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The Study objective is to assess the performance of the Vessix V2 Renal Denervation System for the treatment of uncontrolled hypertension using an innovative percutaneous Radio Frequency (RF) balloon catheter renal denervation device.
This study will evaluate the hypothesis that the Vessix V2 Renal Denervation System can be employed to reduce systolic and diastolic blood pressure at 6 months as compared to pre-treatment baseline blood pressures.
Patient blood pressure will be measured by in the office according to recognized international techniques and standards.
Procedural success shall be defined as ability to complete the renal denervation treatment using the V2 balloon catheter device and RF generator.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Renal Denvervation | Other | All subjects who meet the inclusion criteria and are enrolled in this trial will be treated with the Vessix Renal Denervation System. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Renal Denervation | Device | percutaneous renal denervation using the Vessix RF balloon catheter |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in Systolic and Diastolic Blood Pressure at Six (6) Months as Measured by Office-based Blood Pressure Assessment | Change in systolic and diastolic blood pressure at six (6) months as measured by office-based blood pressure assessment following therapeutic renal denervation compared to baseline. Office blood pressure will be measured using a validated electronic device according to a standardized procedure. . | Baseline and 6 months |
| Change in Systolic and Diastolic Blood Pressure at Six (6) Months as Measured by 24-hour Ambulatory Blood Pressure | Change in systolic and diastolic blood pressure at six (6) months as measured by 24-hour ambulatory blood pressure monitoring (ABPM) following therapeutic renal denervation compared to baseline using a validated ABPM device. | Baseline and 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Absence of Flow Limiting Stenosis in the Renal Artery | Absence of flow limiting stenosis in the renal artery at six (6) months follow up time point as measured by renal duplex ultrasound | 6 months |
| Renal Artery Dissection or Perforation During the Procedure That Requires Stenting or Surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Horst Sievert, M.D. | CardioVascular Center Frankfurt, Germany | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St. Vincent's Hospital | Sydney | New South Wales | 2010 | Australia | ||
| The Prince Charles Hospital, Cardiology Clinical Research Centre |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25452197 | Result | Sievert H, Schofer J, Ormiston J, Hoppe UC, Meredith IT, Walters DL, Azizi M, Diaz-Cartelle J, Cohen-Mazor M. Renal denervation with a percutaneous bipolar radiofrequency balloon catheter in patients with resistant hypertension: 6-month results from the REDUCE-HTN clinical study. EuroIntervention. 2015 Feb;10(10):1213-20. doi: 10.4244/EIJY14M12_01. | |
| 25186534 |
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Enrollment of up to 150 subjects was planned; 146 subjects were enrolled at 23 centers in the Europe, Australia and New Zealand from February 22, 2012 to April 8, 2013.
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| ID | Title | Description |
|---|---|---|
| FG000 | Renal Denervation | All subjects who meet the inclusion criteria and are enrolled in this trial will be treated with the Vessix Renal Denervation System. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Duration of the procedure (average of 65 minutes) |
| Renal Artery Infarction or Embolus | Duration of the procedure (average of 65 minutes) |
| Cerebrovascular Accident (CVA) at Time of Procedure | Duration of the procedure (average of 65 minutes) |
| Myocardial Infarction at Time of Procedure | Duration of the procedure (average of 65 minutes) |
| Sudden Cardiac Death at Time of Procedure | Duration of the procedure (average of 65 minutes) |
| Angiographically-documented Renal Stenosis Requiring an Intervention | 2 Years |
| Chronic Symptomatic Orthostatic Hypotension | 2 Years |
| Hypertensive Emergency Necessitating Hospital Admission (Unrelated to Medication and/or Non-compliance) | 2 Years |
| Reduction in Estimated Glomerular Filtration Rate (eGFR) >25% | 2 Years |
| Brisbane |
| Queensland |
| 4032 |
| Australia |
| Royal Adelaide Hospital | Adelaide | South Australia | 5000 | Australia |
| Flinders Medical Centre | Bedford Park | South Australia | 5042 | Australia |
| Monash Cardiovascular Research Centre (Monash Heart) | Clayton | Victoria | 3168 | Australia |
| AKH Linz | Linz | 4020 | Austria |
| Salzburger Landeskliniken Universitats Krankenhaus | Salzburg | A-5020 | Austria |
| OLV Ziekenhuis | Aalst | Belgium |
| Cliniques Universiaires Saint-Luc | Brussels | Belgium |
| Hôpital Européen Georges Pompidou | Paris | France |
| Clinic Pasteur | Toulouse | F-31076 | France |
| Zentralklinik Bad Berka GmbH | Bad Berka | 99437 | Germany |
| Kardiologische Praxis Main-Taunus | Bad Soden/Taunus | 65812 | Germany |
| Vascular Center Berlin, Ev. Königin Elisabeth Hospital | Berlin | 10365 | Germany |
| St. Vincenz Krankenhaus Abt. Kardiologie | Essen | 45141 | Germany |
| CardioVascular Center, Sankt Katharinen Krakenhaus | Frankfurt | 60389 | Germany |
| Hamburg University Cardiovascular Center | Hamburg | 22527 | Germany |
| Saarland University Hospital Department of Internal Medicine III Non-surgical Intensive Care, Cardiology and Angiology | Homburg/Saar | D-66421 | Germany |
| University Leipzig | Leipzig | 04109 | Germany |
| German Heart Center Munich | Münich | 80636 | Germany |
| Academic Medical Center | Amsterdam | 1105AZ | Netherlands |
| Erasmus Medical Center-Thorax Center | Rotterdam | 3015CE | Netherlands |
| Auckland City Hospital | Grafton | Auckland | 1023 | New Zealand |
| Mercy Angiography Unit Ltd | Auckland | 1023 | New Zealand |
| University Hospital of Geneva, Cardiology Center | Geneva | 1211 | Switzerland |
| Switzerland University Hospital Clinic for Cardiology | Zurich | 8091 | Switzerland |
| Persu A, Sapoval M, Azizi M, Monge M, Danse E, Hammer F, Renkin J. Renal artery stenosis following renal denervation: a matter of concern. J Hypertens. 2014 Oct;32(10):2101-5. doi: 10.1097/HJH.0000000000000323. No abstract available. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Renal Denervation | All subjects who meet the inclusion criteria and are enrolled in this trial will be treated with the Vessix Renal Denervation System. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| ||||||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Number | participants |
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| Region of Enrollment | Number | participants |
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| Type 2 Diabetes | Number | participants |
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| Coronary Artery Disease | Number | participants |
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| Congestive Heart Failure | Number | participants |
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| Dyslipidemia | Number | participants |
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| Baseline Systolic Blood Pressure | Mean | Standard Deviation | mm Hg |
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| Baseline Diastolic Blood Pressure | Mean | Standard Deviation | mm Hg |
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| Heart Rate | Mean | Standard Deviation | beats/min |
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| Estimated glomerular filtration rate (eGFR) | Mean | Standard Deviation | mL/min/1.73m^2 |
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| Serum Creatinine | Mean | Standard Deviation | micromol/L |
| ||||||||||||||||||||||
| Number of Antihypertensive Medications per Patient | Mean | Standard Deviation | Antihypertensive Medications per Patient |
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| Antihypertensive Medications | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Systolic and Diastolic Blood Pressure at Six (6) Months as Measured by Office-based Blood Pressure Assessment | Change in systolic and diastolic blood pressure at six (6) months as measured by office-based blood pressure assessment following therapeutic renal denervation compared to baseline. Office blood pressure will be measured using a validated electronic device according to a standardized procedure. . | Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 3 participants were not evaluable. | Posted | Mean | Standard Deviation | mm Hg | Baseline and 6 months |
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| Secondary | Absence of Flow Limiting Stenosis in the Renal Artery | Absence of flow limiting stenosis in the renal artery at six (6) months follow up time point as measured by renal duplex ultrasound | Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 3 participants were not evaluable. | Posted | Number | participants w/o flow limiting stenosis | 6 months |
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| Primary | Change in Systolic and Diastolic Blood Pressure at Six (6) Months as Measured by 24-hour Ambulatory Blood Pressure | Change in systolic and diastolic blood pressure at six (6) months as measured by 24-hour ambulatory blood pressure monitoring (ABPM) following therapeutic renal denervation compared to baseline using a validated ABPM device. | Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 76 participants were not evaluable at either the baseline or 6 month assessment. | Posted | Mean | Standard Deviation | mm Hg | Baseline and 6 months |
|
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| Secondary | Renal Artery Dissection or Perforation During the Procedure That Requires Stenting or Surgery | Posted | Number | participants | Duration of the procedure (average of 65 minutes) |
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| Secondary | Renal Artery Infarction or Embolus | Posted | Number | participants | Duration of the procedure (average of 65 minutes) |
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| Secondary | Cerebrovascular Accident (CVA) at Time of Procedure | Posted | Number | participants | Duration of the procedure (average of 65 minutes) |
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| Secondary | Myocardial Infarction at Time of Procedure | Posted | Number | participants | Duration of the procedure (average of 65 minutes) |
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| Secondary | Sudden Cardiac Death at Time of Procedure | Posted | Number | participants | Duration of the procedure (average of 65 minutes) |
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| Secondary | Angiographically-documented Renal Stenosis Requiring an Intervention | Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 22 participants were not evaluable. | Posted | Number | participants | 2 Years |
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| Secondary | Chronic Symptomatic Orthostatic Hypotension | Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 22 participants were not evaluable. | Posted | Number | participants | 2 Years |
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| Secondary | Hypertensive Emergency Necessitating Hospital Admission (Unrelated to Medication and/or Non-compliance) | Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 22 participants were not evaluable. | Posted | Number | participants | 2 Years |
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| Secondary | Reduction in Estimated Glomerular Filtration Rate (eGFR) >25% | Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 25 participants were not evaluable. | Posted | Number | participants | 2 Years |
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Adverse events were collect through the 2 year follow up visit.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Renal Denervation | All subjects who meet the inclusion criteria and are enrolled in this trial will be treated with the Vessix Renal Denervation System. | 69 | 146 | 70 | 146 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Access Site Infection | Surgical and medical procedures | Procedure Related |
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| Clot or Thrombus Formation | Surgical and medical procedures | Procedure Related |
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| Hematoma | Surgical and medical procedures | Procedure Related |
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| Other Vascular - Stenosis | Surgical and medical procedures | Device Related/Procedure Related |
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| Pseudoaneurysm | Surgical and medical procedures | Procedure Related |
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| Other - Flank Pain | Surgical and medical procedures | Procedure Related |
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| Other - Digestive (vomiting) | Surgical and medical procedures | Procedure Related |
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| Other - Hypertensive Crisis | Surgical and medical procedures | Device Related/Procedure Related |
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| Other Cardiac - Hypertensive episode | Surgical and medical procedures | Device Related |
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| Acute Occlusion/Vessel Closure | Surgical and medical procedures |
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| Stent Required | Surgical and medical procedures |
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| Other Vascular - Carotid Stenosis | Vascular disorders |
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| Renal Insufficiency | Renal and urinary disorders |
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| Renal Failure | Renal and urinary disorders |
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| Myocardial Infarction | Cardiac disorders |
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| Other Renal - Renal Calcification | Vascular disorders |
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| Pneumonia | Respiratory, thoracic and mediastinal disorders |
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| Other Pulmonary | Respiratory, thoracic and mediastinal disorders |
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| Other Infectious/Inflammatory | Infections and infestations |
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| Stroke | Vascular disorders |
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| Congestive Heart Failure | Cardiac disorders |
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| Other Neurological | General disorders |
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| Unanticipated Adverse Events - Prolapsis Uteri | Reproductive system and breast disorders |
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| Other Cardiac - Chest Pain/Angina | Cardiac disorders |
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| Other - Hypertension | Renal and urinary disorders |
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| Other Cardiac - Fibrillation | Cardiac disorders |
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| Other Cardiac - Tachycardia | Cardiac disorders |
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| Other - Inflammation/Infection | Infections and infestations |
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| Other - Thoracic/Abdominal Pain | General disorders |
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| Other - Hernia | General disorders |
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| Other - Gastrointestinal/Rectal | Gastrointestinal disorders |
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| Other - Skeletal/Connective Tissue | Musculoskeletal and connective tissue disorders |
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| Other - Deconditioning post medical illness | General disorders |
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| Other - Dementia | General disorders |
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| Other - Diabetes | Metabolism and nutrition disorders |
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| Other - Elective Surgery | Surgical and medical procedures |
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| Other - Priapismus | Reproductive system and breast disorders |
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| Other - Limb oedema/ Ulceration | Vascular disorders |
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| Other - Coronary Sub-Occlusion | Vascular disorders |
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| Other - Nausea | General disorders |
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| Other - Overdose | General disorders |
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| Other - Prostate Carcinoma | Reproductive system and breast disorders |
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| Other - Sleep Apnoea | Respiratory, thoracic and mediastinal disorders |
| |||
| Other - Suicide Ideation | Psychiatric disorders |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Access Site Complications | Skin and subcutaneous tissue disorders | Procedure Related |
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| Pain | General disorders | Procedure Related |
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| Hematoma | Skin and subcutaneous tissue disorders | Procedure Related |
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| Anaesthesia Related - Nausea/Vomiting | General disorders | Procedure Related |
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| Reduced Kidney Function | Renal and urinary disorders | Device Related |
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| Dizziness | General disorders | Potentially Related to Device and/or Procedure |
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| Hypertension | General disorders | Potentially Related to Device and/or Procedure |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Angela Schutt, Clinical Trial Manager | Boston Scientific | 763-494-2166 | angela.schutt@bsci.com |
| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| Belgium |
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| Australia |
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| France |
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| Switzerland |
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| Germany |
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| Subjects on 3 medications |
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| Subjects on 2 medications |
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