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

NCT ID: NCT05841615

Last Updated: 2024-03-13

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-09-01
• Study Completion Date: 2028-04-30

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.

Conditions

AF - Atrial Fibrillation; HTN-Hypertension

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

PVI alone

Participants only experience PVI operations

Group Type: SHAM_COMPARATOR

Pulmonary vein isolation

Intervention Type: 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.

PVI and RDN

Participants experience both PVI and RDN operations

Group Type: EXPERIMENTAL

Renal Denervation operation

Intervention Type: 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

Pulmonary vein isolation

Intervention Type: 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.

Interventions

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

Intervention Type: OTHER

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.

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The First Affiliated Hospital of Xiamen University

OTHER

Sponsor Role: lead

Responsible Party

Zhengrong Huang

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

the first affiliated hopital of Xiamen University

Xiamen, Fujian, China

Site Status: RECRUITING

Countries

China

Facility Contacts

Ziguan Zhang

Role: primary

116504153@qq.com

+8618750227289

Other Identifiers

2022-RDN and PVI

Identifier Type: -

Identifier Source: org_study_id