Hemodynamic Monitoring for Cardiogenic Shock
(HALO-Shock Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
Pilot Prospective Randomized Unblinded Pragmatic Trial of Pulmonary Artery Hemodynamic Monitoring Following Hospitalization for Cardiogenic Shock
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial team to get a clear answer.
Is the CardioMEMS device safe for humans?
How is the CardioMEMS HF System treatment different from other treatments for cardiogenic shock?
What data supports the effectiveness of the treatment CardioMEMS implantation for cardiogenic shock?
Research shows that the CardioMEMS device, which monitors pressure in the lungs, is effective in reducing hospitalizations and improving quality of life for heart failure patients. This suggests it could be beneficial for managing cardiogenic shock by helping doctors adjust treatments based on real-time pressure data.134510
Who Is on the Research Team?
Shashank Sinha, MD MSc
Principal Investigator
Inova Fairfax Medical Campus
Are You a Good Fit for This Trial?
This trial is for adults over 18 with heart failure who experience shortness of breath during mild activity. They must have survived a recent hospital stay due to cardiogenic shock, have internet and phone access, and be able to consent to the study. People with high procedural risks, no home discharge, pregnancy, infection, life expectancy under 6 months or on certain heart support treatments can't join.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Post-discharge Treatment
Participants receive either the CardioMEMS device implantation or standard of care following discharge from hospitalization for cardiogenic shock
Monitoring and Follow-up
Participants are monitored for safety and effectiveness, including health-related quality of life and NT-proBNP levels, with assessments at 2 and 6 months
What Are the Treatments Tested in This Trial?
Interventions
- CardioMEMS implantation with routine ambulatory pulmonary artery pressure monitoring and medication optimization
CardioMEMS implantation with routine ambulatory pulmonary artery pressure monitoring and medication optimization is already approved in United States for the following indications:
Find a Clinic Near You
Who Is Running the Clinical Trial?
Inova Health Care Services
Lead Sponsor
Abbott
Industry Sponsor
Dr. Etahn Korngold
Abbott
Chief Medical Officer
MD, Harvard Medical School
Robert B. Ford
Abbott
Chief Executive Officer since 2020
Bachelor's degree from Boston College, MBA from UC Berkeley, Haas School of Business