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

Treatment of Resistant Hypertension Using a Radiofrequency Percutaneous Transluminal Angioplasty Catheter (REDUCE-HTN) - POST MARKET APPROVAL CLINICAL SURVEILLANCE STUDY

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.

Study Overview

• Status: Completed
• Conditions: Hypertension
• Intervention / Treatment: Device: Renal Denervation

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.

• Study Type: Interventional
• Enrollment (Actual): 146
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Australia
  • New South Wales
    • Sydney, New South Wales, Australia, 2010
      • St. Vincent's Hospital
  • Queensland
    • Brisbane, Queensland, Australia, 4032
      • The Prince Charles Hospital, Cardiology Clinical Research Centre
  • South Australia
    • Adelaide, South Australia, Australia, 5000
      • Royal Adelaide Hospital
    • Bedford Park, South Australia, Australia, 5042
      • Flinders Medical Centre
  • Victoria
    • Clayton, Victoria, Australia, 3168
      • Monash Cardiovascular Research Centre (Monash Heart)
• Austria
  • Linz, Austria, 4020
    • AKh Linz
  • Salzburg, Austria, A-5020
    • Salzburger Landeskliniken Universitats Krankenhaus
• Belgium
  • Aalst, Belgium
    • OLV Ziekenhuis
  • Brussels, Belgium
    • Cliniques Universiaires Saint-Luc
• France
  • Paris, France
    • Hôpital Europeen Georges Pompidou
  • Toulouse, France, F-31076
    • Clinic Pasteur
• Germany
  • Bad Berka, Germany, 99437
    • Zentralklinik Bad Berka GmbH
  • Bad Soden/Taunus, Germany, 65812
    • Kardiologische Praxis Main-Taunus
  • Berlin, Germany, 10365
    • Vascular Center Berlin, Ev. Königin Elisabeth Hospital
  • Essen, Germany, 45141
    • St. Vincenz Krankenhaus Abt. Kardiologie
  • Frankfurt, Germany, 60389
    • CardioVascular Center, Sankt Katharinen Krakenhaus
  • Hamburg, Germany, 22527
    • Hamburg University Cardiovascular Center
  • Homburg/Saar, Germany, D-66421
    • Saarland University Hospital Department of Internal Medicine III Non-surgical Intensive Care, Cardiology and Angiology
  • Leipzig, Germany, 04109
    • University Leipzig
  • Münich, Germany, 80636
    • German Heart Center Munich
• Netherlands
  • Amsterdam, Netherlands, 1105AZ
    • Academic Medical Center
  • Rotterdam, Netherlands, 3015CE
    • Erasmus Medical Center-Thorax Center
• New Zealand
  • Auckland, New Zealand, 1023
    • Mercy Angiography Unit Ltd
  • Auckland
    • Grafton, Auckland, New Zealand, 1023
      • Auckland City Hospital
• Switzerland
  • Geneva, Switzerland, 1211
    • University Hospital of Geneva, Cardiology Center
  • Zürich, Switzerland, 8091
    • Switzerland University Hospital Clinic for Cardiology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Renal Denvervation; All subjects who meet the inclusion criteria and are enrolled in this trial will be treated with the Vessix Renal Denervation System.	Device: Renal Denervation; percutaneous renal denervation using the Vessix RF balloon catheter; Other Names: Vessix V2 Renal Denervation System

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Systolic and Diastolic Blood Pressure at Six (6) Months as Measured by Office-based Blood Pressure Assessment	Change in 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. .	Baseline and 6 months
Change in Systolic and Diastolic Blood Pressure at Six (6) Months as Measured by 24-hour Ambulatory Blood Pressure	Change in systolic and diastolic blood pressure at six (6) months as measured by 24-hour ambulatory blood pressure monitoring (ABPM) following therapeutic renal denervation compared to baseline using a validated ABPM device.	Baseline and 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Absence of Flow Limiting Stenosis in the Renal Artery	Absence of flow limiting stenosis in the renal artery at six (6) months follow up time point as measured by renal duplex ultrasound	6 months
Renal Artery Dissection or Perforation During the Procedure That Requires Stenting or Surgery		Duration of the procedure (average of 65 minutes)
Renal Artery Infarction or Embolus		Duration of the procedure (average of 65 minutes)
Cerebrovascular Accident (CVA) at Time of Procedure		Duration of the procedure (average of 65 minutes)
Myocardial Infarction at Time of Procedure		Duration of the procedure (average of 65 minutes)
Sudden Cardiac Death at Time of Procedure		Duration of the procedure (average of 65 minutes)
Angiographically-documented Renal Stenosis Requiring an Intervention		2 Years
Chronic Symptomatic Orthostatic Hypotension		2 Years
Hypertensive Emergency Necessitating Hospital Admission (Unrelated to Medication and/or Non-compliance)		2 Years
Reduction in Estimated Glomerular Filtration Rate (eGFR) >25%		2 Years

Collaborators and Investigators

• Sponsor: Boston Scientific Corporation
• Investigators: Principal Investigator: Horst Sievert, M.D., Cardiovascular Center Frankfurt, Germany

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: February 1, 2012
• Primary Completion (Actual): November 1, 2013
• Study Completion (Actual): June 1, 2015

Study Registration Dates

• First Submitted: February 21, 2012
• First Submitted That Met QC Criteria: February 27, 2012
• First Posted (Estimate): March 1, 2012

Study Record Updates

• Last Update Posted (Estimate): November 25, 2015
• Last Update Submitted That Met QC Criteria: October 23, 2015
• Last Verified: October 1, 2015

More Information

Terms related to this study

• Keywords: hypertension, renal denervation, uncontrolled hypertension, medication resistant hypertension
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension
• Other Study ID Numbers: CR002-020