Trial Outcomes & Findings for C-Pulse® System European Multicenter Study (NCT NCT01872949)

NCT ID: NCT01872949

Last Updated: 2023-08-08

Results Overview

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

• Recruitment status: COMPLETED
• Target enrollment: 15 participants
• Primary outcome timeframe: 5 years
• Results posted on: 2023-08-08

Participant Flow

The OPTIONS-HF is a prospective, post-market, open label study designed to enroll up to 50 patients in up to fifteen (15) European sites. Only 15 subjects were implanted.

Participant milestones

Measure	C-Pulse System Single-arm study
Overall Study STARTED	15
Overall Study COMPLETED	4
Overall Study NOT COMPLETED	11

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Number analyzed is different from overall participants because one participant did not take the KCCQ.

Baseline characteristics by cohort

Measure	C-Pulse System n=15 implants A total of 15 subjects were treated with the C-Pulse System.
Age, Continuous	62 years STANDARD_DEVIATION 9.3 • n=15 Participants
Age, Customized Median	61 years n=15 Participants
Sex: Female, Male Female	3 Participants n=15 Participants
Sex: Female, Male Male	12 Participants n=15 Participants
Race/Ethnicity, Customized Race · European Caucasian	14 Participants n=15 Participants
Race/Ethnicity, Customized Race · Subject Choose not to Provide	1 Participants n=15 Participants
Region of Enrollment Austria	1 Participants n=15 Participants
Region of Enrollment Germany	13 Participants n=15 Participants
Region of Enrollment United Kingdom	1 Participants n=15 Participants
NYHA Classification I	0 Participants n=15 Participants
NYHA Classification II	0 Participants n=15 Participants
NYHA Classification III	14 Participants n=15 Participants
NYHA Classification IV	1 Participants n=15 Participants
INTERMACS Subject Profile/Status Resting Symptoms	3 Participants n=15 Participants
INTERMACS Subject Profile/Status Exertion Intolerant	5 Participants n=15 Participants
INTERMACS Subject Profile/Status Exertion Limited	4 Participants n=15 Participants
INTERMACS Subject Profile/Status Advanced NYHA Class III	1 Participants n=15 Participants
INTERMACS Subject Profile/Status NA, NYHA class I or II	2 Participants n=15 Participants
Six Minute Walk Test	237.4 meters STANDARD_DEVIATION 85.6 • n=15 Participants
Kansas City Cardiomyopathy Questionnaire	30 points STANDARD_DEVIATION 18.5 • n=14 Participants • Number analyzed is different from overall participants because one participant did not take the KCCQ.

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	C-Pulse System n=15 Participants A total of 15 subjects were treated with the C-Pulse System.
Survival and Study Completion Exited Study	11 Participants
Survival and Study Completion Study completion	4 Participants

PRIMARY outcome

Timeframe: 6 Months

Population: Only 12 participants remained in the study at the 6-month follow-up.

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

Outcome measures

Measure	C-Pulse System n=12 Participants A total of 15 subjects were treated with the C-Pulse System.
NYHA Classification NYHA Class I	2 Participants
NYHA Classification NYHA Class II	6 Participants
NYHA Classification NYHA Class III	4 Participants
NYHA Classification NYHA Class IV	0 Participants

PRIMARY outcome

Timeframe: 6 months

Population: Only 12 participants remained in the study at the 6-Month follow-up.

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

Outcome measures

Measure	C-Pulse System n=12 Participants A total of 15 subjects were treated with the C-Pulse System.
INTERMACS Subject Profile/Status Resting Symptoms	1 Participants
INTERMACS Subject Profile/Status Exertion Limited	1 Participants
INTERMACS Subject Profile/Status Advanced NYHA Class III	2 Participants
INTERMACS Subject Profile/Status NA, NYHA class I or II	8 Participants

PRIMARY outcome

Timeframe: 6 months

Population: Only 9 participants were able to be assessed via 6MWT at the 6-Month follow-up.

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.

Outcome measures

Measure	C-Pulse System n=9 Participants A total of 15 subjects were treated with the C-Pulse System.
Six Minute Walk Test	333.9 Meters Standard Deviation 112.2

PRIMARY outcome

Timeframe: 6 months

Population: Only 12 participants were involved in the study at the time of KCCQ.

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.

Outcome measures

Measure	C-Pulse System n=12 Participants A total of 15 subjects were treated with the C-Pulse System.
KCCQ	60.3 score on a scale Standard Deviation 21.1

Adverse Events

C-Pulse System

Serious events: 14 serious events

Other events: 2 other events

Deaths: 6 deaths

Serious adverse events

Measure	C-Pulse System n=15 participants at risk A total of 15 subjects were treated with the C-Pulse System. The study follow-up period was up to 5 years. However, the data collection for subjects was up to 24-months. Only 3 subjects completed the 24 months follow-up visit, and 12 subjects prematurely exited the study prior to the 24 months follow-up. \\Rate subjects with averse event 93% (14/15).
Infections and infestations Major Infection	46.7% 7/15 • Number of events 8 • 5 years Events for the C-Pulse European study were reported by Investigators using the INTERMACS ™ Adverse Event Definitions as a guideline.
Cardiac disorders Cardiac Arrhythmias	33.3% 5/15 • Number of events 5 • 5 years Events for the C-Pulse European study were reported by Investigators using the INTERMACS ™ Adverse Event Definitions as a guideline.
Cardiac disorders Worsening Left Heart Failure	33.3% 5/15 • Number of events 13 • 5 years Events for the C-Pulse European study were reported by Investigators using the INTERMACS ™ Adverse Event Definitions as a guideline.

Other adverse events

Measure	C-Pulse System n=15 participants at risk A total of 15 subjects were treated with the C-Pulse System. The study follow-up period was up to 5 years. However, the data collection for subjects was up to 24-months. Only 3 subjects completed the 24 months follow-up visit, and 12 subjects prematurely exited the study prior to the 24 months follow-up. \\Rate subjects with averse event 93% (14/15).
Respiratory, thoracic and mediastinal disorders Dyspnea	13.3% 2/15 • Number of events 4 • 5 years Events for the C-Pulse European study were reported by Investigators using the INTERMACS ™ Adverse Event Definitions as a guideline.

Additional Information

Audrey Singh

CHF Solutions, Inc.

Phone: 952-345-4217

Email: audrey.singh@chf-solutions.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place