Renal Sympathetic Denervation in patients with therapy-resistant Catecholamine Polymorphic Ventricular Tachycardia (CPVT) and Long QT Syndrome (LQTS) * RESIDENT Study
- Conditions
- irregular heartbeatventricular arrhythmia10007521
- Registration Number
- NL-OMON41010
- Lead Sponsor
- Academisch Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Withdrawn
- Sex
- Not specified
- Target Recruitment
- 20
Inclusion Criteria
1. Subjects who have provided written informed consent;
2. Subjects who are * 18 years of age;
3. Subjects who in the last year have had at least 1 event related to therapy refractory CPVT or LQTS
4. Subjects with a eGFR * 45 ml/min per 1.73m2;
5. Subjects who are willing and able to comply with all study procedures. ;Anatomical Inclusion Criteria
1. Subjects with or without an accessory renal artery who have a main renal artery diameter of * 3.5 mm and * 7.0 mm for each of their kidneys
2. Subjects who have a main renal artery without significant stenosis (defined as < 30%)
3. Subjects who have a renal artery length of * 15 mm.
1. Subjects who are contraindicated for intravascular contrast material;
2. Subjects who are contraindicated for anticoagulation medications (heparin, aspirin, Angiomax, etc.), analgesic medications (morphine, fentanyl, etc.), anxiolytic medications (alprazolam, lorazepam, diazepam, etc.) or other medications required for an interventional procedure;
3. Subjects with known bleeding or hyper-coagulation disorders;
4. Subjects who have type 1 diabetes mellitus;
5. Subjects who have experienced a myocardial infarction, unstable angina pectoris, uncompensated heart failure, or a cerebrovascular accident within six (6) months prior to the screening visit, or have widespread atherosclerosis, with documented intravascular thrombosis or unstable plaques;
6. Subjects who have planned percutaneous vascular or surgical intervention for any reason within the next six (6) months;
7. Subjects who have hemodynamically significant valvular heart disease for which reduction of blood pressure would be considered hazardous;
8. Subjects who have any serious medical condition, which in the opinion of the investigator, may adversely affect patient safety or the efficacy of the procedure in the study (i.e., patients with clinically significant peripheral vascular disease, abdominal aortic aneurysm, bleeding disorders);
9. Female participants of childbearing potential must have a negative serum or urine human chorionic gonadotropin (hCG) pregnancy test prior to the procedure;
10. Subjects who have a known, unresolved history of drug use or alcohol abuse/dependency;
11. Subjects who are currently enrolled in any investigational study wherein patient participation has not been completed;
12. Subjects who, for any reason, may not be able to understand or comply with instructions. ;Anatomical Exclusion Criteria
1. Subjects with only one kidney;
2. Subjects with prior renal denervation procedure;
3. Subjects with prior intervention to right or left renal artery;
4. Subjects with renal artery stenosis as defined by * 30% stenosis confirmed by angiography with two (2) orthogonal views with selective catheterization;
5. Subjects with iliac stenosis requiring intervention at time of procedure and/or within the next six (6) months;
6. Subjects with severe femoral, renal, iliac or aortic calcification that may cause a potential complication at the time of the procedure;
7. Subjects in which the physician is unable to cannulate the renal artery;
8. Subjects in which the physician is unable to access the femoral artery by percutaneous means.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Primary endpoint in this study will be cardiac events after renal denervation,<br /><br>defined as:<br /><br>(1) an appropriate ICD shock, defined as an ICD shock on ventricular<br /><br>fibrillation or ventricular tachycardia<br /><br>(2) arrhythmic syncope, seizures, or aborted cardiac arrest(3) number of ventricular extra systoles (VES) in CPVT patients<br /><br>(3) malignant non-sustained VT (NSVT)</p><br>
- Secondary Outcome Measures
Name Time Method <p>n.a.</p><br>