Hypertension, Resistant to Conventional Therapy
Conditions
Keywords
Hypertension, Kidney Diseases, Kidney Failure, Chronic, Vascular Diseases, Cardiovascular Diseases, Urologic Diseases, Renal Insufficiency, Chronic, Renal Insufficiency
Brief summary
The Covidien OneShot™ ablation system use is to deliver low-level radio frequency (RF) energy through the wall of the renal artery to denervate the human kidney.
Detailed description
Unique to the OneShot™ 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 OneShot™ 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.
Interventions
DEVICECovidien OneShot™ System
Placed percutaneously, the OneShot™ 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.
Sponsors
Medtronic - MITG
Meditrial Europe Ltd.
Medtronic Endovascular
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
1. Systolic blood pressure ≥ 160 mmHg despite treatment with a regimen of 3 or more anti-hypertensive medications that includes a diuretic and that has been stable for 2 weeks prior to screening. 2. Age 18-85 years. 3. Able to provide informed consent and comply with follow-up visits.
Exclusion criteria
1. Diameter of left or right renal artery less than 4 mm or greater than 7mm. 2. Length of target segment of left or right renal artery less than 20mm. 3. Other renal arterial abnormalities including severe renal artery stenosis, previous renal stenting or angioplasty. 4. End-stage renal disease requiring dialysis or renal transplant. 5. estimated Glomerular Filtration Rate \< 45 mL/min per 1.73 m2. 6. Type 1 diabetes mellitus. 7. Myocardial infarction, unstable angina, or cerebrovascular events within 6 months prior to screening. 8. Severe valvular heart disease for which reduction of blood pressure would be considered hazardous. 9. Bleeding disorder or refusing blood transfusions. 10. Pregnancy or breast feeding. 11. Peripheral vascular disease precluding catheter insertion. 12. Any serious medical condition, which in the opinion of the investigator, may adversely affect the safety or effectiveness of the participant or the study. 13. Current enrollment in another investigational drug or device Study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Acute Procedural Safety | One Week | Acute Procedural Safety, defined as the overall rate of Serious Adverse Events (SAE's) and adverse device effects at discharge: * SAE's related to groin and vascular access complications, and * SAE's related to renal artery injury. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Chronic Procedural Safety | 6 months | Chronic Procedural Safety, defined as the overall rate of Serious Adverse Events and Adverse Device Effects at 6 months |
| Renal Denervation Procedure Effectiveness | From baseline to 6 months | Procedural Effectiveness, defined as rate of Office Systolic Blood Pressure (SBP) reduction \> 10 mmHg at 6 months compared to baseline |
Countries
Belgium, Germany, Italy, Luxembourg, Netherlands, New Zealand
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Rapid Renal Denervation Covidien OneShot™ System: Placed percutaneously, the OneShot™ 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. | 50 |
| Total | 50 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 1 |
| Overall Study | Missed Visit | 4 |
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | Rapid Renal Denervation |
|---|---|
| Age, Continuous | 63.0 years STANDARD_DEVIATION 9.5 |
| Sex: Female, Male Female | 21 Participants |
| Sex: Female, Male Male | 29 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 32 / 50 |
| serious Total, serious adverse events | 16 / 50 |
Outcome results
Primary
Acute Procedural Safety
Acute Procedural Safety, defined as the overall rate of Serious Adverse Events (SAE's) and adverse device effects at discharge: * SAE's related to groin and vascular access complications, and * SAE's related to renal artery injury.
Time frame: One Week
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Rapid Renal Denervation | Acute Procedural Safety | 4 percentage of participants |
Secondary
Chronic Procedural Safety
Chronic Procedural Safety, defined as the overall rate of Serious Adverse Events and Adverse Device Effects at 6 months
Time frame: 6 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Rapid Renal Denervation | Chronic Procedural Safety | 6 percentage of participants |
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
Time frame: From baseline to 6 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Rapid Renal Denervation | Renal Denervation Procedure Effectiveness | 61.7 percentage of participants |