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Completed

NCT Number: NCT01872949

C-Pulse® System European Multicenter Study

The study is designed to observe the clinical outcomes of heart failure patients treated with C-Pulse® System in the usual manner and according to the approved indications and contraindications.

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Key information

Conditions

Heart Failure Cardiovascular Diseases Heart Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital, Innsbruck, Austria

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About this study

Evaluation of the post-market clinical performance and safety of the C-Pulse® System for the treatment of Heart Failure in the population of patients who meet the approved clinical conditions provided in the indications and contraindications.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patient is 18 years or older
  • Patients with moderate to severe ambulatory heart failure [American College of Cardiology/American Heart Association (ACC/AHA) Stage C; NYHA Class III/IV ambulatory], who are refractory to optimal medical therapy
  • Patients who are non-responders to CRT pacemaker therapy
  • Patient has signed and dated the investigation informed consent form

Exclusion criteria

  • Evidence of significant ascending aortic calcification on postero-anterior chest X-ray or CT scan
  • Moderate or severe atherosclerotic aortic disease
  • Ascending aorto-coronary artery bypass grafts
  • Any history of aortic dissection
  • Connective tissue disorder such as Marfans disease
  • Aorta not conforming to specified dimensional constraints
  • Patient has severe mitral valve incompetence, grade 4+
  • Patient has moderate to severe aortic valve incompetence, grade 2 - 4+
  • Patient has systolic blood pressure less than 90 or greater than 140mmHg
  • Presence of active systemic infection
  • Presence of bleeding or coagulation disorder (relative)

Treatment and study plan

Primary outcomes

  1. Survival and Study Completion

    Time frame: 5 years

    Amount of participants that did not exit study for reasons including worsening heart failure resulting in hospitalization, LVAD implantation, study withdrawal or death.

  2. NYHA Classification

    Time frame: 6 Months

    Participant NYHA Classification at 6 month follow up. The NYHA Classification involved 4 classes.

    I No limitation of physical activity II Slight limitation of physical activity III Marked limitation of physical activity IV Unable to carry on any physical activity without discomfort

  3. INTERMACS Subject Profile/Status

    Time frame: 6 months

    • Critical Cardiogenic Shock, 2. Progressive Decline, 3. Stable but Inotrope Dependent, 4. Resting Symptoms, 5. Exertion Intolerant, 6. Exertion Limited, 7. Advanced NYHA Class III, 8. NA/NYHA class I or II

  4. Six Minute Walk Test

    Time frame: 6 months

    The six-minute walk test (6MWT) measures the distance an individual is able to walk over a total of six minutes on a hard, flat surface. The goal is for the individual to walk as far as possible in six minutes. The individual is allowed to self-pace and rest as needed as they traverse back and forth along a marked walkway.

  5. KCCQ

    Time frame: 6 months

    Overall score from Kansas City Cardiomyopathy Questionnaire, a 23-item self-administered questionnaire developed to independently measure the patient's perception of their health status,which includes heart failure symptoms, impact on physical and social function, and how their heart failure impacts their quality of life (QOL) within a 2-week recall period. Scores range from 0-100, in which higher scores reflect better health status.

Sponsors and collaborators

Lead sponsor

Nuwellis, Inc.

Industry

Registry information

Official study title

C-Pulse System eurOPean mulTicenter Study, Implantable cOuNterpulsation System in patIents With Moderate to Severe Heart Failure

Acronym: OPTIONS-HF

Important dates

Study start
2014
Primary completion
2018
Study completion
2018
First posted
Jun 7, 2013
Registry last updated
Aug 8, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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