C-Pulse® System European Multicenter Study

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

15 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-01-13

Study Completion Date

2018-06-21

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Heart Failure

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No