Clinical trial NCT01541865: Treatment of Resistant Hypertension Using a Radiofrequency Percutaneous Transluminal Angioplasty Catheter
Official title: Treatment of Resistant Hypertension Using a Radiofrequency Percutaneous Transluminal Angioplasty Catheter (REDUCE-HTN) - POST MARKET APPROVAL CLINICAL SURVEILLANCE STUDY
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension
Keywords: hypertension, renal denervation, uncontrolled hypertension, medication resistant hypertension
Lead sponsor: Boston Scientific Corporation
Sponsor class: INDUSTRY
First posted: 2012-03-01
Enrollment: 146
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Change in Systolic and Diastolic Blood Pressure at Six (6) Months as Measured by Office-based Blood Pressure Assessment
timeFrame: Baseline and 6 months
measure: Change in Systolic and Diastolic Blood Pressure at Six (6) Months as Measured by 24-hour Ambulatory Blood Pressure
timeFrame: Baseline and 6 months
Secondary outcomes:
measure: Absence of Flow Limiting Stenosis in the Renal Artery
timeFrame: 6 months
measure: Renal Artery Dissection or Perforation During the Procedure That Requires Stenting or Surgery
timeFrame: Duration of the procedure (average of 65 minutes)
measure: Renal Artery Infarction or Embolus
timeFrame: Duration of the procedure (average of 65 minutes)
measure: Cerebrovascular Accident (CVA) at Time of Procedure
timeFrame: Duration of the procedure (average of 65 minutes)
measure: Myocardial Infarction at Time of Procedure
timeFrame: Duration of the procedure (average of 65 minutes)
measure: Sudden Cardiac Death at Time of Procedure
timeFrame: Duration of the procedure (average of 65 minutes)
measure: Angiographically-documented Renal Stenosis Requiring an Intervention
timeFrame: 2 Years
measure: Chronic Symptomatic Orthostatic Hypotension
timeFrame: 2 Years
measure: Hypertensive Emergency Necessitating Hospital Admission (Unrelated to Medication and/or Non-compliance)
timeFrame: 2 Years
measure: Reduction in Estimated Glomerular Filtration Rate (eGFR) >25%
timeFrame: 2 Years
Other outcomes:
Locations:
city: Sydney
country: Australia
facility: St. Vincent's Hospital
state: New South Wales
city: Brisbane
country: Australia
facility: The Prince Charles Hospital, Cardiology Clinical Research Centre
state: Queensland
city: Adelaide
country: Australia
facility: Royal Adelaide Hospital
state: South Australia
city: Bedford Park
country: Australia
facility: Flinders Medical Centre
state: South Australia
city: Clayton
country: Australia
facility: Monash Cardiovascular Research Centre (Monash Heart)
state: Victoria
city: Linz
country: Austria
facility: AKH Linz
city: Salzburg
country: Austria
facility: Salzburger Landeskliniken Universitats Krankenhaus
city: Aalst
country: Belgium
facility: OLV Ziekenhuis
city: Brussels
country: Belgium
facility: Cliniques Universiaires Saint-Luc
city: Paris
country: France
facility: Hôpital Européen Georges Pompidou
city: Toulouse
country: France
facility: Clinic Pasteur
city: Bad Berka
country: Germany
facility: Zentralklinik Bad Berka GmbH
city: Bad Soden/Taunus
country: Germany
facility: Kardiologische Praxis Main-Taunus
city: Berlin
country: Germany
facility: Vascular Center Berlin, Ev. Königin Elisabeth Hospital
city: Essen
country: Germany
facility: St. Vincenz Krankenhaus Abt. Kardiologie
city: Frankfurt
country: Germany
facility: CardioVascular Center, Sankt Katharinen Krakenhaus
city: Hamburg
country: Germany
facility: Hamburg University Cardiovascular Center
city: Homburg/Saar
country: Germany
facility: Saarland University Hospital Department of Internal Medicine III Non-surgical Intensive Care, Cardiology and Angiology
city: Leipzig
country: Germany
facility: University Leipzig
city: Münich
country: Germany
facility: German Heart Center Munich
city: Amsterdam
country: Netherlands
facility: Academic Medical Center
city: Rotterdam
country: Netherlands
facility: Erasmus Medical Center-Thorax Center
city: Grafton
country: New Zealand
facility: Auckland City Hospital
state: Auckland
city: Auckland
country: New Zealand
facility: Mercy Angiography Unit Ltd
city: Geneva
country: Switzerland
facility: University Hospital of Geneva, Cardiology Center
city: Zürich
country: Switzerland
facility: Switzerland University Hospital Clinic for Cardiology
Study officials:
affiliation: CardioVascular Center Frankfurt, Germany
name: Horst Sievert, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.