Pulmonary Vein Isolation (PVI) Combined With Renal Denervation (RDN) in Atrial Fibrillation (AF) and Hypertension (HTN)

Study Overview
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Brief Summary
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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.

Official Title
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Evaluation of the Safety and Efficacy of Pulmonary Vein Isolation (PVI) Combined With Renal Denervation (RDN) in Patients With Atrial Fibrillation (AF) and Hypertension (HTN)

Conditions
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AF - Atrial Fibrillation, HTN-Hypertension

Intervention / Treatment
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* Other: Renal Denervation operation
* Other: Pulmonary vein isolation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sham Comparator: PVI alone<br>Participants only experience PVI operations | Other: Pulmonary vein isolation<br>* 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.<br>|
| Experimental: PVI and RDN<br>Participants experience both PVI and RDN operations | Other: Renal Denervation operation<br>* 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<br>Other: Pulmonary vein isolation<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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) | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pulmonary Vein Isolation (PVI), Renal Denervation (RDN), Atrial Fibrillation (AF), Hypertension (HTN)