Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06526195
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-24
Brief Title:
Trial to Evaluate Safety and Effectiveness of Mechanical Circulatory Support in Patients with Advancing Heart Failure
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Trial to Evaluate Safety and Effectiveness of Mechanical Circulatory Support in Patients with Advancing Heart Failure
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TEAM-HF
Brief Summary:
The purpose of TEAM-HF IDE clinical trial is to evaluate safety and effectiveness of the HeartMate 3 LVAS compared to guideline directed medical therapy GDMT in a population of ambulatory advanced heart failure patients who are not dependent on intravenous inotrope
Detailed Description:
Patients with heart failure HF suffer from a high degree of morbidity and mortality Left ventricular assist device LVAD therapy has become the standard of care for the treatment of advanced HF patients who are deemed to be dependent on continuous intravenous inotropes extending life expectancy enhancing overall quality of life and improving functional capacity However use of LVADs in ambulatory non-inotrope dependent advanced HF population is limited Elevated mean pulmonary artery pressure PAP secondary to left ventricular failure has emerged as a potential predictor of increased mortality risk for patients refractory to maximally tolerated guideline directed medical therapy GDMT In these patients left ventricular failure with elevated mean PAP may represent objective criteria to identify advanced HF patients requiring heart replacement therapies such as LVAD
The TEAM-HF IDE trial will enroll approximately 850 subjects with New York Heart Association NYHA Class IIIBIV HF who had a prior heart failure hospitalization and an elevated mean PAP secondary to left ventricular failure Elevated mean PAP will be identified using an implanted PAP monitoring sensor the CardioMEMS PA Sensor All subjects enrolled can have a previously implanted CardioMEMS PA Sensor or if not will be implanted with the CardioMEMS PA Sensor after enrollment The overall objectives of TEAM-HF trial are two-fold 1 To determine whether PAP can objectively identify patients most at risk for worsening HF and therefore most likely to benefit from earlier intervention with LVAD therapy and 2 To determine the benefit of LVAD therapy in non-inotrope advanced HF patients with elevated mean PAP refractory to GDMT
The trial will include approximately 75 global sites and consists of a Randomized Arm and a Single Arm Registry
The TEAM-HF Randomized Arm is a prospective randomized open-label study of the HeartMate 3 HM3 left ventricular assist system LVAS versus continued GDMT in non-inotrope dependent HF patients The objectives of the Randomized Arm are 1 Demonstrate improvement in survival when non-inotrope dependent advanced HF patients with elevated mean PAP are treated with the HM3 compared to being managed on medical therapy alone and 2 To establish an objective disease-state criteria to trigger referral for a HM3 LVAS
The TEAM-HF Single Arm Registry is a prospective single-arm open-label study of non-inotrope dependent HF patients who do not meet a mean PAP threshold after GDMT optimization The objective of the Single Arm Registry is to follow patients with lower mean PAP to evaluate how their HF progresses and if a delayed HM3 implantation would be beneficial for these patients
The TEAM-HF IDE trial will enroll approximately 850 subjects with New York Heart Association NYHA Class IIIBIV HF who had a prior heart failure hospitalization and an elevated mean PAP secondary to left ventricular failure Elevated mean PAP will be identified using an implanted PAP monitoring sensor the CardioMEMS PA Sensor All subjects enrolled can have a previously implanted CardioMEMS PA Sensor or if not will be implanted with the CardioMEMS PA Sensor after enrollment The overall objectives of TEAM-HF trial are two-fold 1 To determine whether PAP can objectively identify patients most at risk for worsening HF and therefore most likely to benefit from earlier intervention with LVAD therapy and 2 To determine the benefit of LVAD therapy in non-inotrope advanced HF patients with elevated mean PAP refractory to GDMT
The trial will include approximately 75 global sites and consists of a Randomized Arm and a Single Arm Registry
The TEAM-HF Randomized Arm is a prospective randomized open-label study of the HeartMate 3 HM3 left ventricular assist system LVAS versus continued GDMT in non-inotrope dependent HF patients The objectives of the Randomized Arm are 1 Demonstrate improvement in survival when non-inotrope dependent advanced HF patients with elevated mean PAP are treated with the HM3 compared to being managed on medical therapy alone and 2 To establish an objective disease-state criteria to trigger referral for a HM3 LVAS
The TEAM-HF Single Arm Registry is a prospective single-arm open-label study of non-inotrope dependent HF patients who do not meet a mean PAP threshold after GDMT optimization The objective of the Single Arm Registry is to follow patients with lower mean PAP to evaluate how their HF progresses and if a delayed HM3 implantation would be beneficial for these patients
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None