PROACTIVE-HF-2 Trial for Heart Failure
This study is testing the Cordella™ Pulmonary Artery Sensor System (a device that measures heart pressure) in people with heart failure. It aims to see if using this system can help manage heart failure and reduce problems like hospitalizations or death. You might be able to join if you are at least 18 years old, have been diagnosed with heart failure for at least three months, and have NYHA Class II or Class III heart failure (meaning you have some limitations due to your heart failure). The study will look at how well the device works over 6 to 24 months and also check for any device-related safety issues. The current status of this study is unclear, but it plans to enroll 1750 participants.
- Study design
- This is a prospective, multi-center, open-label, randomized controlled clinical trial with 1750 planned participants. It has five groups, including treatment, control, and crossover arms for different stages of heart failure.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for up to 24 months to assess the effectiveness and safety of the device.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
PROACTIVE-HF-2 Trial Heart Failure NYHA Class II and III
At a glance
Conditions
NCT05934487
Where you'd take part
This study runs at 48 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
Ascension Sacred Heart
Pensacola, Floridastudy coordinator listed
Recruiting
Medical University of South Carolina (MUSC)
Charleston, South Carolinastudy coordinator listed
Recruiting
Providence St. Vincent's - Portland
Portland, Oregonstudy coordinator listed
Recruiting
UNC Medical Center
Durham, North Carolinastudy coordinator listed
Recruiting
Advocate Aurora St. Luke's
Milwaukee, Wisconsinno site contact published
Recruiting
Advocate Health System
Downers Grove, Illinoisno site contact published
Recruiting
Ascension Providence Hospital Cardiology - Heart Cardiology
Howell, Michiganno site contact published
Recruiting
Ascension St. Vincent's
Indianapolis, Indianano site contact published
Recruiting
Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.
Study leadership
- Edward Karst · STUDY_DIRECTOR · Edwards Lifesciences IHFM
Who to contact
Opens a ready-to-send draft in your own email app — review before sending.
What this trial measures
- Efficacy- NYHA II Cohort - A composite of first HF event or death from Cardiovascular Death up to 24 months.24 months
A composite endpoint of first HF event or death from CVD up to 24 months.
- Efficacy- NYHA III Cohort (Phase I) - a composite of HF events or death from cardiovascular disease at 6 months12 months
A composite of HF events or death from cardiovascular disease at 6 months
- Safety- Randomized Arm- Freedom from device/system related complication24 months
Freedom from device/system related complication at 24 months
- Safety- Randomized Arm-Freedom from pressure sensor failure24 months
Freedom from pressure sensor failure at 24 months
- Safety- Single Arm-Freedom from device/system related complication12 months
Freedom from device/system related complication at 12 months
- Safety- Single Arm- Freedom from pressure sensor failure12 months
Freedom from pressure sensor failure at 12 months
- Efficacy- NYHA III Cohort (Phase II) - A test of non-inferiority at 12 months of the percentage of patients at or below trend seated mPAP of 25 mmHg in (i) Clinician-Directed Patient Self-Management vs. (ii) Clinician Management Arm12 months
A test of non-inferiority at 12 months of the percentage of patients at or below trend seated mPAP of 25 mmHg in (i) Clinician-Directed Patient Self-Management vs. (ii) Clinician Management Arm