Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Help guide our efforts to modernize ClinicalTrials.gov.
Send us your comments by March 14, 2020.

EnligHTN IV Trial - Multicenter Sham-controlled RCT of Renal Denervation for Hypertension (EnligHTN-IV)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01903187
Recruitment Status : Terminated (There were no safety or effectiveness concerns. There were concerns about completing enrollment due to a competitive device's potential approval.)
First Posted : July 19, 2013
Results First Posted : March 17, 2016
Last Update Posted : February 15, 2019
Sponsor:
Information provided by (Responsible Party):
Abbott Medical Devices

Tracking Information
First Submitted Date  ICMJE July 9, 2013
First Posted Date  ICMJE July 19, 2013
Results First Submitted Date  ICMJE October 15, 2015
Results First Posted Date  ICMJE March 17, 2016
Last Update Posted Date February 15, 2019
Study Start Date  ICMJE October 2013
Actual Primary Completion Date June 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 15, 2016)
  • The Primary Safety Endpoint Will be the Proportion of Subjects Who Experience Any Major Adverse Event (MAE) as Adjudicated by the Clinical Event Committee (CEC). [ Time Frame: 6 months post randomization ]
    The study enrollment was terminated early by the sponsor. This was not related to any safety issue. At the time enrollment was halted, only 2 treatment group randomizations had occurred.
  • The Primary Effectiveness Endpoint is the Reduction of Office Systolic Blood Pressure (OSBP) at Six (6) Months Post Randomization Compared to Baseline Between Groups [ Time Frame: 6 months post randomization ]
Original Primary Outcome Measures  ICMJE
 (submitted: July 16, 2013)
  • The Primary Safety Endpoint Will be the Proportion of Subjects Who Experience Any Major Adverse Event (MAE) as Adjudicated by the Clinical Event Committee (CEC). [ Time Frame: 6 months post randomization ]
  • The Primary Effectiveness Endpoint is the Reduction of Office Systolic Blood Pressure (OSBP) at Six (6) Months Post Randomization Compared to Baseline Between Groups [ Time Frame: 6 months post randomization ]
Change History Complete list of historical versions of study NCT01903187 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 15, 2016)
  • Device or Procedure Related Adverse Events by Severity Post Randomization Through Six (6) Months [ Time Frame: 6 months post randomization ]
    The study enrollment was terminated early by the sponsor. This was not related to any safety issue. At the time enrollment was halted, only 2 treatment group randomizations had occurred, and sham group subjects were exited after their 1 month follow up visit. This was not enough to conduct the analysis.
  • The Number of Subjects That Experience Each Type of MAE [ Time Frame: 6 months post randomization ]
    The study enrollment was terminated early by the sponsor. This was not related to any safety issue. At the time enrollment was halted, only 2 treatment group randomizations had occurred, and sham group subjects were exited after their 1 month follow up visit. This was not enough to conduct the analysis.
  • Incidence of Achieving ≥ 10 mmHg, ≥ 15 mmHg, and ≥20 mmHg Reductions in OSBP [ Time Frame: 6 months post randomization, and all follow-up timepoints ]
    The study enrollment was terminated early by the sponsor. This was not related to any safety issue. At the time enrollment was halted, only 2 treatment group randomizations had occurred, and sham group subjects were exited after their 1 month follow up visit. This was not enough to conduct the analysis.
  • Reduction in Ambulatory Blood Pressure (ABP) Parameters [ Time Frame: baseline, 6 months post randomization, and all follow-up timepoints ]
    The study enrollment was terminated early by the sponsor. This was not related to any safety issue. At the time enrollment was halted, only 2 treatment group randomizations had occurred, and sham group subjects were exited after their 1 month follow up visit. This was not enough to conduct the analysis.
Original Secondary Outcome Measures  ICMJE
 (submitted: July 16, 2013)
  • Device or Procedure Related Adverse Events by Severity Post Randomization Through Six (6) Months [ Time Frame: 6 months post randomization ]
  • The Number of Subjects That Experience Each Type of MAE [ Time Frame: 6 months post randomization ]
  • Incidence of Achieving ≥ 10 mmHg, ≥ 15 mmHg, and ≥20 mmHg Reductions in OSBP [ Time Frame: 6 months post randomization, and all follow-up timepoints ]
  • Reduction in Ambulatory Blood Pressure (ABP) Parameters [ Time Frame: baseline, 6 months post randomization, and all follow-up timepoints ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE EnligHTN IV Trial - Multicenter Sham-controlled RCT of Renal Denervation for Hypertension
Official Title  ICMJE Multi-center, Randomized, Single-blind, Sham Controlled Clinical Investigation of Renal Denervation for Uncontrolled Hypertension
Brief Summary The purpose of the EnligHTN IV clinical investigation is to demonstrate the safety and effectiveness of the EnligHTN™ Renal Denervation System in the treatment of subjects with drug-resistant uncontrolled hypertension.
Detailed Description

The study enrollment was terminated early by the sponsor. This was not related to any safety issue. At the time enrollment was halted, only 2 treatment group randomizations had occurred, and sham group subjects were exited after their 1 month follow up visit.

Subject randomized to the treatment group will be followed up for three years post procedure.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE Hypertension
Intervention  ICMJE
  • Device: EnligHTN Renal Denervation
    Renal artery angiogram plus bilateral renal denervation with the EnligHTN renal denervation system
  • Procedure: Sham
    Renal artery angiogram
Study Arms  ICMJE
  • Experimental: Renal Denervation
    Renal artery ablation with the EnligHTN™ Renal Denervation System.
    Intervention: Device: EnligHTN Renal Denervation
  • Active Comparator: Sham procedure
    Sham procedure
    Intervention: Procedure: Sham
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: March 15, 2016)
4
Original Estimated Enrollment  ICMJE
 (submitted: July 16, 2013)
590
Actual Study Completion Date  ICMJE November 2016
Actual Primary Completion Date June 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Subject is ≥18 years of age and ≤ 80 years of age at time of informed consent for participation in the clinical investigation
  • Subject must be able and willing to provide written informed consent
  • Subject must be able and willing to comply with the required follow-up schedule
  • Subject has an office Systolic Blood Pressure ≥ 160 mmHg based on an average of 3 Blood Pressure readings at the confirmatory visit (except for subjects with Diabetes Mellitus Type II who must demonstrate an office Systolic Blood Pressure of ≥ 150 mmHg)
  • Subject has a daytime mean Systolic 24-hour Ambulatory Blood Pressure value of ≥ 140 mmHg as measured during the two week screening period and confirmed at the confirmatory visit
  • Subject is taking ≥ 3 antihypertensive medications concurrently at full tolerated doses (this must include one diuretic) or subject is taking a diuretic and has a documented intolerance to at least two (2) out of the three (3) remaining major classes of anti-hypertensives (ACE / ARB, Calcium Channel Blockers, Beta blockers and is unable to take 3 anti-hypertensive drugs)

    o Intolerance is defined as an absolute contraindication to an anti-hypertensive medication according to the approved labeling or an inability to take an anti-hypertensive medication as prescribed due to an adverse drug effect including an immune mediated response or interaction with other medications.

  • Subjects must be on a stable antihypertensive medication regimen for a minimum of 2 weeks prior to completing the initial screening visit and the medication regimen must remain unchanged during the 2 week screening period following signing consent. Subject must be assessed at the confirmatory visit with no expected changes for at least six (6) months

Exclusion Criteria:

  • Subject has had a previous renal denervation attempt
  • Subject has known cause of secondary hypertension other than sleep apnea
  • Subjects with significant renovascular abnormalities such as renal artery stenosis >30%, previous renal stenting or angioplasty, renal artery occlusion, renal vein thrombosis, renal aneurysm or renal atheroembolism
  • Subject has had a myocardial infarction, unstable angina pectoris, or cerebrovascular accident < 180 days prior to enrollment
  • Subject has hemodynamically significant valvular heart disease as determined by a Study Investigator
  • Subject is expected to have any cardiovascular intervention within 180 days of enrollment
  • Subject has blood clotting abnormalities such as thrombocytopenia, hemophilia, or significant anemia
  • Subject life expectancy is < 12 months, as determined by a Study Investigator
  • Subject is participating in another Clinical Investigation (IND or IDE)
  • Subject is pregnant, nursing, or of childbearing potential and is not using adequate contraceptive methods
  • Subject has active systemic infection as determined by a Study Investigator
  • Subject has main renal arteries with diameter(s) < 4 mm in diameter or < 20 mm in length or multiple renal arteries where the main renal arteries supply <75% of the kidney
  • Subject has eGFR < 45 mL/min per 1.73 m2 using the MDRD formula
  • Subject has evidence of significant AAA defined as an aneurysm size of ≥5.0 cm in width and/or involving the renal arteries, and/or requiring surgical or percutaneous intervention within 6 months of enrollment.
  • Subject has had >1 in-patient hospitalization for a hypertensive crisis within 12 months
  • Subject has a condition which would interfere with the accurate interpretation of the study endpoints
  • Any condition that would prohibit or interfere with the ability to obtain accurate Blood Pressure measurements using the CIP specific automatic Blood Pressure monitor
  • Subject has Systolic Blood Pressure values which are greater than 20mmHg apart after six (6) measurements as assessed at the confirmatory visit
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01903187
Other Study ID Numbers  ICMJE 1204
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Abbott Medical Devices
Study Sponsor  ICMJE Abbott Medical Devices
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: William B White, MD UConn Health
Study Chair: William A Gray, MD Columbia University
PRS Account Abbott Medical Devices
Verification Date January 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP