C-Pulse® System European Multicenter Study

Heart Failure Clinical Trial

— OPTIONS-HF  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01872949
• Other study ID #: PRO 04654-C
• Status: Completed
• Start date: January 13, 2014
• Est. completion date: June 21, 2018

Study information

• Verified date: August 2023
• Source: Nuwellis, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: June 21, 2018
• Est. primary completion date: May 7, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Heart Failure

Locations

Country	Name	City	State
Austria	University Hospital	Innsbruck
Germany	Cardio-Centrum Berlin	Berlin
Germany	Unfallkrankenhaus	Berlin
Germany	Vivantes Klinikum	Berlin
Germany	Evangelisches Krankenhaus Niederrhein	Duisburg	Northrhine-Westfalia
Germany	Universitätsklinikum Erlangen	Erlangen
Germany	Medizinische Hochschule	Hannover
Germany	Universität Tübingen	Tübingen

Sponsors (1)

Lead Sponsor	Collaborator
Nuwellis, Inc.

Countries where clinical trial is conducted

Austria,  Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Survival and Study Completion	Amount of participants that did not exit study for reasons including worsening heart failure resulting in hospitalization, LVAD implantation, study withdrawal or death.	5 years
Primary	NYHA Classification	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	6 Months
Primary	INTERMACS Subject Profile/Status	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	6 months
Primary	Six Minute Walk Test	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.	6 months
Primary	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.	6 months