NL-OMON40689
Recruiting
Not Applicable
Endovascular Renal Sympathetic Denervation using the Boston Scientific Vessix V2 renal denervation system to Improve Heart Failure - IMPROVE-HF-I
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Heart failure
- Sponsor
- Erasmus MC, Universitair Medisch Centrum Rotterdam
- Enrollment
- 70
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Age \>\=18 years;
- •2\. Systolic ejection fraction (established on echo) \<35%;
- •3\. NYHA Class II, III or IV heart failure despite optimal heart failure therapy;
- •4\. Renal arteries suitable for the proposed treatment;
- •5\. A glomerular filtration rate of 30ml/min/1\.73m2 or more;
- •6\. Written informed consent;
- •7\. The patient agrees to the follow\-up.
Exclusion Criteria
- •1\. Pregnancy;
- •2\. Renal artery abnormalities;
- •3\. Acute heart failure;
- •4\. A systolic office based blood pressure of \<110mmHg systolic;
- •5\. Recent (\<3months) stroke or myocardial infarction
- •6\. Hypertrophic obstructive cardiomyopathy, constrictive pericarditis
- •7\. The patient has other medical illness (i.e., cancer) that may cause the patient to be non\-compliant with the protocol, confound the data interpretation or is associated with limited life expectancy (i.e., less than one year);
Outcomes
Primary Outcomes
Not specified
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