None listed
Conditions
Interventions
Medical Device, Procedure/Surgery : The HyperQure RDN System consists of a generator that generates RF(Radiofrequency) energy and a Laparoscopic Instrument that delivers the RF energy generated by the
Sponsors
DeepQure
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: A subject can only participate in this clinical trial if they meet all of the following criteria: 1. Adult aged 19 to less than 80 2. Patient with essential hypertension *Defined as uncontrolled hypertension (blood pressure not controlled despite appropriate lifestyle modifications—such as reduced sodium intake, healthy diet, weight reduction, moderation of alcohol intake, smoking cessation, exercise, and stress management—and =3 months of antihypertensive therapy, as well as failure to achieve the target office BP =140/90 mmHg after =3 months of Step 2 dual full-dose combination therapy according to the 2020 ISH Global Hypertension Practice Guidelines, and who cannot proceed to Step 3 due to adverse effects or intolerance) or resistant hypertension. 3. Patient with recurrent atrial fibrillation* after catheter ablation *Defined as recurrent atrial fibrillation confirmed at least 3 months after undergoing catheter ablation—regardless of the ablation modality used, including radiofrequency ablation (RFA), pulsed field ablation (PFA), or cryoballoon ablation and also defined as an episode lasting at least 10 seconds, confirmed either by a standard 12-lead electrocardiogram (ECG), 24-hour Holter monitoring, or other comparable long-term ECG monitoring. 4. Individuals with an atrial arrhythmia burden of =1% and <100%, as determined by a 24-hour Holter monitor or patch-type ECG performed within 1 year prior to the screening date. 5. A person who meets all of the following blood pressure criteria ? Office systolic blood pressure (SBP) = 140 mmHg ? Office diastolic blood pressure (DBP) = 90 mmHg ? Daytime ambulatory systolic blood pressure (ASBP) = 135 mmHg 6. A person who voluntarily participates in this clinical trial and provides written consent through the Subject Information and Informed Consent Form 7. A person who is willing to comply with the clinical trial protocol
Exclusion criteria
Exclusion criteria: A subject who falls under any of the following cannot participate in this clinical trial: 1. A person confirmed to have permanent atrial fibrillation 2. A person with the left ventricular ejection fraction (LVEF) less than 35% based on the echocardiography conducted within 1 year prior to the day of screening 3. A person with surgical history, other than catheter ablation, for treatment of atrial fibrillation 4. A person confirmed to have refused implantation of an implantable loop recorder (ILR) 5. A person on one or more of the following medications as of the day of screening: ? A person on an antiarrhythmic medication for treatment of arrhythmia other than atrial fibrillation and is anticipated to change the medications within 3 months prior to or after RDN (however, a person who is on a stable dose without a change of the medication for 3 months prior to and after RDN can be enrolled) ? Oral anticoagulant for prevention and treatment of thromboembolism or cardio-cerebrovascular disease other than atrial fibrillation (however, the person can be enrolled if they have received confirmation that a short-term interruption of the oral anticoagulant is acceptable by the department, e.g., neurology, that prescribed the oral anticoagulant) ? Warfarin for prevention of thromboembolism ? Sympathomimetic medications affecting hypertension 6. A person confirmed to have one or more of the following anatomical findings that are not suitable for RDN based on the renal CT angiography conducted on the day of screening: ? Presence of atheroma or renal artery stent within 5 mm from the planned RDN application site ? Presence of stenosis of 50% or more in all renal vessels to which RDN is applicable combined ? Inapplicability of RDN in both renal arteries in the opinion of the investigator 7. A person confirmed to have one or more of the following medical, surgical or procedural histories that are not suitable for RDN: ? Polycystic kidney disease ? Atrophic kidney ? Fibromuscular dysplasia (FMD)5 ? Dialysis due to end-stage renal disease ? Stent insertion into the renal artery within 3 months from the day of screening5,7 ? History of any surgery conducted on both kidneys except intrarenal endoscopic procedure conducted through the urethra (e.g., renal denervation, kidney transplantation), 8. A person confirmed to have one or more of the following comorbid conditions or surgical or procedural histories that are not suitable for retroperitoneal approach required for RDN: ? Morbid obesity (body mass index (BMI) > 40 kg/m2) ? Inflammation in the retroperitoneal area ? Fibrosis in the retroperitoneal area ? History of surgery conducted with retroperitoneal approach 9. A person confirmed to have one or more of the following medical histories: ? Primary pulmonary hypertension ? Secondary hypertension ? Cardiovascular disease within 3 months from the day of screening (e.g., myocardial infarction, stable?unstable angina, acute heart failure (New York Heart Association (NYHA) classification III to IV), transient ischemic attack, cerebrovascular accident such as subarachnoidal hemorrhage or cerebral embolism) ? Type 1 diabetes mellitus or uncontrolled type 2 diabetes mellitus* * Uncontrolled type 2 diabetes mellitus: HbA1c = 9.0% ? Peptic ulcer or gastrointestinal bleeding within 6 months from the day of screening ? A person with unresolved drug or alcohol dependency who lacks the ability to understand and follow the instructions required for the clinical tria
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ?Change of AF/AFL/AT burden (%) from the baseline* at Month 6 after the RDN | — |
Secondary
| Measure | Time frame |
|---|---|
| ? Change of AF/AFL/AT burden (%) from the baseline* at Month 1, 3, and 12 after the RDN;? Change of AF burden (%) from the baseline* at Month 1, 3, 6, and 12 after the RDN;? Change of AF/AFL/AT burden (min/day) from the baseline* at Month 1, 3, 6, and 12 after the RDN;? Change of AF burden (min/day) from the baseline* at Month 1, 3, 6, and 12 after the RDN;? Change of AF/AFL/AT burden (% and min/day) from the baseline during the blanking period;? Change of AF burden (% and min/day) from the baseline during the blanking period;? Change of AFEQT (atrial fibrillation effect on quality-of-life) score (point) from the baseline* at Month 3, 6, and 12 after the surgery;? Change of EQ-5D-5L (EuroQol-5 Dimension-5 Level) from the baseline* at Month 3, 6, and 12 after the RDN;? Change of 24-h ASBP and ADBP (mmHg) from the baseline** at Month 3, 6, and 12 after the RDN;? Change of daytime ASBP and ADBP (mmHg) from the baseline** at Month 3, 6, and 12 after the RDN;? Change of nighttime ASBP and ADBP (mmHg) from the baseline** at Month 3, 6, and 12 after the RDN;? Change of office SBP and DBP (mmHg) from the baseline** at Month 1, 3, 6, and 12 after the RDN;? Proportion (%) of achieving target office SBP < 140 mmHg at Month 1, 3, 6, and 12 after the RDN;? Use of antihypertensive medication;? Use of antiarrhythmic medication;? Proportion (%) of applying rescue therapy (related to AF and blood pressure) after the RDN;Change in the number of atrial arrhythmia symptom occurrences;? Major adverse event (MAE) occurring at Month 1, 3, 6, and 12 after the RDN;? Adverse event occurring at Month 1, 3, 6, and 12 after the RDN;? Surgical procedure-related adverse event occurring at Month 1 after the RDN;? Vital signs (heart rate), laboratory test | — |
Countries
Korea, Republic of
Contacts
Public ContactSeil Oh
Seoul National University Hospital
Outcome results
None listed