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RENABLATE-II Feasibility Study of Catheter Based Renal Denervation to Treat Resistant Hypertension - 157 (RENABLATE-II)

Primary Purpose

Hypertension, Renal

Status
Completed
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
Celsius® ThermoCool® Renal Denervation
Sponsored by
Biosense Webster, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypertension, Renal focused on measuring Renal Sympathetic Denervation

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Subject has a systolic blood pressure ≥ 140 mmHg based on an average of 3 office blood pressure readings measured according to the BP guidelines.
  2. Subject is adhering to a stable drug regimen of at least 3 different classes of anti-hypertensive medications, including a diuretic (with no changes for a minimum of 2 weeks prior to enrollment) at optimal dose and is expected to be maintained for at least 6 months.
  3. Subject is > 18 and < 85 years of age.
  4. Subject agrees to have all study procedures performed, and is competent and willing to provide written, informed consent to participate in this study.

Key Exclusion Criteria:

  1. A secondary cause of hypertension, e.g. "white coat" hypertension (assessed by 24 h ABPM at physician's discretion), primary aldosteronism, pheochromocytoma, renal artery stenosis, drug induced-hypertension, Adult Polycystic kidney Disease, renal cell carcinoma, pyelonephritis, glomerulonephritis, coarctation of the aorta, acromegaly, Cushing's Syndrome, Conn's (primary hyperaldosteronism), polyarteritis nodosum, systemic sclerosis, parenchymal kidney disease, obstructive sleep apnoea based on a workup performed within the 12 months preceding enrollment.
  2. Subject has aorto-ilio-femoral artery anatomy not suitable for treatment with the investigational device(s).
  3. Subject has main renal arteries that are < 20 mm in length or < 4 mm in diameter.
  4. Subject has a prior history of any renal artery intervention including but not limited to balloon angioplasty, stenting, renal denervation or surgery.
  5. Subject has an estimated glomerular filtration rate (eGFR) of < 45mL/min/1.73m2, using the MDRD formula.
  6. Subject has type 1 diabetes mellitus.
  7. Subject has history of Myocardial Infarction, unstable angina pectoris, or a cerebrovascular accident in the 6 months period prior to enrolment, or documented widespread atherosclerosis, intravascular thrombosis or unstable plaques.
  8. Subject has hemodynamically significant valvular heart disease for which reduction of blood pressure would be considered hazardous.

Sites / Locations

  • Charles University Hospital
  • Na Homolce Hospital
  • Ospedale Generale Regionale
  • Mercy Angiography
  • Hospital Universitari Clinic de Barcelona

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Resistant Hypertension

Arm Description

The Celsius® ThermoCool® Renal Denervation catheter will serve to treat resistant hypertension.

Outcomes

Primary Outcome Measures

Incidence of Major Adverse Events That Occurred Within 30 Days Post-procedure.
Major adverse events include Acute myocardial infarction; Death from progressive heart failure, death from aortic or peripheral artery disease, from renal failure and sudden cardiac death; New-onset heart failure; Stroke; Aortic or lower limb revascularization procedure; Lower limb amputation; Beginning dialysis; Hospital admission for hypertensive emergency unrelated to non-adherence or non-persistence with drugs at each follow up visit; Hospitalization for atrial fibrillation.

Secondary Outcome Measures

Incidence of Adverse Cardiovascular and Renal Events Within the 12 Month Follow-up Visit
These adverse events include renal artery stenosis (≥60% diameter reduction confirmed by MRI or renal angiography); peri-procedural renal artery dissection or perforation requiring intervention, serious arterial access site related complications requiring intervention or prolonging hospitalization; ≥25% reduction between baseline and 12 months in renal function measured by the estimated Glomerular Filtration Rate (eGFR), as well as composite of major adverse cardiovascular and/or renal events.
Mean Change in Office Systolic Blood Pressure and Diastolic Blood Pressure From Baseline to 1 ,3, 6 and 12 Months Post Procedure
Office systolic blood pressure (SBP) and diastolic blood pressure (DBP) measures were summarized to assess the reduction in blood pressure from baseline visit to post baseline at 1, 3, 6, and 12 months. Negative values for change represent reductions.
Incidence of Subjects Achieving Target Systolic Blood Pressure (SBP) at 1, 3, 6 and 12 Months Post Procedure
The pre-specified target SBP is defined as SBP <130 mmHg. This endpoint is defined at each of 1, 3, 6 and 12 months post procedure.
Incidence of Subjects Achieving a ≥ 10 mmHg Reduction in Systolic Blood Pressure (SBP) at 1, 3, 6 and 12 Months Post Procedure
Incidence of subjects achieving a 10 mmHg or more reduction in Systolic Blood Pressure (SBP) at 1, 3, 6 and 12 months post procedure.

Full Information

First Posted
March 21, 2014
Last Updated
October 30, 2015
Sponsor
Biosense Webster, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT02095691
Brief Title
RENABLATE-II Feasibility Study of Catheter Based Renal Denervation to Treat Resistant Hypertension - 157
Acronym
RENABLATE-II
Official Title
A Prospective, Multi-center, Non-Randomized, Feasibility Study of Catheter Based Renal Denervation to Treat Resistant Hypertension (RENABLATE-II - 157)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2015
Overall Recruitment Status
Completed
Study Start Date
October 2013 (undefined)
Primary Completion Date
March 2014 (Actual)
Study Completion Date
April 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Biosense Webster, Inc.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This is a prospective, multi-center, non-randomized, feasibility study to assess the safety and effectiveness of renal artery sympathetic denervation using the investigational devices in subjects with resistant hypertension.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension, Renal
Keywords
Renal Sympathetic Denervation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
19 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Resistant Hypertension
Arm Type
Experimental
Arm Description
The Celsius® ThermoCool® Renal Denervation catheter will serve to treat resistant hypertension.
Intervention Type
Device
Intervention Name(s)
Celsius® ThermoCool® Renal Denervation
Other Intervention Name(s)
Multi-electrode Ablation Catheter
Intervention Description
The investigational device is indicated for the treatment of resistant hypertension by renal denervation.
Primary Outcome Measure Information:
Title
Incidence of Major Adverse Events That Occurred Within 30 Days Post-procedure.
Description
Major adverse events include Acute myocardial infarction; Death from progressive heart failure, death from aortic or peripheral artery disease, from renal failure and sudden cardiac death; New-onset heart failure; Stroke; Aortic or lower limb revascularization procedure; Lower limb amputation; Beginning dialysis; Hospital admission for hypertensive emergency unrelated to non-adherence or non-persistence with drugs at each follow up visit; Hospitalization for atrial fibrillation.
Time Frame
30 days post-procedure
Secondary Outcome Measure Information:
Title
Incidence of Adverse Cardiovascular and Renal Events Within the 12 Month Follow-up Visit
Description
These adverse events include renal artery stenosis (≥60% diameter reduction confirmed by MRI or renal angiography); peri-procedural renal artery dissection or perforation requiring intervention, serious arterial access site related complications requiring intervention or prolonging hospitalization; ≥25% reduction between baseline and 12 months in renal function measured by the estimated Glomerular Filtration Rate (eGFR), as well as composite of major adverse cardiovascular and/or renal events.
Time Frame
12 months post-procedure
Title
Mean Change in Office Systolic Blood Pressure and Diastolic Blood Pressure From Baseline to 1 ,3, 6 and 12 Months Post Procedure
Description
Office systolic blood pressure (SBP) and diastolic blood pressure (DBP) measures were summarized to assess the reduction in blood pressure from baseline visit to post baseline at 1, 3, 6, and 12 months. Negative values for change represent reductions.
Time Frame
12 months post-procedure
Title
Incidence of Subjects Achieving Target Systolic Blood Pressure (SBP) at 1, 3, 6 and 12 Months Post Procedure
Description
The pre-specified target SBP is defined as SBP <130 mmHg. This endpoint is defined at each of 1, 3, 6 and 12 months post procedure.
Time Frame
12 months post-procedure
Title
Incidence of Subjects Achieving a ≥ 10 mmHg Reduction in Systolic Blood Pressure (SBP) at 1, 3, 6 and 12 Months Post Procedure
Description
Incidence of subjects achieving a 10 mmHg or more reduction in Systolic Blood Pressure (SBP) at 1, 3, 6 and 12 months post procedure.
Time Frame
12 months post-procedure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Subject has a systolic blood pressure ≥ 140 mmHg based on an average of 3 office blood pressure readings measured according to the BP guidelines. Subject is adhering to a stable drug regimen of at least 3 different classes of anti-hypertensive medications, including a diuretic (with no changes for a minimum of 2 weeks prior to enrollment) at optimal dose and is expected to be maintained for at least 6 months. Subject is > 18 and < 85 years of age. Subject agrees to have all study procedures performed, and is competent and willing to provide written, informed consent to participate in this study. Key Exclusion Criteria: A secondary cause of hypertension, e.g. "white coat" hypertension (assessed by 24 h ABPM at physician's discretion), primary aldosteronism, pheochromocytoma, renal artery stenosis, drug induced-hypertension, Adult Polycystic kidney Disease, renal cell carcinoma, pyelonephritis, glomerulonephritis, coarctation of the aorta, acromegaly, Cushing's Syndrome, Conn's (primary hyperaldosteronism), polyarteritis nodosum, systemic sclerosis, parenchymal kidney disease, obstructive sleep apnoea based on a workup performed within the 12 months preceding enrollment. Subject has aorto-ilio-femoral artery anatomy not suitable for treatment with the investigational device(s). Subject has main renal arteries that are < 20 mm in length or < 4 mm in diameter. Subject has a prior history of any renal artery intervention including but not limited to balloon angioplasty, stenting, renal denervation or surgery. Subject has an estimated glomerular filtration rate (eGFR) of < 45mL/min/1.73m2, using the MDRD formula. Subject has type 1 diabetes mellitus. Subject has history of Myocardial Infarction, unstable angina pectoris, or a cerebrovascular accident in the 6 months period prior to enrolment, or documented widespread atherosclerosis, intravascular thrombosis or unstable plaques. Subject has hemodynamically significant valvular heart disease for which reduction of blood pressure would be considered hazardous.
Facility Information:
Facility Name
Charles University Hospital
City
Prague
ZIP/Postal Code
12808
Country
Czech Republic
Facility Name
Na Homolce Hospital
City
Prague
ZIP/Postal Code
15 030
Country
Czech Republic
Facility Name
Ospedale Generale Regionale
City
Bari
Country
Italy
Facility Name
Mercy Angiography
City
Epsom
State/Province
Auckland
Country
New Zealand
Facility Name
Hospital Universitari Clinic de Barcelona
City
Barcelona
Country
Spain

12. IPD Sharing Statement

Learn more about this trial

RENABLATE-II Feasibility Study of Catheter Based Renal Denervation to Treat Resistant Hypertension - 157

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