Treatment of Resistant Hypertension Using a Radiofrequency Percutaneous Transluminal Angioplasty Catheter

NCT ID: NCT01541865

Last Updated: 2015-11-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 146 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-02-29
• Study Completion Date: 2015-06-30

Brief Summary

The Study objective is to assess the performance of the Vessix V2 Renal Denervation System for the treatment of uncontrolled hypertension using an innovative percutaneous Radio Frequency (RF) balloon catheter renal denervation device.

Detailed Description

This study will evaluate the hypothesis that the Vessix V2 Renal Denervation System can be employed to reduce systolic and diastolic blood pressure at 6 months as compared to pre-treatment baseline blood pressures.

Patient blood pressure will be measured by in the office according to recognized international techniques and standards.

Procedural success shall be defined as ability to complete the renal denervation treatment using the V2 balloon catheter device and RF generator.

Conditions

Hypertension

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Renal Denvervation

All subjects who meet the inclusion criteria and are enrolled in this trial will be treated with the Vessix Renal Denervation System.

Group Type: OTHER

Renal Denervation

Intervention Type: DEVICE

percutaneous renal denervation using the Vessix RF balloon catheter

Interventions

Renal Denervation

percutaneous renal denervation using the Vessix RF balloon catheter

Intervention Type: DEVICE

Other Intervention Names

Vessix V2 Renal Denervation System

Eligibility Criteria

Inclusion Criteria

1. Subjects who have provided written informed consent;

2. Subjects who are ≥ 18 years and ≤ 75 years of age;

3. Subjects who have Systolic Blood Pressure (SBP) ≥ 160 mm Hg based on an average of three (3) office-based blood pressure readings (seated) measured according to protocol;

4. Subjects with ≥ 3 anti-hypertensive drugs at maximally tolerated doses with stable regimen for at least 2 weeks prior to enrollment

5. Subjects with a estimated glomerular filtration rate (eGFR) ≥ 45 ml/min/1.73m^2;

6. Suitable renal artery anatomy

7. Subjects who are willing and able to comply with all study procedures.

Exclusion Criteria

1. Subjects with known/diagnosed secondary hypertension;

2. Subjects who are contraindicated for anticoagulation medications (heparin, aspirin, Angiomax, etc.), analgesic medications (morphine, fentanyl, etc.), anxiolytic medications (alprazolam, lorazepam, diazepam, etc.) or other medications required for an interventional procedure;

3. Subjects with known bleeding or hyper-coagulation disorders;

4. Subjects who have type 1 diabetes mellitus;

5. Subjects who have experienced a myocardial infarction, unstable angina pectoris, uncompensated heart failure, or a cerebrovascular accident within six (6) months prior to the screening visit, or have widespread atherosclerosis, with documented intravascular thrombosis or unstable plaques;

6. Subjects who have planned percutaneous vascular or surgical intervention for any reason within the next 6 months;

7. Subjects who have hemodynamically significant valvular heart disease for which reduction of blood pressure would be considered hazardous;

8. Subjects who have an implantable cardioverter defibrillator, pacemaker, or clinically significant abnormal electrocardiogram

9. Subjects who have any serious medical condition, which in the opinion of the investigator, may adversely affect patient safety or the efficacy of the procedure in the study (i.e., patients with clinically significant peripheral vascular disease, abdominal aortic aneurysm, bleeding disorders such as thrombocytopenia, hemophilia, or significant anemia);

10. Subjects who are pregnant, nursing or planning to become pregnant;

11. Subjects who have a known, unresolved history of drug use or alcohol abuse/dependency;

12. Subjects who are currently enrolled in any investigational study wherein patient participation has not been completed;

13. Subjects who, for any reason, may not be able to understand or comply with instructions;

14. Subjects who are contraindicated for intravascular contrast material;

15. Subjects who are currently taking estrogen or any estrogen-like compound.

16. Subjects who have had a prior renal denervation procedure

17. Subjects with prior intervention to right or left renal artery;

18. Subjects with ≥ 30% renal artery stenosis

19. Subjects with severe femoral, renal, iliac or aortic calcification that may cause a potential complication at the time of the procedure;

20. Subjects in which the physician is unable to safely cannulate the renal artery;

21. Subjects in which the physician is unable to percutaneously access the femoral artery;

22. Subjects with one kidney.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Boston Scientific Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Horst Sievert, M.D.

Role: PRINCIPAL_INVESTIGATOR

CardioVascular Center Frankfurt, Germany

Locations

St. Vincent's Hospital

Sydney, New South Wales, Australia

The Prince Charles Hospital, Cardiology Clinical Research Centre

Brisbane, Queensland, Australia

Royal Adelaide Hospital

Adelaide, South Australia, Australia

Flinders Medical Centre

Bedford Park, South Australia, Australia

Monash Cardiovascular Research Centre (Monash Heart)

Clayton, Victoria, Australia

AKH Linz

Linz, , Austria

Salzburger Landeskliniken Universitats Krankenhaus

Salzburg, , Austria

OLV Ziekenhuis

Aalst, , Belgium

Cliniques Universiaires Saint-Luc

Brussels, , Belgium

Hôpital Européen Georges Pompidou

Paris, , France

Clinic Pasteur

Toulouse, , France

Zentralklinik Bad Berka GmbH

Bad Berka, , Germany

Kardiologische Praxis Main-Taunus

Bad Soden/Taunus, , Germany

Vascular Center Berlin, Ev. Königin Elisabeth Hospital

Berlin, , Germany

St. Vincenz Krankenhaus Abt. Kardiologie

Essen, , Germany

CardioVascular Center, Sankt Katharinen Krakenhaus

Frankfurt, , Germany

Hamburg University Cardiovascular Center

Hamburg, , Germany

Saarland University Hospital Department of Internal Medicine III Non-surgical Intensive Care, Cardiology and Angiology

Homburg/Saar, , Germany

University Leipzig

Leipzig, , Germany

German Heart Center Munich

Münich, , Germany

Academic Medical Center

Amsterdam, , Netherlands

Erasmus Medical Center-Thorax Center

Rotterdam, , Netherlands

Auckland City Hospital

Grafton, Auckland, New Zealand

Mercy Angiography Unit Ltd

Auckland, , New Zealand

University Hospital of Geneva, Cardiology Center

Geneva, , Switzerland

Switzerland University Hospital Clinic for Cardiology

Zurich, , Switzerland

Countries

Australia; Austria; Belgium; France; Germany; Netherlands; New Zealand; Switzerland

References

Sievert H, Schofer J, Ormiston J, Hoppe UC, Meredith IT, Walters DL, Azizi M, Diaz-Cartelle J, Cohen-Mazor M. Renal denervation with a percutaneous bipolar radiofrequency balloon catheter in patients with resistant hypertension: 6-month results from the REDUCE-HTN clinical study. EuroIntervention. 2015 Feb;10(10):1213-20. doi: 10.4244/EIJY14M12_01.

Reference Type: RESULT

PMID: 25452197 (View on PubMed)

Persu A, Sapoval M, Azizi M, Monge M, Danse E, Hammer F, Renkin J. Renal artery stenosis following renal denervation: a matter of concern. J Hypertens. 2014 Oct;32(10):2101-5. doi: 10.1097/HJH.0000000000000323. No abstract available.

Reference Type: RESULT

PMID: 25186534 (View on PubMed)

Other Identifiers

CR002-020

Identifier Type: -

Identifier Source: org_study_id