Safety and Efficacy Study of Renal Artery Ablation in Resistant Hypertension Patients (EnligHTN-I)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
St. Jude Medical
ClinicalTrials.gov Identifier:
NCT01438229
First received: September 19, 2011
Last updated: May 24, 2015
Last verified: February 2014
Results First Received: April 17, 2015  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Hypertension
Intervention: Device: St. Jude Medical renal artery ablation system: RF ablation generator (IBI 1500T11.5) and Renal artery ablation catheter (DS3D001, DS3D002)

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Renal Artery Ablation

Catheter-based RF ablation in renal artery

St. Jude Medical renal artery ablation system: RF ablation generator (IBI 1500T11.5) and Renal artery ablation catheter (DS3D001, DS3D002): Catheter-based RF ablation in renal artery


Participant Flow:   Overall Study
    Renal Artery Ablation  
STARTED     47  
Excluded Due to Renal Artery Anatomy     1  
Underwent Procedure     46  
COMPLETED     44  
NOT COMPLETED     3  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Subjects completing renal artery ablation procedure

Reporting Groups
  Description
Renal Artery Ablation

Catheter-based RF ablation in renal artery

St. Jude Medical renal artery ablation system: RF ablation generator (IBI 1500T11.5) and Renal artery ablation catheter (DS3D001, DS3D002): Catheter-based RF ablation in renal artery


Baseline Measures
    Renal Artery Ablation  
Number of Participants  
[units: participants]
  46  
Age  
[units: years]
Mean (Standard Deviation)
  60  (10)  
Gender  
[units: participants]
 
Female     15  
Male     31  
Race/Ethnicity, Customized  
[units: participants]
 
White     45  
Other     1  
Region of Enrollment  
[units: participants]
 
Greece     20  
Australia     26  
Body Mass Index  
[units: kg/m^2]
Mean (Standard Deviation)
  32  (5)  
Coronary Artery Disease  
[units: participants]
 
Yes     9  
No     37  
Hyperlipidemia  
[units: participants]
 
Yes     27  
No     19  
Type II Diabetes Mellitus  
[units: participants]
 
Yes     15  
No     31  
Sleep Apnea  
[units: participants]
 
Yes     14  
No     32  
eGFR  
[units: mL/min/1.73m^2]
Mean (Standard Deviation)
  87  (19)  
Serum Creatinine  
[units: mmol/L]
Mean (Standard Deviation)
  78  (17)  
Cystatin C  
[units: mg/L]
Mean (Standard Deviation)
  1.1  (0.3)  
Urine Albumin-to-Creatinine Ration  
[units: mg/g]
Mean (Standard Deviation)
  167.6  (493)  
Number of Anti-Hypertensive Medications  
[units: medications]
Mean (Standard Deviation)
  4.7  (1.0)  
Office Systolic Blood Pressure  
[units: mmHg]
Mean (Standard Deviation)
  176  (16)  
Office Diastolic Blood Pressure  
[units: mmHg]
Mean (Standard Deviation)
  96  (14)  
Heart Rate  
[units: beats per minute]
Mean (Standard Deviation)
  71  (12)  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Adverse Events   [ Time Frame: 24 months ]

2.  Primary:   Office Systolic Blood Pressure Change   [ Time Frame: Baseline to 6 months ]

3.  Other Pre-specified:   Office Diastolic BP Change   [ Time Frame: Baseline to 6M ]

4.  Other Pre-specified:   Office Systolic BP Change   [ Time Frame: Baseline to 12M ]

5.  Other Pre-specified:   Office Systolic BP Change   [ Time Frame: Baseline to 18 months ]

6.  Other Pre-specified:   Office Systolic BP Change   [ Time Frame: Baseline to 24 months ]

7.  Other Pre-specified:   Office Diastolic BP Change   [ Time Frame: Baseline to 12 months ]

8.  Other Pre-specified:   Office Diastolic BP Change   [ Time Frame: Baseline to 18 months ]

9.  Other Pre-specified:   Office Diastolic BP Change   [ Time Frame: Baseline to 24 months ]

10.  Other Pre-specified:   24hr Ambulatory Systolic BP Change   [ Time Frame: Baseline to 6 months ]

11.  Other Pre-specified:   24hr Ambulatory Systolic BP Change   [ Time Frame: Baseline to 12 months ]

12.  Other Pre-specified:   24hr Ambulatory Systolic BP Change   [ Time Frame: Baseline to 24 months ]

13.  Other Pre-specified:   24hr Ambulatory Diastolic BP Change   [ Time Frame: Baseline to 6 months ]

14.  Other Pre-specified:   24hr Ambulatory Diastolic BP Change   [ Time Frame: Baseline to 12 months ]

15.  Other Pre-specified:   24hr Ambulatory Diastolic BP Change   [ Time Frame: Baseline to 24 months ]

16.  Other Pre-specified:   Urine Albumin to Creatinine Ratio   [ Time Frame: Baseline ]

17.  Other Pre-specified:   Urine Albumin to Creatinine Ratio   [ Time Frame: 6 months ]

18.  Other Pre-specified:   Urine Albumin to Creatinine Ratio   [ Time Frame: 12 months ]

19.  Other Pre-specified:   Urine Albumin to Creatinine Ratio   [ Time Frame: 18 months ]

20.  Other Pre-specified:   Urine Albumin to Creatinine Ratio   [ Time Frame: 24 months ]

21.  Other Pre-specified:   Estimated Glomular Filtration Rate   [ Time Frame: Baseline ]

22.  Other Pre-specified:   Estimated Glomular Filtration Rate   [ Time Frame: 6 months ]

23.  Other Pre-specified:   Estimated Glomular Filtration Rate   [ Time Frame: 12 months ]

24.  Other Pre-specified:   Estimated Glomular Filtration Rate   [ Time Frame: 18 months ]

25.  Other Pre-specified:   Estimated Glomular Filtration Rate   [ Time Frame: 24 months ]

26.  Other Pre-specified:   Cystatin C   [ Time Frame: Baseline ]

27.  Other Pre-specified:   Cystatin C   [ Time Frame: 6 months ]

28.  Other Pre-specified:   Cystatin C   [ Time Frame: 12 months ]

29.  Other Pre-specified:   Cystatin C   [ Time Frame: 18 months ]

30.  Other Pre-specified:   Cystatin C   [ Time Frame: 24 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Steven Madej
Organization: St. Jude Medical
phone: 651-756-2230
e-mail: smadej@sjm.com



Responsible Party: St. Jude Medical
ClinicalTrials.gov Identifier: NCT01438229     History of Changes
Other Study ID Numbers: CI-10-045-ID-HT
Arsenal ( Other Identifier: St Jude Medical )
Study First Received: September 19, 2011
Results First Received: April 17, 2015
Last Updated: May 24, 2015
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration
Greece: National Organization of Medicines