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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorThe First Affiliated Hospital of Xiamen University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Renal Denervation operation

    Other intervention

    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 intervention

    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.

Treatment groups

120 Participants
are divided into 2 treatment groups
Group A: PVI aloneSham comparator 1 intervention
Group B: PVI and RDNExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Malignant end point event 1

Fatal and nonfatal stroke

Time frame
within 2 years post operation
2

Malignant end point event 2

cerebral hemorrhage

Time frame
within 2 years post operation
3

Malignant end point event 3

acute myocardial infarction

Time frame
within 2 years post operation
4

Malignant end point event 4

cardiovascular death

Time frame
within 2 years post operation

Secondary outcomes

1

Complex end point event 1

Hospitalization for heart failure

Time frame
within 2 years post operation
2

Complex end point event 2

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

Time frame
within 2 years post operation
3

Complex end point event 3

left ventricular hypertrophy(mm, by Cardiac color ultrasound)

Time frame
within 2 years post operation
4

Complex end point event 4

coronary revascularization(by coronary arteriography)

Time frame
within 2 years post operation

Other outcomes

Sponsors and contacts

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