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

AF - Atrial Fibrillation Clinical Trial

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05841615
• Other study ID #: 2022-RDN and PVI
• Status: Recruiting
• Phase: N/A
• Start date: September 1, 2023
• Est. completion date: April 30, 2028

Study information

• Verified date: March 2024
• Source: The First Affiliated Hospital of Xiamen University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: April 30, 2028
• Est. primary completion date: April 30, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• AF - Atrial Fibrillation
• Atrial Fibrillation
• Hypertension

Intervention

Other:
• 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
• 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.

Locations

Country	Name	City	State
China	the first affiliated hopital of Xiamen University	Xiamen	Fujian

Sponsors (1)

Lead Sponsor	Collaborator
The First Affiliated Hospital of Xiamen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Malignant end point event 1	Fatal and nonfatal stroke	within 2 years post operation
Primary	Malignant end point event 2	cerebral hemorrhage	within 2 years post operation
Primary	Malignant end point event 3	acute myocardial infarction	within 2 years post operation
Primary	Malignant end point event 4	cardiovascular death	within 2 years post operation
Secondary	Complex end point event 1	Hospitalization for heart failure	within 2 years post operation
Secondary	Complex end point event 2	elevation of blood pressure(mmHg, upper arm blood pressure electronic monitor)	within 2 years post operation
Secondary	Complex end point event 3	left ventricular hypertrophy(mm, by Cardiac color ultrasound)	within 2 years post operation
Secondary	Complex end point event 4	coronary revascularization(by coronary arteriography)	within 2 years post operation
Secondary	Complex end point event 5	transient ischemic attack	within 2 years post operation
Secondary	Complex end point event 6	renal insufficiency (eGFR ml/min, by ECT);	within 2 years post operation
Secondary	Complex end point event 7	renal artery stenosis(by renal arteriography)	within 2 years post operation
Secondary	Complex end point event 8	proteinuria(mg/L, PRM assay)	within 2 years post operation
Secondary	Complex end point event 9	the recurrence rate of atrial fibrillation	within 2 years post operation
Secondary	Complex end point event 10	the control rate of blood pressure	within 2 years post operation