. Georg | Recruiting |
| Hamburg, Germany | |
| Contact: Karl Heinz Kuck, MD KuckKH@aol.com | |
| Principal Investigator: Karl Heinz Kuck, MD | |
| Univ. Medical Klinik III | Recruiting |
| Heidelberg, Germany | |
| Contact: Erwin Blessing, MD | |
| Principal Investigator: Erwin Blessing, MD | |
| Franziskus Hospital | Recruiting |
| Münster, Germany | |
| Contact: Giovanni Torsello, MD | |
| Principal Investigator: Giovanni Torsello | |
| Italy | |
| Hospital San Raffaele | Recruiting |
| Milano, Italy | |
| Contact: Antonio Colombo, MD | |
| Principal Investigator: Antonio Colombo, MD | |
| Luxembourg | |
| Centre Hospitalier De Luxembourg | Recruiting |
| Luxembourg, Luxembourg, L-1210 | |
| Contact: Daniel Wagner wagner.daniel@chl.lu | |
| Principal Investigator: Daniel Wagner, MD | |
| Netherlands | |
| Santa Catharina Hospital | Recruiting |
| Eindhoven, Netherlands | |
| Contact: Antoinette van der Pol antoinette.vd.pol@catharinaziekenhuis.nl | |
| Principal Investigator: W.A.L. Tonino | |
| St. Antonius Ziekenhuis | Recruiting |
| Nieuwegein, Netherlands | |
| Contact: Benno Rensing, MD b.rensing@antoniusziekenhuis.nl | |
| Principal Investigator: Benno Rensing, MD | |
| Erasmus MC Thoraxcenter | Not yet recruiting |
| Rotterdam, Netherlands | |
| Contact: Joost Daemen j.daemen@erasmusmc.nl | |
| Principal Investigator: Joost Daemen, MD | |
| UMC Universitair Medisch Centrum | Recruiting |
| Utrecht, Netherlands | |
| Contact: Michiel Voskuil, MD m.voskuil@umcutrecht.nl | |
| Principal Investigator: Michiel Voskuil, MD | |
| New Zealand | |
| Mercy Angiography Unit | Recruiting |
| Auckland, New Zealand | |
| Contact: Rhona MacDonald rhona@mercyangiography.co.nz | |
| Principal Investigator: John Ormiston | |
Sponsors and Collaborators
Maya Medical
Covidien
Meditrial Europe LTD
Investigators
| Principal Investigator: | W.A.L. Tonino, MD | Department of Cardiology, Catherina Hospital, Eindhoven, The Netherlands |
| Principal Investigator: | Stefan Verheye, MD | Department of Interventional Cardiology, Middelheim Hospital, Antwerp, Belgium |
More Information
Additional Information:
No publications provided
| Responsible Party: | Maya Medical |
| ClinicalTrials.gov Identifier: | NCT01520506 History of Changes |
| Other Study ID Numbers: | CIP 012 |
| Study First Received: | January 25, 2012 |
| Last Updated: | January 12, 2013 |
| Health Authority: | Netherlands: Medical Ethics Review Committee (METC) Netherlands: The Central Committee on Research Involving Human Subjects (CCMO) |
Keywords provided by Maya Medical:
|
Hypertension Kidney Diseases Kidney Failure, Chronic Vascular Diseases |
Cardiovascular Diseases Urologic Diseases Renal Insufficiency, Chronic Renal Insufficiency |
Additional relevant MeSH terms:
|
Hypertension Vascular Diseases Cardiovascular Diseases |
ClinicalTrials.gov processed this record on June 18, 2013