Overview

This trial is active, not recruiting.

Condition heart failure
Sponsor Sunshine Heart Inc.
Start date May 2013
End date December 2018
Trial size 50 participants
Trial identifier NCT01872949, PRO 04654-C

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model case-only
Time perspective prospective

Primary Outcomes

Measure
Freedom from worsening heart failure resulting in hospitalization, LVAD implantation, or death
time frame: 12 Months
All Protocol Defined Adverse Events
time frame: 12 Months

Secondary Outcomes

Measure
Improvement in LVEF, QOL Scores and 6MHW
time frame: 6 and 12 Months

Eligibility Criteria

Male or female participants at least 18 years old.

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)

Additional Information

Official title C-Pulse System eurOPean mulTicenter Study, Implantable cOuNterpulsation System in patIents With Moderate to Severe Heart Failure
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.
Trial information was received from ClinicalTrials.gov and was last updated in March 2016.
Information provided to ClinicalTrials.gov by Sunshine Heart Inc..