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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PVI alone | Sham Comparator | Participants only experience PVI operations |
|
| PVI and RDN | Experimental | Participants experience both PVI and RDN operations |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Renal Denervation operation | Other | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Malignant end point event 1 | Fatal and nonfatal stroke | within 2 years post operation |
| Malignant end point event 2 | cerebral hemorrhage | within 2 years post operation |
| Malignant end point event 3 | acute myocardial infarction | within 2 years post operation |
| Malignant end point event 4 | cardiovascular death | within 2 years post operation |
| Measure | Description | Time Frame |
|---|---|---|
| Complex end point event 1 | Hospitalization for heart failure | within 2 years post operation |
| Complex end point event 2 | elevation of blood pressure(mmHg, upper arm blood pressure electronic monitor) |
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Inclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| the first affiliated hopital of Xiamen University | Recruiting | Xiamen | Fujian | 361003 | China |
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| Pulmonary vein isolation | Other | 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. |
|
| within 2 years post operation |
| Complex end point event 3 | left ventricular hypertrophy(mm, by Cardiac color ultrasound) | within 2 years post operation |
| Complex end point event 4 | coronary revascularization(by coronary arteriography) | within 2 years post operation |
| Complex end point event 5 | transient ischemic attack | within 2 years post operation |
| Complex end point event 6 | renal insufficiency (eGFR ml/min, by ECT); | within 2 years post operation |
| Complex end point event 7 | renal artery stenosis(by renal arteriography) | within 2 years post operation |
| Complex end point event 8 | proteinuria(mg/L, PRM assay) | within 2 years post operation |
| Complex end point event 9 | the recurrence rate of atrial fibrillation | within 2 years post operation |
| Complex end point event 10 | the control rate of blood pressure | within 2 years post operation |
| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D014652 | Vascular Diseases |
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