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

Официальное название

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)

Обзор

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.

Вмешательства

• Другое Renal 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
• Другое Pulmonary 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.

Первичные конечные точки

• Malignant end point event 1 [Срок оценки: within 2 years post operation]
• Malignant end point event 2 [Срок оценки: within 2 years post operation]
• Malignant end point event 3 [Срок оценки: within 2 years post operation]
• Malignant end point event 4 [Срок оценки: within 2 years post operation]

Вторичные конечные точки (10)

• Complex end point event 1 [Срок оценки: within 2 years post operation]
• Complex end point event 2 [Срок оценки: within 2 years post operation]
• Complex end point event 3 [Срок оценки: within 2 years post operation]
• Complex end point event 4 [Срок оценки: within 2 years post operation]
• Complex end point event 5 [Срок оценки: within 2 years post operation]
• Complex end point event 6 [Срок оценки: within 2 years post operation]
• Complex end point event 7 [Срок оценки: within 2 years post operation]
• Complex end point event 8 [Срок оценки: within 2 years post operation]
• Complex end point event 9 [Срок оценки: within 2 years post operation]
• Complex end point event 10 [Срок оценки: within 2 years post operation]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• the first affiliated hopital of Xiamen University — Xiamen

Идентификаторы

NCT: NCT05841615 · 2022-RDN and PVI

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗