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NCT Number: NCT05841615

Pulmonary Vein Isolation (PVI) Combined With Renal Denervation (RDN) in 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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

the first affiliated hopital of Xiamen University

Xiamen, Fujian, 361003, China

Location status: Recruiting

Location contact

Ziguan Zhang

CONTACT

[email protected]

+8618750227289

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

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.

Primary outcomes

  1. Malignant end point event 1

    Time frame: within 2 years post operation

    Fatal and nonfatal stroke

  2. Malignant end point event 2

    Time frame: within 2 years post operation

    cerebral hemorrhage

  3. Malignant end point event 3

    Time frame: within 2 years post operation

    acute myocardial infarction

  4. Malignant end point event 4

    Time frame: within 2 years post operation

    cardiovascular death

Secondary outcomes

  1. Complex end point event 1

    Time frame: within 2 years post operation

    Hospitalization for heart failure

  2. Complex end point event 2

    Time frame: within 2 years post operation

    elevation of blood pressure(mmHg, upper arm blood pressure electronic monitor)

  3. Complex end point event 3

    Time frame: within 2 years post operation

    left ventricular hypertrophy(mm, by Cardiac color ultrasound)

  4. Complex end point event 4

    Time frame: within 2 years post operation

    coronary revascularization(by coronary arteriography)

  5. Complex end point event 5

    Time frame: within 2 years post operation

    transient ischemic attack

  6. Complex end point event 6

    Time frame: within 2 years post operation

    renal insufficiency (eGFR ml/min, by ECT);

  7. Complex end point event 7

    Time frame: within 2 years post operation

    renal artery stenosis(by renal arteriography)

  8. Complex end point event 8

    Time frame: within 2 years post operation

    proteinuria(mg/L, PRM assay)

  9. Complex end point event 9

    Time frame: within 2 years post operation

    the recurrence rate of atrial fibrillation

  10. Complex end point event 10

    Time frame: within 2 years post operation

    the control rate of blood pressure

Sponsors and collaborators

Lead sponsor

The First Affiliated Hospital of Xiamen University

Other

Registry information

Official study 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)

Important dates

Study start
2023
Primary completion
2026
Study completion
2028
First posted
May 3, 2023
Registry last updated
Mar 13, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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