Treatment of Resistant Hypertension Using a Radiofrequency Percutaneous Transluminal Angioplasty Catheter (REDUCE-HTN)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Boston Scientific Corporation
ClinicalTrials.gov Identifier:
NCT01541865
First received: February 21, 2012
Last updated: April 4, 2014
Last verified: April 2014
  Purpose

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 RF balloon catheter renal denervation device.


Condition Intervention
Hypertension
Device: Renal Denervation

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Treatment of Resistant Hypertension Using a Radiofrequency Percutaneous Transluminal Angioplasty Catheter (REDUCE-HTN) - POST MARKET APPROVAL CLINICAL SURVEILLANCE STUDY

Resource links provided by NLM:


Further study details as provided by Boston Scientific Corporation:

Primary Outcome Measures:
  • A change in systolic and diastolic blood pressure [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Reduction of systolic and diastolic blood pressure at six (6) months as measured by office-based blood pressure assessment following therapeutic renal denervation compared to baseline. Office blood pressure will be measured using a validated electronic device according to a standardized procedure. Reduction of systolic and diastolic blood pressure at six (6) months as measured by 24-hour ambulatory blood pressure monitoring following therapeutic renal denervation compared to baseline.


Secondary Outcome Measures:
  • Absence of flow limiting stenosis in the renal artery [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    Absence of flow limiting stenosis in the renal artery at six (6) months follow up time point as measured by renal duplex ultrasound


Estimated Enrollment: 150
Study Start Date: February 2012
Estimated Study Completion Date: May 2015
Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
single arm
single arm cohort study
Device: Renal Denervation
percutaneous renal denervation using the Vessix RF balloon catheter
Other Name: Vessix V2 Renal Denervation System

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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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 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 eGFR ≥ 45 ml/min per 1.73m2;
  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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01541865

Locations
Australia, New South Wales
St. Vincent's Hospital
Sydney, New South Wales, Australia, 2010
Australia, Queensland
The Prince Charles Hospital, Cardiology Clinical Research Centre
Brisbane, Queensland, Australia, 4032
Australia, South Australia
Royal Adelaide Hospital
Adelaide, South Australia, Australia, 5000
Flinders Medical Centre
Bedford Park, South Australia, Australia, 5042
Australia, Victoria
Monash Cardiovascular Research Centre (Monash Heart)
Clayton, Victoria, Australia, 3168
Austria
AKH Linz
Linz, Austria, 4020
Salzburger Landeskliniken Universitats Krankenhaus
Salzburg, Austria, A-5020
Belgium
OLV Ziekenhuis
Aalst, Belgium
Cliniques Universiaires Saint-Luc
Brussels, Belgium
France
Hôpital Européen Georges Pompidou
Paris, France
Clinic Pasteur
Toulouse, France, F-31076
Germany
Zentralklinik Bad Berka GmbH
Bad Berka, Germany, 99437
Kardiologische Praxis Main-Taunus
Bad Soden/Taunus, Germany, 65812
Vascular Center Berlin, Ev. Königin Elisabeth Hospital
Berlin, Germany, 10365
St. Vincenz Krankenhaus Abt. Kardiologie
Essen, Germany, 45141
CardioVascular Center, Sankt Katharinen Krakenhaus
Frankfurt, Germany, 60389
Hamburg University Cardiovascular Center
Hamburg, Germany, 22527
Saarland University Hospital Department of Internal Medicine III Non-surgical Intensive Care, Cardiology and Angiology
Homburg/Saar, Germany, D-66421
Leipzig Heart Center
Leipzig, Germany, 04289
German Heart Center Munich
Münich, Germany, 80636
Netherlands
Academic Medical Center
Amsterdam, Netherlands, 1105AZ
Erasmus Medical Center-Thorax Center
Rotterdam, Netherlands, 3015CE
New Zealand
Auckland City Hospital
Grafton, Auckland, New Zealand, 1023
Mercy Angiography Unit Ltd
Auckland, New Zealand, 1023
Switzerland
University Hospital of Geneva, Cardiology Center
Geneva, Switzerland, 1211
Switzerland University Hospital Clinic for Cardiology
Zürich, Switzerland, 8091
Sponsors and Collaborators
Boston Scientific Corporation
Investigators
Principal Investigator: Horst Sievert, M.D. CardioVascular Center Frankfurt, Germany
  More Information

No publications provided by Boston Scientific Corporation

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Boston Scientific Corporation
ClinicalTrials.gov Identifier: NCT01541865     History of Changes
Other Study ID Numbers: CR002-020
Study First Received: February 21, 2012
Last Updated: April 4, 2014
Health Authority: Austria: BASG/AGES PharmMed

Keywords provided by Boston Scientific Corporation:
hypertension, renal denervation, uncontrolled hypertension, medication resistant hypertension

Additional relevant MeSH terms:
Hypertension
Cardiovascular Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on October 23, 2014