AF - Atrial Fibrillation, HTN-Hypertension
Conditions
Keywords
Pulmonary Vein Isolation (PVI), Renal Denervation (RDN), Atrial Fibrillation (AF), Hypertension (HTN)
Brief summary
The close relationship between the increase of sympathetic tension, AF, and HTN cannot be ignored. In addition, the significant failure rate of PVI (20-50%) in the treatment of AF makes it very necessary to explore the effect of RDN on AF. Therefore, this study aims to compare the effects and safety of PVI alone and PVI combined with RDN with AF combined with HTN, which will open a new chapter for PVI combined with RDN in the treatment of AF.
Interventions
OTHERRenal Denervation operation
RDN: Percutaneous renal artery sympathetic radiofrequency ablation for both sides. For each side, a total of 13 targets were ablated. The ablation power was 8W\ 12W for 40 seconds
OTHERPulmonary vein isolation
PVI: Pulmonary vein isolation was performed until the potential of each pulmonary vein disappeared under the guidance of the CARTO mapping system. Ablation of the top line and the bottom line of the left atrium was performed at the same time.
Sponsors
The First Affiliated Hospital of Xiamen University
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* 18\<age\<75years * clinic blood pressure≥140/90mmHg or 24-hour ambulatory blood pressure monitoring average blood pressure ≥135/85mmHg * Ecg diagnosis of atrial fibrillation ; * who signed informed consent and were approved by the Ethics Committee of the First Affiliated Hospital of Xiamen University.
Exclusion criteria
* pregnant women or lactating patients; * Patients who were unsuitable for ablation before surgery （unilateral or bilateral renal artery shape and structure were found： renal artery stenosis exceeding 50%, renal aneurysm, previous renal artery interventional surgery, renal artery malformation, renal artery diameter \< 4mm or length of treatable segment \< 20mm） * Patients who only have one kidney or have a history of kidney transplantation * Patients with a history of renal arterial intervention or renal denervation * identified secondary hypertension or Pseudo hypertension except for renal parenchymal hypertension; * malignant tumors or end-stage diseases; * Severe peripheral vascular disease, abdominal aortic aneurysm * whose left atrium is larger than 55mm * obvious bleeding tendency and blood system diseases; * Severe peripheral vascular disease, abdominal aortic aneurysm; * A history of the acute coronary syndrome within two weeks; * acute or severe systemic infection; * drug or alcohol dependence or refusal to sign informed consent. * Other conditions that are not suitable for PVI and RDN
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Malignant end point event 1 | within 2 years post operation | Fatal and nonfatal stroke |
| Malignant end point event 2 | within 2 years post operation | cerebral hemorrhage |
| Malignant end point event 3 | within 2 years post operation | acute myocardial infarction |
| Malignant end point event 4 | within 2 years post operation | cardiovascular death |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Complex end point event 5 | within 2 years post operation | transient ischemic attack |
| Complex end point event 6 | within 2 years post operation | renal insufficiency (eGFR ml/min, by ECT); |
| Complex end point event 7 | within 2 years post operation | renal artery stenosis(by renal arteriography) |
| Complex end point event 1 | within 2 years post operation | Hospitalization for heart failure |
| Complex end point event 9 | within 2 years post operation | the recurrence rate of atrial fibrillation |
| Complex end point event 10 | within 2 years post operation | the control rate of blood pressure |
| Complex end point event 8 | within 2 years post operation | proteinuria(mg/L, PRM assay) |
| Complex end point event 2 | within 2 years post operation | elevation of blood pressure(mmHg, upper arm blood pressure electronic monitor) |
| Complex end point event 3 | within 2 years post operation | left ventricular hypertrophy(mm, by Cardiac color ultrasound) |
| Complex end point event 4 | within 2 years post operation | coronary revascularization(by coronary arteriography) |
Countries
China
Outcome results
None listed