N/A
Completed N=15
C-Pulse® System European Multicenter Study
Source: ClinicalTrials.gov NCT01872949 ↗Enrolled (actual)
15
Serious AEs
93.3%
Results posted
Aug 2023
Primary outcomePrimary: Survival and Study Completion — 11; 4 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Survival and Study Completion |
11; 4 | — |
| PRIMARY NYHA Classification |
2; 6; 4; 0 | — |
| PRIMARY INTERMACS Subject Profile/Status |
1; 1; 2; 8 | — |
| PRIMARY Six Minute Walk Test |
333.9 | — |
| PRIMARY KCCQ |
60.3 | — |
Eligibility Criteria
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)
Data sourced from ClinicalTrials.gov (NCT01872949). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.