Status:
COMPLETED
C-Pulse® System European Multicenter Study
Lead Sponsor:
Nuwellis, Inc.
Conditions:
Heart Failure
Eligibility:
All Genders
18+ years
Brief 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.
Detailed 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...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
January 13 2014
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 21 2018
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT01872949
Start Date
January 13 2014
End Date
June 21 2018
Last Update
August 8 2023
Active Locations (8)
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1
University Hospital
Innsbruck, Austria, 6020
2
Evangelisches Krankenhaus Niederrhein
Duisburg, Northrhine-Westfalia, Germany, 47169
3
Cardio-Centrum Berlin
Berlin, Germany, 10117
4
Vivantes Klinikum
Berlin, Germany, 10249