NCT01872949: OPTIONS-HF

C-Pulse® System European Multicenter Study

Completed Results posted Last updated 8 August 2023

What this trial tests

trial in Heart Failure in 15 participants. Completed in 21 June 2018.

Timeline

13 January 2014

Primary endpoint
7 May 2018

21 June 2018

Quick facts

Lead sponsor	Nuwellis, Inc.
Status	Completed
Study type	OBSERVATIONAL
Enrollment	15
Start date	13 January 2014
Primary completion	7 May 2018
Estimated completion	21 June 2018
Sites	8 locations across Austria, Germany

Conditions studied

• Heart Failure — all drugs for Heart Failure →

Sponsor

Nuwellis, Inc. — full company profile →

Who can join

18 and older, any sex, with Heart Failure. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Survival and Study Completion Primary · 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.

Group	Value	95% CI
C-Pulse System	11
C-Pulse System	4

NYHA Classification Primary · 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

NYHA Class I

Group	Value	95% CI
C-Pulse System	2

NYHA Class II

Group	Value	95% CI
C-Pulse System	6

NYHA Class III

Group	Value	95% CI
C-Pulse System	4

NYHA Class IV

Group	Value	95% CI
C-Pulse System	0

INTERMACS Subject Profile/Status Primary · 6 months

1\. 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

Group	Value	95% CI
C-Pulse System	1
C-Pulse System	1
C-Pulse System	2
C-Pulse System	8

Six Minute Walk Test Primary · 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.

Group	Value	95% CI
C-Pulse System	333.9	± 112.2

KCCQ Primary · 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.

Group	Value	95% CI
C-Pulse System	60.3	± 21.1

Adverse events — posted to ClinicalTrials.gov

Time frame: 5 years. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

C-Pulse System

Serious: 14/15 (93%)

Deaths: 6/15

Serious adverse events (3 terms)

Reaction	System	C-Pulse System
Major Infection	Infections and infestations	—
Cardiac Arrhythmias	Cardiac disorders	—
Worsening Left Heart Failure	Cardiac disorders	—

Other adverse events (1 terms — click to expand)

Reaction	System	C-Pulse System
Dyspnea	Respiratory, thoracic and mediastinal disorders	—

Most-reported serious reactions: Major Infection, Cardiac Arrhythmias, Worsening Left Heart Failure.

Data from ClinicalTrials.gov NCT01872949 adverse events section.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Preliminary Results From the C-Pulse OPTIONS HF European Multicenter Post-Market Study.
   Schulz A, Krabatsch T, Schmitto JD, Hetzer R, et al · · 2016 · cited 12× · PMID 26887528 · DOI 10.12659/msmbr.896959