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Trial record 1 of 1 for:    NCT01321073
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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 : April 17, 2020
Sponsor:
Information provided by (Responsible Party):
Medtronic Cardiac Rhythm and Heart Failure

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Pulmonary Arterial Hypertension
Intervention Device: Model 10642 Implantable Intravascular Catheter
Enrollment 64
Recruitment Details  
Pre-assignment Details  
Arm/Group Title DelIVery for Pulmonary Arterial Hypertension Single Arm
Hide Arm/Group Description

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.

Period Title: Overall Study
Started 64
Completed 57
Not Completed 7
Reason Not Completed
Did not attempt implant             4
Death             3
Arm/Group Title DelIVery for Pulmonary Arterial Hypertension Single Arm
Hide Arm/Group Description

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.

Overall Number of Baseline Participants 60
Hide Baseline Analysis Population Description
All patients attempting implant
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 60 participants
50.1  (13.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 60 participants
Female 48
Male 12
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 60 participants
Asian 2
Black or African American 3
Hispanic or Latino 8
White or Caucasian 47
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 60 participants
60
1.Primary Outcome
Title Rate of Catheter-related Complications Per 1000 Patient Days
Hide Description A complication is an adverse event that required an invasive intervention. Complications related to the implanted catheter are counted. In addition, because pneumothoraxes are counted as part of the endpoint.
Time Frame Implant to 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
All days of follow-up for implanted patients
Arm/Group Title DelIVery for Pulmonary Arterial Hypertension Single Arm
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 60
Overall Number of Units Analyzed
Type of Units Analyzed: Patient days
22013
Measure Type: Number
Unit of Measure: complications per 1000 patient-days
0.27
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection DelIVery for Pulmonary Arterial Hypertension Single Arm
Comments The rate of catheter-related complications per 1000 patient-days was compared to a pre-specified value of 2.5 / 1000 days. This was calculated based on published complication rates in PAH that included central venous catheter systemic bloodstream infections (0.43-1.13), site infections (0.26-0.87), and complications from catheter thrombosis, mechanical dysfunction, or catheter dislocation in the general central venous catheter population (0.36-0.51). The sum of the upper rates is 2.5.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method 1-sample exact test for Poisson rate
Comments [Not Specified]
Time Frame Implant to 24 months
Adverse Event Reporting Description An adverse event is any untoward medical occurrence in a subject. Serious Adverse Events include adverse events that result in death, require either inpatient hospitalization or the prolongation of hospitalization, are life-threatening, a persistent or significant disability/incapacity or a congenital anomaly/birth defect. Other important medical events, based upon medical judgment, may also be considered serious if a trial participants' health is at risk and intervention is required.
 
Arm/Group Title Single Arm
Hide Arm/Group Description

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.

All-Cause Mortality
Single Arm
Affected / at Risk (%)
Total   3/60 (5.00%)    
Hide Serious Adverse Events
Single Arm
Affected / at Risk (%) # Events
Total   29/60 (48.33%)    
Blood and lymphatic system disorders   
Anaemia  1  1/60 (1.67%)  1
Autoimmune thrombocytopenia  1  1/60 (1.67%)  1
Cardiac disorders   
Angina unstable  1  1/60 (1.67%)  1
Atrial fibrillation  1  2/60 (3.33%)  2
Atrial flutter  1  1/60 (1.67%)  1
Cardiac failure  1  1/60 (1.67%)  1
Pericardial effusion  1  1/60 (1.67%)  1
Right ventricular failure  1  1/60 (1.67%)  1
Gastrointestinal disorders   
Gastrointestinal haemorrhage  1  1/60 (1.67%)  1
Vomiting  1  1/60 (1.67%)  1
General disorders   
Device damage  1  1/60 (1.67%)  1
Device dislocation  1  2/60 (3.33%)  3
Immediate post-injection reaction  1  3/60 (5.00%)  3
Implant site effusion  1  1/60 (1.67%)  1
Injection site reaction  1  1/60 (1.67%)  1
Hepatobiliary disorders   
Cholecystitis acute  1  1/60 (1.67%)  1
Infections and infestations   
Implant site infection  1  1/60 (1.67%)  1
Lobar pneumonia  1  1/60 (1.67%)  1
Lyme disease  1  1/60 (1.67%)  1
Pneumonia  1  1/60 (1.67%)  2
Pneumonia legionella  1  1/60 (1.67%)  1
Rhinovirus infection  1  1/60 (1.67%)  1
Septic shock  1  1/60 (1.67%)  1
Urinary tract infection  1  1/60 (1.67%)  1
Injury, poisoning and procedural complications   
Postoperative fever  1  1/60 (1.67%)  1
Rib fracture  1  1/60 (1.67%)  1
Metabolism and nutrition disorders   
Fluid overload  1  2/60 (3.33%)  2
Gout  1  1/60 (1.67%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Adenocarcinoma of colon  1  1/60 (1.67%)  1
Lung adenocarcinoma  1  1/60 (1.67%)  1
Nervous system disorders   
Syncope  1  1/60 (1.67%)  1
Renal and urinary disorders   
Renal failure  1  1/60 (1.67%)  1
Renal failure chronic  1  1/60 (1.67%)  1
Reproductive system and breast disorders   
Endometriosis  1  1/60 (1.67%)  1
Respiratory, thoracic and mediastinal disorders   
Bronchospasm  1  1/60 (1.67%)  1
Dyspnoea  1  1/60 (1.67%)  1
Dyspnoea exertional  1  1/60 (1.67%)  1
Epistaxis  1  1/60 (1.67%)  1
Pleural effusion  1  1/60 (1.67%)  1
Pneumothorax  1  2/60 (3.33%)  2
Pulmonary embolism  1  1/60 (1.67%)  1
Vascular disorders   
Deep vein thrombosis  1  1/60 (1.67%)  1
Hypotension  1  1/60 (1.67%)  2
Venous stenosis  1  1/60 (1.67%)  1
1
Term from vocabulary, MedDRA (16.0)
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Single Arm
Affected / at Risk (%) # Events
Total   57/60 (95.00%)    
Gastrointestinal disorders   
Abdominal pain  1  6/60 (10.00%)  6
Constipation  1  4/60 (6.67%)  4
Diarrhoea  1  5/60 (8.33%)  5
Nausea  1  11/60 (18.33%)  11
Vomiting  1  4/60 (6.67%)  4
General disorders   
Fatigue  1  6/60 (10.00%)  6
Implant site bruising  1  10/60 (16.67%)  10
Implant site pain  1  51/60 (85.00%)  54
Injection site pain  1  4/60 (6.67%)  4
Injection site reaction  1  9/60 (15.00%)  10
Infections and infestations   
Nasopharyngitis  1  4/60 (6.67%)  4
Upper respiratory tract infection  1  17/60 (28.33%)  21
Injury, poisoning and procedural complications   
Procedural vomiting  1  4/60 (6.67%)  4
Metabolism and nutrition disorders   
Hypokalaemia  1  4/60 (6.67%)  4
Musculoskeletal and connective tissue disorders   
Back pain  1  6/60 (10.00%)  6
Musculoskeletal pain  1  4/60 (6.67%)  4
Pain in extremity  1  7/60 (11.67%)  7
Nervous system disorders   
Dizziness  1  7/60 (11.67%)  7
Headache  1  8/60 (13.33%)  10
Psychiatric disorders   
Insomnia  1  5/60 (8.33%)  5
Respiratory, thoracic and mediastinal disorders   
Dyspnoea  1  10/60 (16.67%)  16
Dyspnoea exertional  1  5/60 (8.33%)  5
Pulmonary arterial hypertension  1  8/60 (13.33%)  9
Vascular disorders   
Flushing  1  5/60 (8.33%)  5
Hypotension  1  9/60 (15.00%)  9
1
Term from vocabulary, MedDRA (16.0)
Indicates events were collected by systematic assessment
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.
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Robert Bourge, M.D., Professor of Medicine, Radiology, and Surgery
Organization: The University of Alabama at Birmingham
Phone: (205)934-7400
EMail: bbourge@uab.edu
Layout table for additonal information
Responsible Party: Medtronic Cardiac Rhythm and Heart Failure
ClinicalTrials.gov Identifier: NCT01321073    
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: April 17, 2020