Clinical trial NCT05841615: Pulmonary Vein Isolation (PVI) Combined With Renal Denervation (RDN) in Atrial Fibrillation (AF) and Hypertension (HTN)
Official title: 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)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: AF - Atrial Fibrillation
HTN-Hypertension
Keywords: Pulmonary Vein Isolation (PVI)
Renal Denervation (RDN)
Atrial Fibrillation (AF)
Hypertension (HTN)
Lead sponsor: The First Affiliated Hospital of Xiamen University
Sponsor class: OTHER
First posted: 2023-05-03
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Malignant end point event 1
timeFrame: within 2 years post operation
measure: Malignant end point event 2
timeFrame: within 2 years post operation
measure: Malignant end point event 3
timeFrame: within 2 years post operation
measure: Malignant end point event 4
timeFrame: within 2 years post operation
Secondary outcomes:
measure: Complex end point event 1
timeFrame: within 2 years post operation
measure: Complex end point event 2
timeFrame: within 2 years post operation
measure: Complex end point event 3
timeFrame: within 2 years post operation
measure: Complex end point event 4
timeFrame: within 2 years post operation
measure: Complex end point event 5
timeFrame: within 2 years post operation
measure: Complex end point event 6
timeFrame: within 2 years post operation
measure: Complex end point event 7
timeFrame: within 2 years post operation
measure: Complex end point event 8
timeFrame: within 2 years post operation
measure: Complex end point event 9
timeFrame: within 2 years post operation
measure: Complex end point event 10
timeFrame: within 2 years post operation
Other outcomes:
Locations:
city: Xiamen
country: China
facility: the first affiliated hopital of Xiamen University
state: Fujian
Study officials:
References: