Uncontrolled Hypertension Clinical Trial
Official title:
This is a Post Market, Multi-center, Open Label, Observational Study. Approximately 500 Subjects With Uncontrolled Hypertension Will Undergo Renal Artery Ablation
NCT number | NCT01996033 |
Other study ID # | CV-12-064-GE-HT |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | October 2013 |
Est. completion date | January 2017 |
Verified date | January 2019 |
Source | Abbott Medical Devices |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
The purpose of this observational study is to further evaluate the safety and performance of the EnligHTN™ Renal Denervation System in the treatment of patients with uncontrolled hypertension in clinical routine practice.
Status | Completed |
Enrollment | 25 |
Est. completion date | January 2017 |
Est. primary completion date | January 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Subject is planned to undergo a renal denervation procedure for the treatment of hypertension - Subject is =18 years of age at time of consent - Subject must be able and willing to provide written informed consent - Subject must be able and willing to comply with the required follow-up schedule - Subject has office Systolic Blood Pressure (SBP) = 140 mmHg - Subject has established hypertension (diagnosed =12 months prior to baseline) and is on a guideline based drug regimen at a stable (= 14 days) and a fully tolerated dose consisting of =3 anti-hypertensive medications (including 1 diuretic), or subject has documented drug intolerance to 2 or more of the 4 major classes of anti-hypertensives (ACE-I/ Angiotensin Receptor Blocker (ARB), Calcium Channel Blockers, Beta Blockers, or diuretic) and is unable to take 3 anti-hypertensive drugs Exclusion Criteria: - Subject has known significant renovascular abnormalities such as renal artery stenosis > 30% - Subject has undergone prior renal angioplasty, renal denervation, indwelling renal stents, and/or abdominal aortic stent grafts - Subject has a history of hemodynamically significant valvular heart disease - Subject has blood clotting abnormalities - Subject life expectancy is < 12 months, as determined by the Study Investigator - Subject is participating in another clinical study which has the potential |
Country | Name | City | State |
---|---|---|---|
Germany | Immanuelklinikum Bernau und Herzzentrum Brandenburg | Bernau | Brandenburg |
Germany | Augusta-Krankenhaus Düsseldorf | Düsseldorf | |
Germany | Medizinische Einrichtungen der Universität Düsseldorf | Düsseldorf | Northrhine-Westphalia |
Germany | Elisabeth-Krankenhaus Essen | Essen | Nordrhein-Westfalen |
Germany | Kliniken Oberallgäu gGmbH Klinik Immenstadt | Immenstadt | Bayern |
Germany | Universitätsklinikum Leipzig | Leipzig | Saxony |
Germany | Klinikum Oldenburg gGmbH | Oldenburg | Niedersachsen |
Germany | Klinikum Ernst von Bergmann | Potsdam | Brandenburg |
Germany | Diakonie-Klinikum Schwäbisch Hall gGmbH | Schwäbisch Hall | |
Germany | Asklepios Schwalm-Eder-Kliniken GmbH | Schwalmstadt | Hesse |
Germany | Kliniken Villingen-Schwenningen | Villingen-Schwenningen | Baden-Wurttemberg |
Germany | Kardiologische Praxis Wuppertal | Wuppertal | Northrhine-Westphalia |
Lead Sponsor | Collaborator |
---|---|
Abbott Medical Devices |
Germany,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Reduction in Office Diastolic Blood Pressure | Positive number indicates a reduction (improvement) in blood pressure | 6 Months | |
Other | Reduction in Office Diastolic Blood Pressure | Positive number indicates a reduction (improvement) in blood pressure | 12 Months | |
Other | Reduction in Office Systolic Blood Pressure | Positive number indicates a reduction (improvement) in blood pressure | 12 Months | |
Other | Reduction in 24 Hour Ambulatory Systolic Blood Pressure | Positive number indicates a reduction (improvement) in blood pressure | 12 Months | |
Other | Reduction in 24 Hour Ambulatory Diastolic Blood Pressure | Positive number indicates a reduction (improvement) in blood pressure | 12 Months | |
Other | Proportion of Subjects Achieving <140mmHg Office Systolic Blood Pressure | Positive number indicates a reduction (improvement) in blood pressure | 1 Month | |
Other | Proportion of Subjects Achieving <140mmHg Office Systolic Blood Pressure | Positive number indicates a reduction (improvement) in blood pressure | 6 Months | |
Other | Proportion of Subjects Achieving <140mmHg Office Systolic Blood Pressure | Positive number indicates a reduction (improvement) in blood pressure | 12 Months | |
Other | Change in Estimated Glomerular Filtration Rate (eGFR) | Change from baseline in eGFR | 12 Months | |
Primary | Mean Reduction in Office Systolic Blood Pressure at 6 Months | Positive number indicates a reduction (improvement) in blood pressure | 6 months |
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