Download Delivery for Pulmonary Arterial Hypertension (PAH)

Key Medtronic Heart Failure Research Trials
Primary Investigator
Robert C. Bourge, MD, University of Alabama at Birmingham
Background
Pulmonary arterial hypertension (PAH) is a rare and devastating disease characterized by high blood pressure in the
arteries leading to the lung that ultimately results in right heart failure and premature death. Current external systems
for parenteral administration of prostanoids (vasodilators) expose patients to risk of infection, catheter complications,
and interference with activities of daily living. A fully implantable system for long-term intravenous infusion of
Remodulin® Injection will be evaluated for safety.
Primary Objective
To demonstrate that the Model 10642 Implantable Intravascular Catheter is safe when used with the Medtronic
SynchroMed® II Implantable Infusion System to deliver Remodulin Injection. The end point is catheter-related
complications per 1,000 patient days.
Methods
• Multicenter, prospective, single arm, non-randomized, open label
• Up to 70 subjects at up to 10 US sites, followed for at least 12 months
• Patients currently treated with the approved intravenous (IV) infusion route of delivery of Remodulin Injection for PAH
• The system includes the Implantable Intravascular Catheter (with sutureless connector) (investigational, Model 10642),
the SynchroMed II Implantable Infusion System (Model 8637), and the N’Vision Clinician® Programmer (Model 8840)
Status
• Currently in follow-up
• Study start: June 2011
• Estimated completion: Fall 2015
Contact
Melissa Thalin, RN, BSN, MBA
Sr. Clinical Research Specialist
Email: [email protected]
Direct Phone: (763) 526-1808
Sponsor
Medtronic, Inc.
Funding
United Therapeutics Corporation
ClinicalTrials.gov ID:
NCT01321073
PROMPT
DEFEAT-HF
Primary Investigators
Angel Leon, MD, Emory University; Gregg W. Stone, MD, Columbia University;
Jesper Hastrup Svendsen, MD, Rigshospitalet
Primary Investigators
Dr. Doug Zipes, MD, Krannert Institute of Cardiology at Indiana University;
Prof. Heinz Theres, MD, Universitatsklinikum Charite
Background
An estimated 785,000 patients will experience a new acute MI and 470,000 will have a recurrent MI in the United
States in 2011, resulting in potential healthcare costs up to $177.5 billion. Within 5 years of an index MI, the risk
of developing heart failure (HF) has been reported to range up to 31%. A novel pacing approach that prevents
paradoxical wall motion may aid in preventing the development of HF following an MI.
Background
Autonomic nervous system dysfunction is a key pathophysiology of heart failure and sudden cardiac death.
Improving autonomic balance to favor the parasympathetic nervous system has been attempted to improve
symptoms and manifestations of HF. Current evidence suggests that thoracic spinal cord stimulation (SCS) may
improve heart failure signs and symptoms by decreasing sympathetic tone and peripheral sympathetic drive,
and decrease sinus rate and AV prolongation.
Primary Objective
To demonstrate the feasibility of post-MI LV or BiV pacing to prevent adverse cardiac remodeling as assessed by
LVEDV at 18 months.
Methods
Primary Objective
To evaluate the reduction in left ventricular end systolic volume index (LVESVi) after 6 months of SCS therapy.
Methods
• Prospective, randomized 3:2 (SCS vs. Control), parallel controlled study
• Prospective, randomized 1:1:1 (BiV pacing vs. LV pacing vs. Control), partially blinded
• Up to 250 subjects at 30 centers (US, Europe, Asia, Middle East), followed to 18 months
• Up to 250 subjects enrolled at 30 centers (North America, Europe), followed to ≥ 12 months
• Subjects with first time MI < 10 days, peak CPK > 3,000 μ/L (or TnT > 10 μ/L)
• Subjects with EF ≤ 35%, NYHA III, QRS ≤ 120 ms, ICD indication
• Experimental intervention includes implantation of a cardiac resynchronization therapy with defibrillator (CRT-D)
device where either BiV or LV pacing will be assigned
• Experimental intervention includes implantation of the PrimeADVANCED SCS neurostimulator and standard
1 x 8 percutaneous lead
Status
• Currently recruiting patients
• Study start: December 2010
• Estimated completion: April 2015
Contact
Marina Ostanniy
Clinical Research Specialist
Email: [email protected]
Direct Phone: (763) 526-9751
Sponsor
Medtronic, Inc.
Funding
Medtronic, Inc.
ClinicalTrials.gov ID:
NCT01213251
Baseline
Baseline/Randomization
Dual Site Pacing
Single Site Pacing
Control
Implant
Post-Implant
Follow-Up
1-Month Follow-Up
3-Month Follow-Up
6-Month Follow-Up
12-Month Follow-Up
18-Month Follow-Up
4-Week
Post-Therapy
Cessation*
Annual
Long-Term
Follow-Up**
* Therapy cessation will only occur if subject develops
a concomitant device indication or has therapy
permanently discontinued.
** Annual long-term follow-ups will only occur in
subjects who choose to continue receiving therapy
after the 18-month follow-up visit.
1-Month Follow-Up
3-Month Follow-Up
Status
• Follow-up phase
• Study start: June 2010
• Estimated completion: July 2014
Contact
Scott A. Sarazin
Clinical Research Specialist
Email: [email protected]
Direct Phone: (763) 526-2817
Enrollment/Baseline
Implant/Randomization
Treatment
Control
Post-Op
Wound Check
Post-Op
Wound Check
1 mo follow-up
1 mo follow-up
3 mo follow-up
3 mo follow-up
6 mo follow-up
6 mo follow-up:
Turn therapy ON
6-Month Follow-Up
12-Month Follow-Up
18-Month Follow-Up
Sponsor
Medtronic, Inc.
7 mo follow-up
Funding
Medtronic, Inc.
ClinicalTrials.gov ID:
NCT01112579
9 mo follow-up
9 mo follow-up
12 mo follow-up
12 mo follow-up
Annual long-term follow-up
or Therapy Cessation Series
Annual long-term follow-up
or Therapy Cessation Series
Notice of Availability
Caution: Investigational devices. Limited by Federal Law (USA) to Investigational Use.
The intended purpose of this poster is to provide physicians with information about the DelIVery for PAH, PRomPT, and Defeat-HF studies in an effort to help make a decision about referring patients for possible participation in these studies. Medtronic, Inc. is sponsoring the DelIVery for PAH, PRomPT, and Defeat-HF studies. Note that the devices used in these studies are not generally available to the public for the indications under investigation in this study.
UC201402346 EN © Medtronic, Inc. 2013. Minneapolis, MN. All Rights Reserved. Printed in USA. 09/2013
Delivery for Pulmonary Arterial Hypertension (PAH)