PROACTIVE-HF-2 Trial Heart Failure NYHA Class II and III

Description

This is a prospective, multi-center, open label, randomized control clinical trial evaluating the safety and efficacy of the Cordella™ Pulmonary Artery Sensor System in NYHA Class II-III Heart Failure Patients (PROACTIVE-HF-2 Trial). The study contains of 5 arms: NYHA II Cohort - To demonstrate safety and efficacy of the Cordella PA Sensor System in NYHA Class II HF patients, where patients have daily access to PAP data. * Treatment Arm (Group 1) * Active Control Arm (Group 2) * Crossover Arm (Group 3) NYHA III Cohort - To demonstrate safety and efficacy of the Cordella PA Sensor System in NYHA Class III HF patients, where patients have daily access to PAP data, including a randomized sub-study to evaluate a clinician-directed patient self-management strategy.

Conditions

Heart Failure NYHA Class II, Heart Failure NYHA Class III, Heart Failure

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Study Overview

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Study Details

Study overview

This is a prospective, multi-center, open label, randomized control clinical trial evaluating the safety and efficacy of the Cordella™ Pulmonary Artery Sensor System in NYHA Class II-III Heart Failure Patients (PROACTIVE-HF-2 Trial). The study contains of 5 arms: NYHA II Cohort - To demonstrate safety and efficacy of the Cordella PA Sensor System in NYHA Class II HF patients, where patients have daily access to PAP data. * Treatment Arm (Group 1) * Active Control Arm (Group 2) * Crossover Arm (Group 3) NYHA III Cohort - To demonstrate safety and efficacy of the Cordella PA Sensor System in NYHA Class III HF patients, where patients have daily access to PAP data, including a randomized sub-study to evaluate a clinician-directed patient self-management strategy.

A Prospective, Multi-Center, Open Label, Randomized Control Clinical Trial Evaluating the Safety and Efficacy of the Cordella™ Pulmonary Artery Sensor System in New York Heart Association (NYHA) Class II-III Heart Failure Patients

PROACTIVE-HF-2 Trial Heart Failure NYHA Class II and III

Condition
Heart Failure NYHA Class II
Intervention / Treatment

-

Contacts and Locations

Phoenix

St. Joseph's Hospital and Medical Center, Phoenix, Arizona, United States, 85013

Los Angeles

USC, Los Angeles, California, United States, 90033

San Francisco

UCSF Medical Center, San Francisco, California, United States, 94143

Miami

Baptist Health South Florida, Miami, Florida, United States, 33176

Pensacola

Ascension Sacred Heart, Pensacola, Florida, United States, 32504

Atlanta

Piedmont, Atlanta, Georgia, United States, 30309

Downers Grove

Advocate Health System, Downers Grove, Illinois, United States, 60515

Palos Park

Heart Care Centers of Illinois (HCCI), Palos Park, Illinois, United States, 60464

Indianapolis

Ascension St. Vincent's, Indianapolis, Indiana, United States, 46260

Kansas City

University of Kansas Medical Center (KUMC), Kansas City, Kansas, United States, 66160

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • 1. ACC/AHA Stage D refractory HF (including a known history of \>24 hours of IV inotropic therapy to support circulation within the past 6 months (other than relation to a procedure))
  • 2. Subjects with history of recurrent pulmonary embolism (≥2 episodes within 5 years prior to Screening Visit) and/or deep vein thrombosis in the femoral or IJ vein used for access (\< 3 month prior to Screening Visit)
  • 3. Subjects with a resting systolic blood pressure \<90 mmHg and/ or severe pre-capillary pulmonary hypertension with a pulmonary artery systolic pressure of ≥70 mm/Hg with pulmonary capillary wedge pressure ≤ 15 mmHg at the Cordella PA Sensor Implant RHC (V2)
  • 4. Subjects who have had a major cardiovascular (CV) event (e.g., myocardial infarction, stroke) within 3 months of the Screening Visit
  • 5. Unrepaired severe valvular disease
  • 6. Subjects with significant congenital heart disease that has not been repaired and would prevent implantation of the Cordella PA Sensor or mechanical/tissue right heart valve(s)
  • 7. Subjects with known coagulation disorders
  • 8. Subjects with a hypersensitivity or allergy to platelet aggregation inhibitors including aspirin, clopidogrel, prasugrel, and ticagrelor; or patients unable to take dual antiplatelet or anticoagulants for one-month post implant
  • 9. Known history of life-threatening allergy to contrast dye.
  • 10. Subjects whereby RHC is contraindicated
  • 11. Subjects with an active infection at the Cordella Sensor Implant Visit
  • 12. Subjects with a GFR \<20 ml/min or who are on chronic renal dialysis
  • 13. Implanted with Cardiac Resynchronization Therapy-Pacemaker (CRT-P) or Cardiac Resynchronization Therapy-Defibrillator (CRT-D), or having undergone mitral/tricuspid valve repair/replacement within 90 days or catheter ablation for atrial fibrillation within 30 days prior to screening visit
  • 14. Received or are likely to receive an advanced therapy (e.g., durable mechanical circulatory support or lung or heart transplant) in the next 24 months
  • 15. Subjects who are pregnant or breastfeeding
  • 16. Subjects who are unwilling or deemed by the Investigator to be unwilling to comply with the study protocol, or subjects with a history of non-compliance
  • 17. Severe illness, other than heart disease, which would limit survival to \<2 years
  • 18. Subjects whose clinical condition, in the opinion of the Investigator, makes them an unsuitable candidate for the study
  • 19. Subjects enrolled in another investigational trial with an active Treatment Arm
  • 20. Subject who is in custody by order of an authority or a court of law

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Endotronix, Inc.,

Andrea Sauerland, STUDY_DIRECTOR, Endotronix, Inc.

Study Record Dates

2033-09