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Persistent Atrial FibrillationOFF-MEDNCT07320768

Renal Denervation Combined With Pulsed Field Ablation to Prevent Recurrence in Persistent Atrial Fibrillation

A study testing renal denervation and Pulsed-Field Ablation (PFA) in people with Persistent Atrial Fibrillation, run by Shanghai Chest Hospital at 1 site in China.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

The goal of this clinical trial is to learn whether adding renal denervation (RDN) to pulsed-field ablation (PFA) reduces recurrence of atrial tachyarrhythmias in adults (≥18 years) with persistent atrial fibrillation undergoing first-time ablation while off antiarrhythmic drugs. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Persistent Atrial Fibrillation
What is being tested?
renal denervation and Pulsed-Field Ablation (PFA)
Type of treatment
Surgery or procedure
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
86 participants
Where
1 siteChina
Study dates
1 Jan 2026to 1 Jun 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age > 18 years.
  • Patients with persistent atrial fibrillation undergoing first-time catheter ablation (defined as any episode lasting ≥7 days).
  • Symptomatic atrial fibrillation refractory to or intolerant of at least one class I or III antiarrhythmic drug and scheduled for guideline-directed catheter ablation.
  • Able to understand the study purpose, voluntarily participate, and sign the written informed consent form.

Who cannot join

  • Presence of advanced structural heart disease.
  • Life expectancy < 12 months.
  • Blood pressure < 90/60 mmHg.
  • Pregnant or lactating women.
  • Anatomical abnormalities of the renal arteries unsuitable for treatment as determined by pre-procedural renal CTA.
  • History of renal artery intervention, impaired renal function with estimated glomerular filtration rate (eGFR) < 45 mL/min/1.73 m² (calculated by the MDRD equation).
Show all 11Show fewer
  • Secondary atrial fibrillation due to electrolyte imbalance, thyroid disorders, or other reversible or non-cardiac causes.
  • Contraindication to pulsed-field ablation (e.g., left atrial thrombus, prior atrial septal defect occluder implantation, or permanent metallic implant in the left atrium) or to anticoagulation therapy.
  • Known inability to obtain vascular access or contraindication to femoral venous puncture.
  • Heart failure with left ventricular ejection fraction < 30% documented by transthoracic echocardiography within 3 months before ablation.
  • Patients with current or anticipated need for pacemaker, implantable cardioverter-defibrillator (ICD), or cardiac resynchronization therapy (CRT), or prior transseptal closure with occluder device for atrial septal defect or patent foramen ovale.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Shanghai Chest Hospital

    Shanghai, 200030

Other trials in China

About this study

Official title: The Efficacy and Safety of Renal Denervation Combined With Pulsed Field Ablation in Preventing Recurrence of Atrial Arrhythmia in Patients With Persistent Atrial Fibrillation: An OFF-MED Trial

The goal of this clinical trial is to learn whether adding renal denervation (RDN) to pulsed-field ablation (PFA) reduces recurrence of atrial tachyarrhythmias in adults (≥18 years) with persistent atrial fibrillation undergoing first-time ablation while off antiarrhythmic drugs.

The main questions it aims to answer are:

  1. Does PFA+RDN, compared with PFA alone, reduce the proportion of participants with any AF/atrial flutter/atrial tachycardia ≥30 seconds at 12 month?
  2. Is PFA+RDN safe, as measured by procedure-related serious adverse events through 30 days?
Being tested
renal denervation, Pulsed-Field Ablation (PFA)
Keywords
Persistent Atrial Fibrillation, renal denervation (RDN), pulsed-field ablation (PFA)
Medical subject headings
Atrial Fibrillation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • renal denervationProcedure or surgery

    Renal denervation is a catheter-based procedure performed after renal angiography confirms no significant stenosis. A specialized catheter delivers low-energy pulses inside both renal arteries to disrupt overactive sympathetic nerves surrounding the vessels. Energy is applied in a spiral pattern from distal to proximal segments. The procedure is performed during the same session as PFA under anticoagulation.

  • Pulsed-Field Ablation (PFA)Procedure or surgery

    Catheter-based PFA of the left atrium for wide-antral pulmonary vein isolation using a multielectrode PFA system. Entrance/exit block must be confirmed.

Study groups in NCT07320768
Study groupRoleWhat they receive
pulsed-field ablation aloneSham comparatorNot described
Receives: Procedure: Pulsed-Field Ablation (PFA)
renal denervation combined with pulsed-field ablationExperimentalNot described
Receives: Procedure: renal denervation; Procedure: Pulsed-Field Ablation (PFA)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Freedom from Atrial Arrhythmia Recurrence

    Absence of any documented atrial tachyarrhythmia - including atrial fibrillation (AF), atrial tachycardia (AT), or atrial flutter (AFL) lasting ≥30 seconds - occurring

    Measured: within 12 Months After the Index Procedure

Secondary outcomes (6)

  1. Freedom from atrial tachyarrhythmia recurrence

    Absence of any documented atrial tachyarrhythmia - including atrial fibrillation (AF), atrial tachycardia (AT), or atrial flutter (AFL) lasting ≥30 seconds - occurring

    Measured: within 3 months after the index procedure

  2. Atrial fibrillation burden

    AF burden measured by 24-hour (or longer) Holter monitoring at 3、6、9、12 months, calculated as the proportion of AF duration to total recording time, in participants not receiving antiarrhythmic drugs.

    Measured: at 3、6、9、12 months

  3. Change in blood pressure

    Change in systolic and diastolic blood pressure from baseline to post-procedure, 1, 3, 6, 12-month follow-up visits.

    Measured: immediately, at 1 month, and at 3 months after procedure

  4. Major adverse cardiovascular events (MACE)

    Incidence of death, stroke, heart failure, major bleeding, non-stroke thromboembolic events, and cardiovascular hospitalization, reported both as individual and composite outcomes.

    Measured: up to 12 months after ablation

  5. Changes in serum creatinine levels during follow-up.

    Changes in renal function during follow-up. Using serum creatinine levels for assessment.

    Measured: During 12 months

  6. Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]), reported both as individual and composite outcomes.

    1. Cardiac complications: pericardial effusion, cardiac tamponade, pericarditis, myocardial injury, coronary artery spasm or injury, and clinically significant bradyarrhythmia.
    2. Vascular complications: access-site bleeding, hematoma, pseudoaneurysm, arteriovenous fistula, arterial dissection, and vascular occlusion.
    3. Renal complications: renal artery stenosis, renal artery dissection, renal artery perforation or rupture, renal infarction, and clinically significant decline in renal function.
    4. Neurological events: stroke and transient ischemic attack.
    5. Thromboembolic events.
    6. Major bleeding.
    7. Symptomatic hypotension.
    8. Death.
    9. Other serious adverse events judged related or possibly related to the study procedure.

    Measured: 1 month after procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Jan 2026
  2. Study start1 Jan 2026
  3. Primary completion1 Jan 2027 (estimated)
  4. Study completion1 Jun 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
86 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07320768
Sponsor's protocol ID
IS25217
Acronym
OFF-MED
Status last verified
Dec 2025
First submitted
21 Dec 2025
Last updated
29 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Heradien M, Mahfoud F, Greyling C, Lauder L, van der Bijl P, Hettrick DA, Stilwaney W, Sibeko S, Jansen van Rensburg R, Peterson D, Khwinani B, Goosen A, Saaiman JA, Ukena C, Bohm M, Brink PA. Renal denervation prevents subclinical atrial fibrillation in patients with hypertensive heart disease: Randomized, sham-controlled trial. Heart Rhythm. 2022 Nov;19(11):1765-1773. doi: 10.1016/j.hrthm.2022.06.031. Epub 2022 Jun 30.

    PubMed 35781044

  • Steinberg JS, Shabanov V, Ponomarev D, Losik D, Ivanickiy E, Kropotkin E, Polyakov K, Ptaszynski P, Keweloh B, Yao CJ, Pokushalov EA, Romanov AB. Effect of Renal Denervation and Catheter Ablation vs Catheter Ablation Alone on Atrial Fibrillation Recurrence Among Patients With Paroxysmal Atrial Fibrillation and Hypertension: The ERADICATE-AF Randomized Clinical Trial. JAMA. 2020 Jan 21;323(3):248-255. doi: 10.1001/jama.2019.21187.

    PubMed 31961420

  • Turagam MK, Whang W, Miller MA, Neuzil P, Aryana A, Romanov A, Cuoco FA, Mansour M, Lakkireddy D, Michaud GF, Dukkipati SR, Cammack S, Reddy VY. Renal Sympathetic Denervation as Upstream Therapy During Atrial Fibrillation Ablation: Pilot HFIB Studies and Meta-Analysis. JACC Clin Electrophysiol. 2021 Jan;7(1):109-123. doi: 10.1016/j.jacep.2020.08.013. Epub 2020 Oct 28.

    PubMed 33478702

  • Romanov A, Pokushalov E, Ponomarev D, Strelnikov A, Shabanov V, Losik D, Karaskov A, Steinberg JS. Pulmonary vein isolation with concomitant renal artery denervation is associated with reduction in both arterial blood pressure and atrial fibrillation burden: Data from implantable cardiac monitor. Cardiovasc Ther. 2017 Aug;35(4). doi: 10.1111/1755-5922.12264.

    PubMed 28423234

  • Pokushalov E, Romanov A, Corbucci G, Artyomenko S, Baranova V, Turov A, Shirokova N, Karaskov A, Mittal S, Steinberg JS. A randomized comparison of pulmonary vein isolation with versus without concomitant renal artery denervation in patients with refractory symptomatic atrial fibrillation and resistant hypertension. J Am Coll Cardiol. 2012 Sep 25;60(13):1163-70. doi: 10.1016/j.jacc.2012.05.036. Epub 2012 Sep 5.

    PubMed 22958958

  • Hering D, Lambert EA, Marusic P, Walton AS, Krum H, Lambert GW, Esler MD, Schlaich MP. Substantial reduction in single sympathetic nerve firing after renal denervation in patients with resistant hypertension. Hypertension. 2013 Feb;61(2):457-64. doi: 10.1161/HYPERTENSIONAHA.111.00194. Epub 2012 Nov 19.

    PubMed 23172929

  • Duytschaever M, Demolder A, Phlips T, Sarkozy A, El Haddad M, Taghji P, Knecht S, Tavernier R, Vandekerckhove Y, De Potter T. PulmOnary vein isolation With vs. without continued antiarrhythmic Drug trEatment in subjects with Recurrent Atrial Fibrillation (POWDER AF): results from a multicentre randomized trial. Eur Heart J. 2018 Apr 21;39(16):1429-1437. doi: 10.1093/eurheartj/ehx666.

    PubMed 29211857

  • Kirchhof P, Camm AJ, Goette A, Brandes A, Eckardt L, Elvan A, Fetsch T, van Gelder IC, Haase D, Haegeli LM, Hamann F, Heidbuchel H, Hindricks G, Kautzner J, Kuck KH, Mont L, Ng GA, Rekosz J, Schoen N, Schotten U, Suling A, Taggeselle J, Themistoclakis S, Vettorazzi E, Vardas P, Wegscheider K, Willems S, Crijns HJGM, Breithardt G; EAST-AFNET 4 Trial Investigators. Early Rhythm-Control Therapy in Patients with Atrial Fibrillation. N Engl J Med. 2020 Oct 1;383(14):1305-1316. doi: 10.1056/NEJMoa2019422. Epub 2020 Aug 29.

    PubMed 32865375

  • Piccini JP, Caso V, Connolly SJ, Fox KAA, Oldgren J, Jones WS, Gorog DA, Durdil V, Viethen T, Neumann C, Mundl H, Patel MR; PACIFIC-AF Investigators. Safety of the oral factor XIa inhibitor asundexian compared with apixaban in patients with atrial fibrillation (PACIFIC-AF): a multicentre, randomised, double-blind, double-dummy, dose-finding phase 2 study. Lancet. 2022 Apr 9;399(10333):1383-1390. doi: 10.1016/S0140-6736(22)00456-1. Epub 2022 Apr 3.

    PubMed 35385695

  • Lin HJ, Wolf PA, Kelly-Hayes M, Beiser AS, Kase CS, Benjamin EJ, D'Agostino RB. Stroke severity in atrial fibrillation. The Framingham Study. Stroke. 1996 Oct;27(10):1760-4. doi: 10.1161/01.str.27.10.1760.

    PubMed 8841325

  • Noubiap JJ, Feteh VF, Middeldorp ME, Fitzgerald JL, Thomas G, Kleinig T, Lau DH, Sanders P. A meta-analysis of clinical risk factors for stroke in anticoagulant-naive patients with atrial fibrillation. Europace. 2021 Oct 9;23(10):1528-1538. doi: 10.1093/europace/euab087.

    PubMed 34279604

  • Benjamin EJ, Wolf PA, D'Agostino RB, Silbershatz H, Kannel WB, Levy D. Impact of atrial fibrillation on the risk of death: the Framingham Heart Study. Circulation. 1998 Sep 8;98(10):946-52. doi: 10.1161/01.cir.98.10.946.

    PubMed 9737513

  • Du X, Guo L, Xia S, Du J, Anderson C, Arima H, Huffman M, Yuan Y, Zheng Y, Wu S, Guang X, Zhou X, Lin H, Cheng X, Dong J, Ma C. Atrial fibrillation prevalence, awareness and management in a nationwide survey of adults in China. Heart. 2021 Jan 28;107(7):535-41. doi: 10.1136/heartjnl-2020-317915. Online ahead of print.

    PubMed 33509976

  • Kalman JM, Sanders P, Rosso R, Calkins H. Should We Perform Catheter Ablation for Asymptomatic Atrial Fibrillation? Circulation. 2017 Aug 1;136(5):490-499. doi: 10.1161/CIRCULATIONAHA.116.024926.

    PubMed 28760871

  • Calkins H, Hindricks G, Cappato R, Kim YH, Saad EB, Aguinaga L, Akar JG, Badhwar V, Brugada J, Camm J, Chen PS, Chen SA, Chung MK, Nielsen JC, Curtis AB, Davies DW, Day JD, d'Avila A, de Groot NMSN, Di Biase L, Duytschaever M, Edgerton JR, Ellenbogen KA, Ellinor PT, Ernst S, Fenelon G, Gerstenfeld EP, Haines DE, Haissaguerre M, Helm RH, Hylek E, Jackman WM, Jalife J, Kalman JM, Kautzner J, Kottkamp H, Kuck KH, Kumagai K, Lee R, Lewalter T, Lindsay BD, Macle L, Mansour M, Marchlinski FE, Michaud GF, Nakagawa H, Natale A, Nattel S, Okumura K, Packer D, Pokushalov E, Reynolds MR, Sanders P, Scanavacca M, Schilling R, Tondo C, Tsao HM, Verma A, Wilber DJ, Yamane T. 2017 HRS/EHRA/ECAS/APHRS/SOLAECE expert consensus statement on catheter and surgical ablation of atrial fibrillation. Heart Rhythm. 2017 Oct;14(10):e275-e444. doi: 10.1016/j.hrthm.2017.05.012. Epub 2017 May 12. No abstract available.

    PubMed 28506916

Questions about this trial

What is this clinical trial studying?

A study testing renal denervation and Pulsed-Field Ablation (PFA) in people with Persistent Atrial Fibrillation, run by Shanghai Chest Hospital at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 29 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Freedom from Atrial Arrhythmia Recurrence (time frame: within 12 Months After the Index Procedure). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07320768, which also lists 16 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2026.

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