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Pulmonary Artery Sensor for Heart Failure

N/A

Recruiting

Research Sponsored by Endotronix, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

6. Subjects should be on diuretic therapy ([≥40 mg] furosemide or equivalent) for ≥ 1 month at time of Screening

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months and 24 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing the safety and effectiveness of the Cordella Pulmonary Artery Sensor System in patients with heart failure. There are five groups in the study, each with a different approach to using the

Who is the study for?

This trial is for adults with heart failure who've been treated for at least 3 months and are in NYHA Class II or III. They should be on stable heart failure medication as per guidelines, though exceptions can be made if they're intolerant or cannot afford these medications. Recent hospitalization for heart failure and certain levels of NT-proBNP (a heart stress marker) are also required.

What is being tested?

The PROACTIVE-HF-2 Trial is testing the Cordella™ Pulmonary Artery Sensor System's safety and effectiveness in patients with different severities of heart failure. It includes five groups: some getting the device, others serving as controls, and a group that switches from control to treatment.

What are the potential side effects?

While specific side effects aren't listed here, similar devices may cause complications like infection risk at the implant site, bleeding during implantation procedure, blood vessel damage, arrhythmias (irregular heartbeat), or sensor malfunction.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have been on a water pill (like furosemide 40 mg or more) for at least a month.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months and 24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 months and 24 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months and 24 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Efficacy- Randomized Arm - A composite of first HF event or death from Cardiovascular Death up to 24 months.

Efficacy- Single Arm- 12 month incidence of HF related Hospitalizations (HFH) or all-cause mortality

Safety- Randomized Arm- Freedom from device/system related complication

+3 more

Secondary study objectives

Eff-Rando and SA -time to death, # HFH or urgent HF visits, time to first HFH or urgent HF visit, diff >/= 15 KCCQ BSL to 24 mos,diff >/= 10 in KCCQ BSL to 24 mos, diff >/= 5 in KCCQ BSL to 24 mos, diff >/= 30m in 6 MWT BSL to 24 mos

Efficacy - Randomized Arm - Incidence of HF hospitalizations or all-cause mortality

Efficacy - Randomized and SIngle Arm - Various measurements via ECHO and evaluated by ECHO core lab at Baseline, 12, 24, 36, 48 and 60 months.

+23 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

5Treatment groups

Experimental Treatment

Group I: Single Arm- Clinician-Directed Patient Self-Management ArmExperimental Treatment1 Intervention

All subjects will receive the Cordella Sensor. Subjects will self-manage their Loop diuretics per protocol specific Clinician-Directed Patient Self-Management Treatment Guidelines and Clinicians will manage the patients according to Guideline-Directed Medical Therapy.

Group II: Single Arm- Clinician Management ArmExperimental Treatment1 Intervention

All subjects will receive the Cordella Sensor. Clinicians will manage the subjects to target PAP per protocols specific Treatment Guidelines and according to Guideline-Directed Medical Therapy.

Group III: Randomized Arm- Treatment ArmExperimental Treatment1 Intervention

All subjects will receive the Cordella Sensor. Clinicians will manage the subjects to target PAP per protocols specific Treatment Guidelines and according to Guideline-Directed Medical Therapy.

Group IV: Randomized Arm- Crossover ArmExperimental Treatment1 Intervention

All subjects will receive the Cordella Sensor. At least 12 months following implant and following an adjudicated HFH, subjects in the Active Control Arm can qualify to crossover to the Crossover Arm and both patients and clinicians would then be unmasked to PAP. Clinicians will then manage the subjects to target PAP per protocols specific Treatment Guidelines and according to Guideline-Directed Medical Therapy.

Group V: Randomized Arm- Active Control ArmExperimental Treatment1 Intervention

All subjects will receive the Cordella Sensor. Clinicians will manage subjects using the subjects daily data trends (BP, weight, HR, SpO2 symptoms) according to Guideline Directed Medical Therapy.

0 / 1Eligibility criteria met