Clinical trial Recruiting at 1 site Interventional Ages 18 to 75

Combining Pulmonary Vein Isolation with Renal Denervation for Atrial Fibrillation and Hypertension

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)

Run by The First Affiliated Hospital of Xiamen University · NCT05841615 · Data updated 2026-11-12

This study is testing if combining two treatments, Pulmonary Vein Isolation and Renal Denervation, can help people with Atrial Fibrillation and high blood pressure feel better and have better results than using just one treatment alone.

More Atrial Fibrillation (AF) trials

Quick facts

Study typeInterventional
Ages18 Years to 75 Years
SexAll
Enrollment120 (estimated)
SponsorThe First Affiliated Hospital of Xiamen University
Academic / other
Locations1 site (Xiamen, Fujian)
StatusRecruiting
StartedSeptember 1, 2023
Main results expectedApril 30, 2026
Study endsApril 30, 2028
Registry record updatedMarch 13, 2024
Trial IDNCT05841615 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are adults aged 18 to 75 with diagnosed Atrial Fibrillation and hypertension that meets specific blood pressure criteria.

Probably not a fit

Patients with certain renal conditions, previous renal interventions, or secondary hypertension may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study investigates the effects and safety of combining Pulmonary Vein Isolation (PVI) with Renal Denervation (RDN) in patients suffering from Atrial Fibrillation (AF) and Hypertension (HTN). Given the high failure rate of PVI alone, the research aims to determine if the addition of RDN can improve outcomes for these patients. Participants will be monitored for their blood pressure and ECG results to assess the effectiveness of the combined treatment approach. The study is designed to provide insights into a potentially new treatment paradigm for managing AF in the context of hypertension.

Why it matters

Potential benefit: If successful, this approach could lead to improved treatment outcomes for patients with Atrial Fibrillation and Hypertension.

How similar studies have gone: While the combination of PVI and RDN is a novel approach, previous studies have shown promise in treating AF with various interventions, indicating potential for success.

Who can join: the full rules

Show full inclusion / exclusion 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

Where it's running

  • the first affiliated hopital of Xiamen University
    Xiamen, Fujian, China
    Recruiting

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

  • Two Pulse Field Ablation Systems for Atrial Fibrillation

    This trial tests whether two different pulse field ablation systems perform similarly in persistent symptomatic AF patients, with a heart monitor implanted to track rhythm for up to 36 months.

    Recruiting Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute) · Pittsburgh, Pennsylvania · NCT07883629

  • Abbreviated antithrombotic therapy after PCI in AF and MI

    This trial tests whether DOAC-only therapy works as well as DOAC plus clopidogrel after PCI in people with atrial fibrillation and a recent heart attack.

    Recruiting Chonnam National University Hospital · Gwangju, Gwangju · NCT07583784

  • Catheter ablation for AF after spontaneous intracranial hemorrhage: SAFER-AF

    This study tests whether catheter ablation can offer better long-term outcomes than usual care for adults with atrial fibrillation who recently had a spontaneous intracranial hemorrhage.

    Recruiting at 2 sites Beijing Anzhen Hospital · Hefei, Anhui and 6 other locations · NCT07316270

  • Pulsed Field vs Cryoballoon for Pulmonary Vein Isolation in Atrial Fibrillation

    This trial tests whether pulsed field ablation can shorten the procedure for first-time PVI in AF patients compared with cryoballoon ablation, while keeping safety and effectiveness similar.

    Recruiting St. Josefs-Hospital Wiesbaden GmbH · Wiesbaden · NCT07910370

  • Pulsed Field Ablation vs Cryoablation for Atrial Fibrillation Under Deep Sedation

    This trial tests whether pulsed field ablation (PFA) done under deep sedation works as well as cryoballoon ablation for treating atrial fibrillation, aiming to avoid general anesthesia.

    Recruiting East Sussex Healthcare NHS Trust · Eastbourne · NCT07900685

  • Bachmann’s Bundle Pacing vs Right Atrial Appendage Pacing for AF

    This study tests two common atrial pacing methods to see which one is safer over 12 months for people getting a new pacemaker, ICD, or CRT device.

    Recruiting Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute) · Pittsburgh, Pennsylvania · NCT07874763

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.