NCT02468778

SHIELD II Clinical Investigation

Supporting Patients Undergoing HIgh-Risk PCI Using a High-Flow PErcutaneous Left Ventricular Support Device (SHIELD II)

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 54 (actual)
• Sponsor: Abbott Medical Devices · Industry
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

Summary

The HeartMate PHP System is a temporary (\<6 hours) ventricular assist device indicated for use during high-risk percutaneous coronary interventions (PCI) performed electively or urgently in hemodynamically stable patients with severe coronary artery disease, when a heart team, including a cardiac surgeon, has determined high-risk PCI is the appropriate therapeutic option. Use of the HeartMate PHP Systems in these patients may prevent hemodynamic instability, which can result from repeat episodes of reversible myocardial ischemia that occur during planned temporary coronary occlusions and may reduce peri-and post-procedural adverse events.

Detailed description

Prospective, randomized, multi-center, open-label trial of the HeartMate PHP at up to 120 sites in the United States (U.S.). Control device will be any Abiomed Impella device approved for use in high-risk PCI. This clinical investigation is divided into two phases, a feasibility phase and a pivotal phase. * Feasibility Phase: Includes 75 roll-in and 120 randomized subjects registered under the clinical investigational plan (CIP) versions 2-4 at 48 sites in the U.S. prior to January 30, 2017 * Pivotal Phase: Includes subjects to be registered under Version F or a later version of the CIP at up to 120 sites in the U.S. Non-randomized Roll-in Cohort: Up to 480 subjects with the HeartMate PHP. Randomized Cohort: A minimum of 473 and a maximum of 716 subjects will be randomized in a 2:1 ratio to the HeartMate PHP and Impella.

Conditions

• Coronary Artery Disease

Interventions

Type	Name	Description
DEVICE	HeartMate PHP	The HeartMate PHP System is a temporary (\<6 hours) ventricular assist device indicated for use during high-risk percutaneous coronary interventions (PCI) performed electively or urgently in hemodynamically stable patients with severe coronary artery disease, when a heart team, including a cardiac surgeon, has determined high-risk PCI is an acceptable therapeutic option. Use of the HeartMate PHP Systems in these patients may prevent hemodynamic instability, which can result from repeat episodes of reversible myocardial ischemia that occur during planned temporary coronary occlusions and may reduce peri-and post-procedural adverse events.
DEVICE	Any Abiomed Impella® device approved for use in high-risk PCI	Any Abiomed Impella® device approved for use in high-risk PCI.

Timeline

• Start date: 2015-08-01
• Primary completion: 2021-05-17
• Completion: 2021-05-17
• First posted: 2015-06-11
• Last updated: 2022-06-28
• Results posted: 2022-06-28

Locations

58 sites across 1 country: United States

Regulatory

• FDA-regulated device study