NL-OMON42639
Withdrawn
Not Applicable
Sympathy Redo: redo of renal denervation with a second generation device. - Sympathy Redo
niversitair Medisch Centrum Utrecht0 sites30 target enrollmentTBD
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- hypertensie
- Sponsor
- niversitair Medisch Centrum Utrecht
- Enrollment
- 30
- Status
- Withdrawn
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\.Individual is \*18 years of age.
- •2\. Individual has a mean day\-time SBP \* 135 mmHg, as determined with the use of ABPM, while the patient uses 3 or more antihypertensive agents for at least 3 months prior to inclusion or with documented intolerance to 2 or more of the 4 major classes antihypertensive drugs (ACE/ARB, Calcium channel blocker, Beta Blocker, Diuretic) and no possibility to take 3 anti\-hypertensive drugs.
- •3\. Individual has been treated with renal denervation as treatment for hypertension \* 12 months prior for inclusion.
- •4\. Individual has been treated with renal denervation, performed with the Symplicity Flex catheter.
- •5\. Individual has a decrease in systolic ABPM \< 10 mmHg compared to baseline.;The inclusion criteria are the same as for the Sympathy study, plus the addition of the last three criteria.
Exclusion Criteria
- •A potential subject who meets any of the following criteria will be excluded from participation in this study:;1\. Individual is unable or unwilling to sign informed consent.
- •2\. Individual has a treatable secondary cause of hypertension
- •3\. Individual has an eGFR below 20 mL/min/1\.73m2 using the MDRD calculation.
- •4\. Individual has renal artery anatomy that is ineligible for treatment.
- •5\. Individual has any serious medical condition, which in the opinion of the investigator, may adversely affect the safety and/or effectiveness of the participant or the study.
- •6\. Individual is pregnant, nursing or planning to be pregnant.
- •7\. Individual participates (participated) in the Sympathy study.;The exclusion criteria are the same as for the Sympathy study plus the last criteria.
Outcomes
Primary Outcomes
Not specified
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