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

• ClinicalTrials.gov Identifier: NCT01541865
• Recruitment Status: Completed
• First Posted: March 1, 2012
• Results First Posted: October 16, 2015
• Last Update Posted: November 25, 2015
• Sponsor: Boston Scientific Corporation
• Information provided by (Responsible Party): Boston Scientific Corporation

Tracking Information

• First Submitted Date: February 21, 2012
• First Posted Date: March 1, 2012
• Results First Submitted Date: September 15, 2015
• Results First Posted Date: October 16, 2015
• Last Update Posted Date: November 25, 2015
• Study Start Date: February 2012
• Actual Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: October 23, 2015)

• Change in Systolic and Diastolic Blood Pressure at Six (6) Months as Measured by Office-based Blood Pressure Assessment [ Time Frame: Baseline and 6 months ]
  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. .
• Change in Systolic and Diastolic Blood Pressure at Six (6) Months as Measured by 24-hour Ambulatory Blood Pressure [ Time Frame: Baseline and 6 months ]
  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.

Original Primary Outcome Measures (submitted: February 27, 2012)

Acute safety of the procedure [ Time Frame: 24 hours ]

Acute safety of the renal denervation procedure shall be determined based on no renal artery dissection or perforation during the procedure that requires stenting or surgery; no renal artery infarction or embolus; no cerebrovascular Accident and no myocardial infarction and no sudden cardiac death at the time of the procedure or the following 24 hours.

Current Secondary Outcome Measures (submitted: October 23, 2015)

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

Original Secondary Outcome Measures (submitted: February 27, 2012)

A change in systolic and diastolic blood pressure [ Time Frame: 6 months ]

Reduction of systolic and diastolic blood pressure at six (6) months as measured by office-based blood pressure assessment (seated) 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.

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: 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
• 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.

• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Hypertension

Intervention

Device: Renal Denervation

percutaneous renal denervation using the Vessix RF balloon catheter

Other Name: Vessix V2 Renal Denervation System

Study Arms

Renal Denvervation

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

Intervention: Device: Renal Denervation

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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: July 3, 2015): 146
• Original Estimated Enrollment (submitted: February 27, 2012): 64
• Actual Study Completion Date: June 2015
• Actual Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 75 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Australia, Austria, Belgium, France, Germany, Netherlands, New Zealand, Switzerland

Administrative Information

• NCT Number: NCT01541865
• Other Study ID Numbers: CR002-020
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Boston Scientific Corporation
• Study Sponsor: Boston Scientific Corporation
• Collaborators: Not Provided

Investigators

• Principal Investigator: Horst Sievert, M.D.; CardioVascular Center Frankfurt, Germany

• PRS Account: Boston Scientific Corporation
• Verification Date: October 2015