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Pulmonary Artery Sensor for Heart Failure

Boston, MA

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 duration of study (to 5 years)

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

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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.Check my eligibility

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.See study design

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.

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Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ duration of study (to 5 years)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~duration of study (to 5 years)

This trial's timeline: 3 weeks for screening, Varies for treatment, and duration of study (to 5 years) 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- NYHA II Cohort - A composite of first HF event or death from Cardiovascular Death up to 24 months.

Efficacy- NYHA III Cohort (Phase I) - a composite of HF events or death from cardiovascular disease at 6 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 Arm

+4 more

Secondary study objectives

Eff-NYHA II Cohort & NYHA III Cohort -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 - NYHA II Cohort & NYHA III Cohort - Adherence to regular PAP and vital sign measurements including a sub-analysis on subjectswho move to another area of the country

Efficacy - NYHA II Cohort & NYHA III Cohort - All-cause mortality

+23 more

Other study objectives

Safety - NYHA III Cohort Phase II only: Incidence of serious adverse events at 12 months post Phase II randomization

Awards & Highlights

No Placebo-Only Group

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

Trial Design

8Treatment groups

Experimental Treatment

Group I: NYHA III Phase I 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 II: NYHA III Phase I 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. Once the primary endpoint (6 months) is met, subjects and clinicians will be unblinded to PAP.

Group III: NYHA III Clinician-Directed Patient Self-Management Arm (randomized)Experimental Treatment1 Intervention

This is Phase II / Randomization #2 following implant provided patient meets eligiibity criteria. Subjects will be instructed to take their PAP measurements daily in addition to their weight, BP, SpO2, and HR. All data, including PAP, will be visible to the patient. Subjects will manage their diuretics per protocol specific Clinician-Directed Patient Self-Management Treatment Guidelines. Clinicians will oversee the patient self-management to target PAP per protocol specific Treatment Guidelines and according to Guideline-Directed Medical Therapy.

Group IV: NYHA III Clinician Management Arm (randomized)Experimental Treatment1 Intervention

This is Phase II / Randomization #2 following implant provided patient meets eligiibity criteria. Subjects will be instructed to take their PAP measurements daily in addition to their weight, BP, SpO2, and HR. All data, including PAP, will be visible to the patient. Subjects will manage their diuretics per protocol specific Clinician-Directed Patient Self-Management Treatment Guidelines. Clinicians will manage the patients to target PAP per protocols specific to Treatment Guidelines and according to Guideline Directed Medical Therapy.

Group V: NYHA III Clinician Management Arm (Not randomized)Experimental Treatment1 Intervention

Subject will not be randomized if they do not meet eligibility criteria to potentially be randomized to Clinician-Directed Patient Self-Management. Subjects will be instructed to take their PAP measurements daily in addition to their weight, BP, SpO2, and HR. All data, including PAP, will be visible to the patient. Subjects will manage their diuretics per protocol specific Clinician-Directed Patient Self-Management Treatment Guidelines. Clinicians will manage the patients to target PAP per protocols specific to Treatment Guidelines and according to Guideline Directed Medical Therapy.

Group VI: NYHA II 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 VII: NYHA II 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 VIII: NYHA II 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. Once the primary endpoint (24 months) is met, subjects and clinicians will be unblinded to PAP.

0 / 1Eligibility criteria met