RENABLATE Feasibility - EC12-02

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Biosense Webster, Inc.
ClinicalTrials.gov Identifier:
NCT01756300
First received: December 20, 2012
Last updated: July 27, 2015
Last verified: July 2015
Results First Received: July 27, 2015  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Renal Denervation
Hypertension
Interventions: Procedure: Renal Sympathetic Denervation
Device: Celsius® ThermoCool® RD Multi-electrode Ablation Catheter

  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
The study enrollment took approximately 11 months, began in December 2, 2012 and completed on November 4, 2013. A total of 68 subjects were consented and 35 started the renal denervation with the investigational ablation catheter.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
After signing the inform of consent, subjects were evaluated on inclusion/exclusion criteria, anatomic eligibility, compliant with completing the subject diary. Thirty-three subjects failed and never underwent insertion of the study ablation catheter.

Reporting Groups
  Description
Renal Sympathetic Denervation Subjects enrolled in this study underwent the renal sympathetic denervation procedure to treat resistant hypertension. The procedure used the investigational Celsius® ThermoCool® Renal Denervation Multi-electrode Ablation Catheter in subjects with severe resistant hypertension.

Participant Flow:   Overall Study
    Renal Sympathetic Denervation  
STARTED     35 [1]
COMPLETED     33 [2]
NOT COMPLETED     2  
Death                 1  
Withdrawal by Subject                 1  
[1] Subjects underwent renal denervation treatment with the study catheter.
[2] Subjects with follow up available at 12 months



  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.
All treated subjects who underwent the renal sympathetic denervation procedure.

Reporting Groups
  Description
Renal Sympathetic Denervation Subjects enrolled in this study underwent the renal sympathetic denervation procedure to treat resistant hypertension. The procedure used the investigational Celsius® ThermoCool® Renal Denervation Multi-electrode Ablation Catheter in subjects with resistant hypertension.

Baseline Measures
    Renal Sympathetic Denervation  
Number of Participants  
[units: participants]
  35  
Age  
[units: years]
Mean (Standard Deviation)
  62.5  (9.5)  
Gender  
[units: participants]
 
Female     12  
Male     23  
Race/Ethnicity, Customized  
[units: participants]
 
African Descent     0  
Not African Descent     35  
Region of Enrollment  
[units: participants]
 
Czech Republic     12  
Belgium     5  
Denmark     1  
Australia     15  
Italy     2  



  Outcome Measures
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1.  Primary:   The Incidence of Major Cardiovascular and/or Renal Adverse Events Related to the Renal Denervation Procedure That Occurred Within 30 Days Post-procedure.   [ Time Frame: 30 days post-procedure ]

2.  Secondary:   Subjects Experienced Any Adverse Cardiovascular and Renal Events Through 12 Months Post-procedure   [ Time Frame: 12 months post-procedure ]

3.  Secondary:   Change in Office Systolic Blood Pressure and Diastolic Blood Pressure From Baseline to 1 ,3, 6 and 12 Months Post Procedure   [ Time Frame: From baseline to 12 months post-procedure ]

4.  Secondary:   Change in 24-hour Ambulatory Blood Pressure Monitoring (ABPM) Systolic Blood Pressure and Diastolic Blood Pressure From Baseline to 3, 6 and 12 Months Post Procedure   [ Time Frame: From baseline to 12 months post-procedure ]

5.  Secondary:   Incidence of Subjects Achieving Target Systolic Blood Pressure at 1, 3, 6, and 12 Month Post-procedure   [ Time Frame: 12 months post-procedure ]

6.  Secondary:   Incidence of Subjects Achieving at Least 10 mmHg Systolic Blood Pressure Reduction From Baseline at 1, 3, 6, and 12 Month Post-procedure   [ Time Frame: 12 months post-procedure ]


  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 less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
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.


Results Point of Contact:  
Name/Title: Liesbeth Vanderlinden, Manager Clinical Research
Organization: Biosense Webster, EMEA
phone: +32(0)2 7463527
e-mail: lvanderl@its.JNJ.com


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
Results First Received: July 27, 2015
Last Updated: July 27, 2015
Health Authority: Czech Republic: SUKL
Belgium: AFMPS
Denmark: Danish Health and Medicines Authority
Germany: BfArM
Italy: AIFA
Australia: Therapeutic Goods Administration (TGA)