BRIDGE-HF
Evaluates innovative treatment strategies (including mechanical circulatory support devices, regenerative therapies, and minimally invasive surgical procedures) to prevent further progression of advanced cardiovascular disease, stabilize cardiac function, and promote recovery of damaged heart and vascular tissues.
Study overview
This study investigates the use of the Impella 5.5 heart pump as temporary mechanical circulatory support in patients with severe but potentially reversible heart failure.The device provides temporary mechanical support to allow the heart time to recover while maintaining adequate circulation. The study will evaluate the safety and feasibility of this approach, as well as its potential to restore heart function, improve patient recovery, and reduce the need for permanent mechanical support or heart transplantation.
Objectives
General
Develop and evaluate innovative treatment approaches for patients with advanced cardiovascular disease who have limited therapeutic options remaining. Work Package 4 (WP4) focuses on providing a potential “late-stage treatment pathway” by restoring heart function, promoting recovery, or improving quality of life in patients with end-stage heart failure or complex coronary artery disease. To achieve this, WP4 integrates regenerative therapies, mechanical circulatory support, minimally invasive surgical techniques, and ex vivo heart perfusion technologies. The overall aim is to improve survival, enhance functional recovery, and reduce dependence on long-term mechanical support or heart transplantation in patients with otherwise poor clinical prospects.
Primary
Evaluate whether temporary support with the Impella 5.5 heart pump is a safe and feasible treatment option for patients with severe but potentially reversible heart failure. The device may provide the heart with time to recover while also helping clinicians determine the most appropriate long-term treatment strategy.
Secondary
- Assess how often heart recovery is sufficient to avoid implantation of a long-term heart assist device (LVAD).
- Measure changes in heart function during and after treatment.
- Monitor treatment-related complications and adverse events.
Study design
This early-stage feasibility study will enroll patients with severe but potentially reversible heart failure. All participants will be treated with the Impella 5.5 device and followed over time to assess the safety and potential benefits of this approach.
Participating sites
- UMC Utrecht — Netherlands
Consortium partners
Organisations contributing sites, technology, or expertise to this clinical study.