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Recruiting NCT05841615

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

No phase Interventional AF - Atrial Fibrillation HTN-Hypertension

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Renal Denervation operation, Pulmonary vein isolation.
Who it may be relevant to
Registry conditions: AF - Atrial Fibrillation, HTN-Hypertension. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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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)

Overview

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.

Interventions

  • 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
  • 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.

Primary outcome measures

  • Malignant end point event 1 [Time frame: within 2 years post operation]
  • Malignant end point event 2 [Time frame: within 2 years post operation]
  • Malignant end point event 3 [Time frame: within 2 years post operation]
  • Malignant end point event 4 [Time frame: within 2 years post operation]
Secondary outcome measures (10)
  • Complex end point event 1 [Time frame: within 2 years post operation]
  • Complex end point event 2 [Time frame: within 2 years post operation]
  • Complex end point event 3 [Time frame: within 2 years post operation]
  • Complex end point event 4 [Time frame: within 2 years post operation]
  • Complex end point event 5 [Time frame: within 2 years post operation]
  • Complex end point event 6 [Time frame: within 2 years post operation]
  • Complex end point event 7 [Time frame: within 2 years post operation]
  • Complex end point event 8 [Time frame: within 2 years post operation]
  • Complex end point event 9 [Time frame: within 2 years post operation]
  • Complex end point event 10 [Time frame: within 2 years post operation]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • the first affiliated hopital of Xiamen University — Xiamen

Identifiers

NCT: NCT05841615 · 2022-RDN and PVI

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗