The OneShotTM System procedure is designed to provide the anatomical and physiologic benefits of catheter-based RDN at lesser risk to the subject, due to a reduction of complexity of the procedure and design improvements intended to enhance…
ID
Source
Brief title
Condition
- Cardiac disorders, signs and symptoms NEC
- Vascular hypertensive disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
1. RDN Acute Safety, defined as overall rate of Serious Adverse Events (SAE*s)
and adverse device effects at discharge:
(a) SAE*s related to groin and vascular access complications, and
(b) SAE*s related to renal artery injury
2. RDN Chronic Safety, defined as the overall rate of Serious Adverse Events
and Adverse Device Effects at 6 months
3. RDN Effectiveness, defined as Office Systolic Blood Pressure (SBP) reduction
>10 mmHg at 6 months compared to baseline
Secondary outcome
1. Procedure time
2. Fluoroscopy time
3. Rate of Office SBP reduction >=10mmHg at 12, 24 and 36 months compared to
baseline.
Background summary
Renal Denervation (RDN) is an emerging therapy intended to induce blood
pressure-lowering on the basis of the ablation of efferent sympathetic and
sensory afferent fibers of the renal nerves. Catheter based RDN is performed by
commercially available Ardian Symplicity System. This is a single electrode
catheter that is used to create multiple discrete, intentionally spaced
ablation lesions. The operator progressively delivers 4-6 radiofrequency (RF)
ablation treatment at points distributed circumferentially along the length of
the renal artery (point-by-point ablation). The procedure therefore requires
both 90° rotation and pull-back of the catheter between each treatment.
Clinical studies have shown effectiveness and safety in patients with
uncontrolled hypertension, but the procedure is complex, lengthy and operator
dependent.
Study objective
The OneShotTM System procedure is designed to provide the anatomical and
physiologic benefits of catheter-based RDN at lesser risk to the subject, due
to a reduction of complexity of the procedure and design improvements intended
to enhance repeatability and reproducibility.
To collect information on clinical outcomes and safety in patients requiring
RDN for the treatment of resistant hypertension treated with the OneShotTM
System.
Study design
Multi-center, prospective, non-randomized, single arm clinical trial with
intra-patient comparisons.
Intervention
Placed percutaneously, the OneShotTM 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.
Study burden and risks
The OneShotTM Ablation System may involve other risks and side effects that are
as yet unknown.
The possible risks for this procedure include:
• Injury to the blood vessels or the kidneys
• Bleeding or the development of blood clots.
• Aneurysm
• Vessel thrombosis
• Infection in the groin or infection of the blood.
• Blockage of blood supply to vital organs by the catheter.
• Vessel dissection
• Hemorrhage,
• Vessel spasm
• Pulmonary embolism ,
• Perforation of the renal artery by the catheter
• Heart rhythm disturbances, such as a slowed heart rate
• Perforation of the vessel
• Heart Attack
• Pseudoaneurysm
• Stroke
• Kidney damage
• Skin burn and pain
• Hematoma
• Death
• Low blood pressure
• Allergic reactions to x-ray dye, local anesthesia and medication required for
sedation during the procedure
Based on various studies with a standard renal denervation system in
approximately 350 patients the following complications were observed:
* damage to the blood vessels of the kidney in approximately 1% of patients
* blood clots leading to heart attack or stroke in 1-2%
* extended stay in hospital for 1-2% of patients
* pseudoaneurysm groin artery in approximately 2% of patients
* (temporarily) low blood pressure in 1-2% of patients
* urinary tract infection in 1-2% of the patients
* placement of a stent in 1-2% of patients
* arrhythmias during the procedure in 2-4%
Covidien, Camden Avenue, Suite A 745
Campbell CA 95008
US
Covidien, Camden Avenue, Suite A 745
Campbell CA 95008
US
Listed location countries
Age
Inclusion criteria
1. Systolic blood pressure >= 160 mmHg despite treatment with a regimen of 3 or more anti-hypertensive medications taken at optimal dose amounts including a diuretic and that has been stable for two 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 then 4mm or greater then 7mm.
2. Length of treatable segment of renal artery less than 20mm.
3. Renal arterial abnormalities including severe renal artery stenosis, previous renal stenting or angioplasty.
4. End-stage renal disease requiring dialysis or renal transplant
5. eGFR < 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
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL39366.060.12 |