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| Name | Class |
|---|---|
| Medtronic - MITG | INDUSTRY |
| Meditrial Europe Ltd. | INDUSTRY |
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The Covidien OneShotâ„¢ ablation system use is to deliver low-level radio frequency (RF) energy through the wall of the renal artery to denervate the human kidney.
Unique to the OneShotâ„¢ ablation system is the ability to deliver the desired helical treatment pattern for optimal Renal Denervation (RDN) with a single balloon based-treatment, eliminating user variance inherent in the currently available point-by-point approach. In addition, technological improvements have been incorporated. The OneShotâ„¢ RF generator has a touchscreen, user friendly interface; catheter advancement is made safer with the use of a guidewire; two radiopaque markers on the catheter enable more precise device positioning; and the irrigated catheter tip reduces the risk of overheating and clot formation during RF delivery. By offering a more reliable single treatment approach, coupled with enhanced ease-of use and reduced procedure times, this technology has the potential to significantly expand clinical adoption of catheter-based renal sympathetic denervation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rapid Renal Denervation | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Covidien OneShotâ„¢ System | Device | Placed percutaneously, the OneShotâ„¢ balloon catheter is advanced into the renal artery using a routine femoral approach in a cardiac catheterization laboratory setting. RF is applied with pre-programmed time and intensity in each of the renal arteries. |
| Measure | Description | Time Frame |
|---|---|---|
| Acute Procedural Safety | Acute Procedural Safety, defined as the overall rate of Serious Adverse Events (SAE's) and adverse device effects at discharge:
| One Week |
| Measure | Description | Time Frame |
|---|---|---|
| Chronic Procedural Safety | Chronic Procedural Safety, defined as the overall rate of Serious Adverse Events and Adverse Device Effects at 6 months | 6 months |
| Renal Denervation Procedure Effectiveness |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| W.A.L. Tonino, MD | Department of Cardiology, Catherina Hospital, Eindhoven, The Netherlands | Principal Investigator |
| Stefan Verheye, MD | Department of Interventional Cardiology, Middelheim Hospital, Antwerp, Belgium | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Middelheim Hospital | Antwerp | Belgium | ||||
| Ziekenhuis Oost--Limburg |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25452198 | Derived | Verheye S, Ormiston J, Bergmann MW, Sievert H, Schwindt A, Werner N, Vogel B, Colombo A. Twelve-month results of the rapid renal sympathetic denervation for resistant hypertension using the OneShotTM ablation system (RAPID) study. EuroIntervention. 2015 Feb;10(10):1221-9. doi: 10.4244/EIJY14M12_02. |
| Label | URL |
|---|---|
| Covidien (manufacturer) | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Rapid Renal Denervation | Covidien OneShotâ„¢ System: Placed percutaneously, the OneShotâ„¢ balloon catheter is advanced into the renal artery using a routine femoral approach in a cardiac catheterization laboratory setting. Radiofrequency (RF) is applied with pre-programmed time and intensity in each of the renal arteries. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Rapid Renal Denervation | Covidien OneShotâ„¢ System: Placed percutaneously, the OneShotâ„¢ balloon catheter is advanced into the renal artery using a routine femoral approach in a cardiac catheterization laboratory setting. RF is applied with pre-programmed time and intensity in each of the renal arteries. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Acute Procedural Safety | Acute Procedural Safety, defined as the overall rate of Serious Adverse Events (SAE's) and adverse device effects at discharge:
| Posted | Number | percentage of participants | One Week |
|
|
12 months
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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 | Rapid Renal Denervation | Covidien OneShotâ„¢ System: Placed percutaneously, the OneShotâ„¢ balloon catheter is advanced into the renal artery using a routine femoral approach in a cardiac catheterization laboratory setting. RF is applied with pre-programmed time and intensity in each of the renal arteries. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Blood and lymphatic system disorders | Blood and lymphatic system disorders | MedDRA (14.7) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Blood and lymphatic system disorders | Blood and lymphatic system disorders | MedDRA (14.7) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Stephanie Cihlar | Medtronic | 763-398-7932 | stephanie.a.cihlar@medtronic.com |
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| ID | Term |
|---|---|
| C563514 | Hypertension Resistant to Conventional Therapy |
| D006973 | Hypertension |
| D007674 | Kidney Diseases |
| D007676 | Kidney Failure, Chronic |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D014570 | Urologic Diseases |
| D051436 | Renal Insufficiency, Chronic |
| D051437 | Renal Insufficiency |
| ID | Term |
|---|---|
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
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|
|
Procedural Effectiveness, defined as rate of Office Systolic Blood Pressure (SBP) reduction > 10 mmHg at 6 months compared to baseline
| From baseline to 6 months |
| Genk |
| 3600 |
| Belgium |
| Universitatklinikum | Bonn | Germany |
| Cardiovascular Center Sankt Katharinen | Frankfurt | Germany |
| Asklepios Klinik St. Georg | Hamburg | Germany |
| Univ. Medical Klinik III | Heidelberg | Germany |
| Franziskus Hospital | Münster | Germany |
| Hospital San Raffaele | Milan | Italy |
| Centre Hospitalier De Luxembourg | Luxembourg | L-1210 | Luxembourg |
| Santa Catharina Hospital | Eindhoven | Netherlands |
| St. Antonius Ziekenhuis | Nieuwegein | Netherlands |
| Erasmus MC Thoraxcenter | Rotterdam | Netherlands |
| UMC Universitair Medisch Centrum | Utrecht | Netherlands |
| Mercy Angiography Unit | Auckland | New Zealand |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Participants |
|
|
| Secondary | Chronic Procedural Safety | Chronic Procedural Safety, defined as the overall rate of Serious Adverse Events and Adverse Device Effects at 6 months | Posted | Number | percentage of participants | 6 months |
|
|
|
| Secondary | Renal Denervation Procedure Effectiveness | Procedural Effectiveness, defined as rate of Office Systolic Blood Pressure (SBP) reduction > 10 mmHg at 6 months compared to baseline | Posted | Number | percentage of participants | From baseline to 6 months |
|
|
|
| 16 |
| 50 |
| 32 |
| 50 |
| Cardiac disorders | Cardiac disorders | MedDRA (14.7) | Systematic Assessment |
|
| General disorders and administrative site conditions | General disorders | MedDRA (14.7) | Systematic Assessment |
|
| Infections and infestations | Infections and infestations | MedDRA (14.7) | Systematic Assessment |
|
| Injury, poisoning and procedural complications | Injury, poisoning and procedural complications | MedDRA (14.7) | Systematic Assessment |
|
| Musculoskeletal and connective tissue disorders | Musculoskeletal and connective tissue disorders | MedDRA (14.7) | Systematic Assessment |
|
| Nervous system disorders | Nervous system disorders | MedDRA (14.7) | Systematic Assessment |
|
| Respiratory, thoracic and mediastinal disorders | Respiratory, thoracic and mediastinal disorders | MedDRA (14.7) | Systematic Assessment |
|
| Skin and subcutaneous tissue disorders | Skin and subcutaneous tissue disorders | MedDRA (14.7) | Systematic Assessment |
|
| Surgical and medical procedures | Surgical and medical procedures | MedDRA (14.7) | Systematic Assessment |
|
| Vascular disorders | Vascular disorders | MedDRA (14.7) | Systematic Assessment |
|
| Cardiac disorders | Cardiac disorders | MedDRA (14.7) | Systematic Assessment |
|
| Gastrointestinal disorders | Gastrointestinal disorders | MedDRA (14.7) | Systematic Assessment |
|
| General disorders and administrative site conditions | General disorders | MedDRA (14.7) | Systematic Assessment |
|
| Infections and infestations | Infections and infestations | MedDRA (14.7) | Systematic Assessment |
|
| Injury, poisoning and procedural complications | Injury, poisoning and procedural complications | MedDRA (14.7) | Systematic Assessment |
|
| Investigations | Investigations | MedDRA (14.7) | Systematic Assessment |
|
| Metabolism and nutrition disorders | Metabolism and nutrition disorders | MedDRA (14.7) | Systematic Assessment |
|
| Musculoskeletal and connective tissue disorders | Musculoskeletal and connective tissue disorders | MedDRA (14.7) | Systematic Assessment |
|
| Nervous system disorders | Nervous system disorders | MedDRA (14.7) | Systematic Assessment |
|
| Psychiatric disorders | Psychiatric disorders | MedDRA (14.7) | Systematic Assessment |
|
| Renal and urinary disorders | Renal and urinary disorders | MedDRA (14.7) | Systematic Assessment |
|
| Reproductive system and breast disorders | Reproductive system and breast disorders | MedDRA (14.7) | Systematic Assessment |
|
| Respiratory, thoracic and mediastinal disorders | Respiratory, thoracic and mediastinal disorders | MedDRA (14.7) | Systematic Assessment |
|
| Vascular disorders | Vascular disorders | MedDRA (14.7) | Systematic Assessment |
|
There is an agreement between the Principal Investigator and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results without permission of the sponsor.
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |