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

NCT05841615 | Recruiting

• 1 other identifier: 2022-RDN and PVI
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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

Keywords

Pulmonary Vein Isolation (PVI); Renal Denervation (RDN); Atrial Fibrillation (AF); Hypertension (HTN)

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (10)

• Complex end point event 1

  within 2 years post operation

• Complex end point event 2

  within 2 years post operation

• Complex end point event 3

  within 2 years post operation

• Complex end point event 4

  within 2 years post operation

• Complex end point event 5

  within 2 years post operation

Study Arms (2)

PVI alone

SHAM COMPARATOR

Participants only experience PVI operations

Other: Pulmonary vein isolation

PVI and RDN

EXPERIMENTAL

Participants experience both PVI and RDN operations

Other: Renal Denervation operation; Other: Pulmonary vein isolation

Interventions

Renal Denervation operation 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

PVI and RDN

Pulmonary vein isolation 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 alone; PVI and RDN

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \<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.

You may not qualify if:

• 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

Sponsors & Collaborators

• The First Affiliated Hospital of Xiamen University: lead

Study Sites (1)

the first affiliated hopital of Xiamen University

Xiamen, Fujian, 361003, China

RECRUITING

MeSH Terms

Conditions

Atrial Fibrillation; Hypertension

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Vascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 4, 2023
• First Posted: May 3, 2023
• Study Start: September 1, 2023
• Primary Completion: April 30, 2026
• Study Completion (Estimated): April 30, 2028
• Last Updated: March 13, 2024

Record last verified: 2024-03

Locations

CN (1)