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DelIVery for Pulmonary Arterial Hypertension (PAH) (DelIVery)

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: NCT01321073
Recruitment Status : Active, not recruiting
First Posted : March 23, 2011
Results First Posted : May 4, 2018
Last Update Posted : May 4, 2018
Sponsor:
Information provided by (Responsible Party):
Medtronic Cardiac Rhythm and Heart Failure

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Pulmonary Arterial Hypertension
Intervention: Device: Model 10642 Implantable Intravascular Catheter

  Participant Flow

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
DelIVery for Pulmonary Arterial Hypertension Single Arm

All subjects were enrolled for implantation of the Model 10642 Implantable Intravascular Catheter used in combination with the SynchroMed II Implantable Infusion System (Model 8637) to deliver Remodulin Injection.

Model 10642 Implantable Intravascular Catheter: This clinical study consists of the Model 10642 Implantable Intravascular Catheter used in combination with the SynchroMed II Implantable Infusion System (Model 8637) to deliver Remodulin Injection. This study will focus on the safety of delivery of Remodulin Injection in the treatment of patients with PAH who meet the approved Remodulin Injection indication, using the approved formulation, and approved intravenous route of administration.


Participant Flow:   Overall Study
    DelIVery for Pulmonary Arterial Hypertension Single Arm
STARTED   64 
COMPLETED   57 
NOT COMPLETED   7 
Did not attempt implant                4 
Death                3 



  Baseline Characteristics

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 patients attempting implant

Reporting Groups
  Description
DelIVery for Pulmonary Arterial Hypertension Single Arm

All subjects were enrolled for implantation of the Model 10642 Implantable Intravascular Catheter used in combination with the SynchroMed II Implantable Infusion System (Model 8637) to deliver Remodulin Injection.

Model 10642 Implantable Intravascular Catheter: This clinical study consists of the Model 10642 Implantable Intravascular Catheter used in combination with the SynchroMed II Implantable Infusion System (Model 8637) to deliver Remodulin Injection. This study will focus on the safety of delivery of Remodulin Injection in the treatment of patients with PAH who meet the approved Remodulin Injection indication, using the approved formulation, and approved intravenous route of administration.


Baseline Measures
   DelIVery for Pulmonary Arterial Hypertension Single Arm 
Overall Participants Analyzed 
[Units: Participants]
 60 
Age 
[Units: Years]
Mean (Standard Deviation)
 50.1  (13.5) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female   48 
Male   12 
Race/Ethnicity, Customized 
[Units: Participants]
Count of Participants
 
Asian   2 
Black or African American   3 
Hispanic or Latino   8 
White or Caucasian   47 
Region of Enrollment 
[Units: Participants]
Count of Participants
 
United States   60 


  Outcome Measures

1.  Primary:   Rate of Catheter-related Complications Per 1000 Patient Days   [ Time Frame: Implant to 2 years ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

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
Results are through June, 2013 when 22,000 patient days of implant had been accumulated. This was the pre-specified primary analysis time for the study. The study continued past this point.


  More Information

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: Robert Bourge, M.D., Professor of Medicine, Radiology, and Surgery
Organization: The University of Alabama at Birmingham
phone: (205)934-7400
e-mail: bbourge@uab.edu


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Medtronic Cardiac Rhythm and Heart Failure
ClinicalTrials.gov Identifier: NCT01321073     History of Changes
Other Study ID Numbers: PAH-D
First Submitted: March 21, 2011
First Posted: March 23, 2011
Results First Submitted: January 16, 2018
Results First Posted: May 4, 2018
Last Update Posted: May 4, 2018