RENABLATE Feasibility Study CS156 (EC12-02) Study of Catheter Based Renal Denervation to Treat Resistant Hypertension

NCT ID: NCT01756300

Last Updated: 2025-02-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 35 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-12-31
• Study Completion Date: 2015-04-30

Brief Summary

The RENABLATE feasibility study is a prospective, multi-center, non-randomized feasibility study to evaluate the safety and effectiveness of the investigational multi-electrode ablation catheter and integrated ablation system to treat resistant hypertension.

Detailed Description

The RENABLATE feasibility study CS156 (EC12-02) is a prospective, multi-center, non-randomized feasibility study to evaluate the safety and effectiveness of renal artery sympathetic denervation using the investigational Celsius® ThermoCool® Renal Denervation (RD) Multi-electrode Ablation Catheter and integrated ablation system to treat resistant hypertension.

Conditions

Hypertension, Renal

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Resistant Hypertension

The catheter-based (device: Celsius® ThermoCool® RD) renal denervation will serve to treat resistant hypertension.

Group Type: EXPERIMENTAL

Celsius® ThermoCool® RD

Intervention Type: DEVICE

The investigational device is designed to transmit radiofrequency (RF) current to the electrodes for ablation purposes, specifically for the treatment of resistant hypertension by renal denervation.

Interventions

Celsius® ThermoCool® RD

The investigational device is designed to transmit radiofrequency (RF) current to the electrodes for ablation purposes, specifically for the treatment of resistant hypertension by renal denervation.

Intervention Type: DEVICE

Other Intervention Names

Multi-electrode Ablation Catheter

Eligibility 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.

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 84 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Biosense Webster, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

RENABLATE

Identifier Type: -

Identifier Source: org_study_id