RENABLATE Feasibility - EC12-02

This study is currently recruiting participants.
Verified January 2014 by Biosense Webster, Inc.
Sponsor:
Information provided by (Responsible Party):
Biosense Webster, Inc.
ClinicalTrials.gov Identifier:
NCT01756300
First received: December 20, 2012
Last updated: January 29, 2014
Last verified: January 2014
  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: A Prospective, Multi-center, Non Randomized, Feasibility Study of Catheter Based Renal Denervation to Treat Resistant Hypertension (RENABLATE- EC12-02)

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Renal Denervation Safety [ Time Frame: 3 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 3 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 post-procedure.

  • 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 post-procedure.

  • 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, and 36 months post-procedure.

  • 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 II diabetics) 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 post-procedure.

    Incidence of subjects achieving a ≥ 10 mmHg reduction in Systolic Office BP at 1 month, 3 months, 6 months and 12 months post procedure



Estimated Enrollment: 35
Study Start Date: December 2012
Estimated Study Completion Date: December 2016
Primary Completion Date: November 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:   19 Years to 84 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 has aorto-ilio-femoral artery anatomy not suitable for treatment with the investigational Celsius® ThermoCool® RD Multi-electrode Ablation Catheter.
  4. Subject has main renal arteries that are < 20 mm in length or < 4 mm in diameter.
  5. Subject has multiple main renal arteries in either kidney.
  6. Subject has a history of prior renal artery intervention including balloon angioplasty, stenting or surgery.
  7. Subject had a previous kidney transplant or is a planned recipient of a transplant kidney or is on dialysis.
  8. Subject has a past history of unilateral kidney removal or has a solitary functional kidney for any other reason.
  9. Subject has an estimated glomerular filtration rate (eGFR) of < 45mL/min/1.73m2, using the MDRD formula.
  10. Subject has type 1 diabetes mellitus.
  11. 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.
  12. Subject had a significant surgery or cardiovascular intervention in the 6 months period preceding enrollment or is planned to have such a surgery or cardiac intervention in the 6 months period post enrollment.
  13. Subject has hemodynamically significant valvular heart disease for which reduction of blood pressure would be considered hazardous.
  14. Subject is taking systemic steroids or chronic daily NSAIDs.
  15. Subject has a known allergy to Aspirin and/or other procedural drugs or contrast agents which in the investigator's opinion excludes him/her from the study.
  16. Subject has a serious medical condition, which in the opinion of the investigator, may adversely affect the safety and/or effectiveness of the participant or the study (e.g., subjects with active systemic infection, subjects with clinically significant peripheral vascular disease, abdominal aortic aneurysm, bleeding disorders such as thrombocytopenia, hemophilia, or significant anemia).
  17. Women of childbearing potential with a positive pregnancy test during screening OR women who do not agree to remain on birth control until follow-up at 6 months OR lactating women.
  18. Subject has a known, unresolved history of drug use or alcohol dependency, lacks the ability to comprehend or follow instructions, or would be unlikely or unable to comply with study follow-up requirements.
  19. Subject is currently enrolled in another investigational drug or device trial.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01756300

Contacts
Contact: Liesbeth Vanderlinden +32 2 7463527

Locations
Australia, Victoria
Peninsula Heart Centre Recruiting
Frankston, Victoria, Australia, 3199
Contact: Vikki O'Shea    61 3 9789 0088      
Principal Investigator: Gregory Szto, MD         
Belgium
Onze-Lieve-Vrouwziekenhuis Aalst Recruiting
Aalst, Belgium, 9300
Contact: An Roets    +32 (0)3 205 9 305      
Principal Investigator: E. Wyffels, MD         
Ziekenhuis Oost-Limburg Recruiting
Genk, Belgium, 3600
Contact: Nele Peeters    32 89 32 71 93      
Principal Investigator: J. Dens, MD         
Czech Republic
Na Homolce Hospital Recruiting
Prague, Czech Republic, 15 030
Contact: Liz Coling    +420 257 271 111      
Principal Investigator: Petr Neuzil, MD         
Charles University Hospital Recruiting
Prague, Czech Republic, 12808
Contact: Martina Striteska, MD    +420 224 96 2605      
Principal Investigator: Jean-Claude Lubanda, MD         
Denmark
Aarhus University Hospital, Skejby Sygehus Recruiting
Aarhus, Denmark, 8200
Contact: Lars Jorgensen    +45 784 56113      
Principal Investigator: A. Kaltoft, MD         
Germany
Asklepios Kliniken, Proresearch St. Georg Withdrawn
Hamburg, Germany, 20099
Universitatsklinikum des Saarlandes Withdrawn
Homburg, Germany, 66424
Italy
Ospedale Generale Regionale Recruiting
Bari, Italy
Contact: Mario Petruzzi, MD    +39 3474868620      
Principal Investigator: Massimo Grimaldi, 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: January 29, 2014
Health Authority: Czech Republic: SUKL
Belgium: AFMPS
Denmark: Danish Health and Medicines Authority
Germany: BfArM
Italy: AIFA
Australia: Therapeutic Goods Administration (TGA)

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 April 14, 2014