Text Size

RENABLATE Feasibility - EC12-02

This study is currently recruiting participants.
Verified December 2012 by Biosense Webster, Inc.
Sponsor:
Information provided by (Responsible Party):
Biosense Webster, Inc.
ClinicalTrials.gov Identifier:
NCT01756300
First received: December 20, 2012
Last updated: December 24, 2012
Last verified: December 2012
History of Changes
  Purpose

The RENABLATE study is a prospective, multi-center, non-randomized feasibility study to evaluate the safety and effectiveness of the investigational Celsius® ThermoCool® RD Multi-electrode Ablation Catheter and integrated ablation system to treat resistant hypertension.


Condition Intervention Phase
Renal Denervation
Hypertension
 Procedure: Renal Sympathetic Denervation
Device: Celsius® ThermoCool® RD Multi-electrode Ablation Catheter
 Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Renal Denervation in Patients With Refractory Hypertension (RENABLATE- EC12-02)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Biosense Webster, Inc.:

Primary Outcome Measures:
  • Renal Denervation Safety [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
    Safety of Renal Denervation in patients with resistant hypertension as measured by Adverse Events [Time Frame: 1, 3, 6 months, annually up to 5 years]


Secondary Outcome Measures:
  • Safety [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    Freedom from adverse renal events through 6 months post-procedure.

  • Reduction [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Reduction of average office based measurements of systolic blood pressure between baseline and 6 months.

  • Ambulatory Blood Pressure Change [ Time Frame: 3, 6, 12 months ] [ Designated as safety issue: No ]
    Change in 24 hour ambulatory blood pressure measurement (ABPM) from baseline to 3, 6 and 12 months.

  • Office Blood Pressure Change [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    Change in office Systolic (SBP) and Diastolic Blood Pressure (DBP) from baseline to 1, 3, 12, 24, 36, 48 and 60 months.

  • Target Blood Pressure [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Incidence of subjects achieving target SBP (SBP <140 mmHg, or < 130 for patients with type 2 diabetes mellitus) at 6 months.

  • Blood Pressure Changes [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Incidence of changes in medical regimen for high blood pressure and low blood pressure through 6 months.


Estimated Enrollment: 30
Study Start Date: December 2012
Estimated Study Completion Date: March 2018
Estimated Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Resistant Hypertension Procedure: Renal Sympathetic Denervation Device: Celsius® ThermoCool® RD Multi-electrode Ablation Catheter

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Subject is ≥ 18 and ≤ 85 years old.
  2. Individual has a systolic blood pressure ≥ 160 mmHg (≥ 150 mmHg for type 2 diabetics) based on an average of 3 office blood pressure readings.
  3. Individual 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.
  4. Individual agrees to have all study procedures performed, and is competent and willing to provide written, informed consent to participate in this study.

Exclusion Criteria:

  1. Subjects with known/diagnosed secondary hypertension.
  2. Subject has 'White Coat' hypertension defined as 24 hour daytime systolic blood pressure <135 mm Hg as evaluated at Baseline visit.
  3. Subject main renal arteries are < 20 mm in length or < 4 mm in diameter.
  4. Subject has multiple main renal arteries in either kidney.
  5. Subject has a history of prior renal artery intervention including balloon angioplasty, stenting or surgery.
  6. Subject had a previous kidney transplant or is a planned recipient of a transplant kidney or is on dialysis.
  7. Subject has an estimated glomerular filtration rate (eGFR) of < 45mL/min/1.73m2, using the MDRD formula.
  8. Subject has type 1 diabetes mellitus.
  9. Subject is under treatment with clonidine, moxonidine, rilmenidin, or oral anti-coagulation.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01756300

Contacts
Contact: Liesbeth Vanderlinden +32 2 7463527

Locations
Belgium
Onze-Lieve-Vrouwziekenhuis Aalst Not yet recruiting
Aalst, Belgium, 9300
Contact: An Roets     +32 (0)3 205 9 305        
Principal Investigator: E. Wyffels, MD            
Czech Republic
Na Homolce Hospital Recruiting
Prague, Czech Republic, 15 030
Contact: Liz Coling     +420 257 271 111        
Principal Investigator: Petr Neuzil, MD            
Denmark
Aarhus University Hospital, Skejby Sygehus Not yet recruiting
Aarhus, Denmark, 8200
Contact: Lars Jorgensen     +45 784 56113        
Principal Investigator: A. Kaltoft, MD            
Sponsors and Collaborators
Biosense Webster, Inc.
  More Information

No publications provided

Responsible Party: Biosense Webster, Inc.
ClinicalTrials.gov Identifier: NCT01756300     History of Changes
Other Study ID Numbers: RENABLATE
Study First Received: December 20, 2012
Last Updated: December 24, 2012
Health Authority: Czech Republic: Ethics Committee
Belgium: Ethics Committee
Denmark: Danish Health and Medicines Authority

Keywords provided by Biosense Webster, Inc.:
Essential Hypertension
Renal Denervation
Vascular Disease
Renal Catheter Ablation
Primary Hypertension

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 19, 2013