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

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)

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.

Study Overview

• Status: Recruiting
• Conditions: AF - Atrial Fibrillation; HTN-Hypertension
• Intervention / Treatment: Other: Pulmonary vein isolation; Other: Renal Denervation operation

• Study Type: Interventional
• Enrollment (Estimated): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Fujian
    • Xiamen, Fujian, China, 361003
      • Recruiting
      • the first affiliated hopital of Xiamen University
      • Contact: Ziguan Zhang; Phone Number: +8618750227289; Email: 116504153@qq.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Sham Comparator: PVI alone; Participants only experience PVI operations	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.
Experimental: PVI and RDN; Participants experience both PVI and RDN operations	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.; 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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: The First Affiliated Hospital of Xiamen University

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2023
• Primary Completion (Estimated): April 30, 2026
• Study Completion (Estimated): April 30, 2028

Study Registration Dates

• First Submitted: April 4, 2023
• First Submitted That Met QC Criteria: April 24, 2023
• First Posted (Actual): May 3, 2023

Study Record Updates

• Last Update Posted (Actual): March 13, 2024
• Last Update Submitted That Met QC Criteria: March 11, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Hypertension (HTN); Atrial Fibrillation (AF); Pulmonary Vein Isolation (PVI); Renal Denervation (RDN)
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arrhythmias, Cardiac; Hypertension; Atrial Fibrillation
• Other Study ID Numbers: 2022-RDN and PVI

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No