Treatment of Resistant Hypertension Using a Radiofrequency Percutaneous Transluminal Angioplasty Catheter

Hypertension Clinical Trial

— REDUCE-HTN  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01541865
• Other study ID #: CR002-020
• Status: Completed
• Phase: N/A
• First received: February 21, 2012
• Last updated: October 23, 2015
• Start date: February 2012
• Est. completion date: June 2015

Study information

• Verified date: October 2015
• Source: Boston Scientific Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: BASG/AGES PharmMed
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 146
• Est. completion date: June 2015
• Est. primary completion date: November 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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 Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypertension

Intervention

Device:
• Renal Denervation
percutaneous renal denervation using the Vessix RF balloon catheter

Locations

Country	Name	City	State
Australia	Royal Adelaide Hospital	Adelaide	South Australia
Australia	Flinders Medical Centre	Bedford Park	South Australia
Australia	The Prince Charles Hospital, Cardiology Clinical Research Centre	Brisbane	Queensland
Australia	Monash Cardiovascular Research Centre (Monash Heart)	Clayton	Victoria
Australia	St. Vincent's Hospital	Sydney	New South Wales
Austria	AKH Linz	Linz
Austria	Salzburger Landeskliniken Universitats Krankenhaus	Salzburg
Belgium	OLV Ziekenhuis	Aalst
Belgium	Cliniques Universiaires Saint-Luc	Brussels
France	Hôpital Européen Georges Pompidou	Paris
France	Clinic Pasteur	Toulouse
Germany	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
Netherlands	Academic Medical Center	Amsterdam
Netherlands	Erasmus Medical Center-Thorax Center	Rotterdam
New Zealand	Mercy Angiography Unit Ltd	Auckland
New Zealand	Auckland City Hospital	Grafton	Auckland
Switzerland	University Hospital of Geneva, Cardiology Center	Geneva
Switzerland	Switzerland University Hospital Clinic for Cardiology	Zürich

Sponsors (1)

Lead Sponsor	Collaborator
Boston Scientific Corporation

Countries where clinical trial is conducted

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

References & Publications (2)

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. — View 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 R — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Secondary	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	Yes
Secondary	Renal Artery Dissection or Perforation During the Procedure That Requires Stenting or Surgery		Duration of the procedure (average of 65 minutes)	Yes
Secondary	Renal Artery Infarction or Embolus		Duration of the procedure (average of 65 minutes)	Yes
Secondary	Cerebrovascular Accident (CVA) at Time of Procedure		Duration of the procedure (average of 65 minutes)	Yes
Secondary	Myocardial Infarction at Time of Procedure		Duration of the procedure (average of 65 minutes)	Yes
Secondary	Sudden Cardiac Death at Time of Procedure		Duration of the procedure (average of 65 minutes)	Yes
Secondary	Angiographically-documented Renal Stenosis Requiring an Intervention		2 Years	Yes
Secondary	Chronic Symptomatic Orthostatic Hypotension		2 Years	Yes
Secondary	Hypertensive Emergency Necessitating Hospital Admission (Unrelated to Medication and/or Non-compliance)		2 Years	Yes
Secondary	Reduction in Estimated Glomerular Filtration Rate (eGFR) >25%		2 Years	Yes