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Paroxysmal Atrial FibrillationESPFA-CN21NCT05400928

The Effect and Safety of Pulsed Field Ablation (PFA) in Patients With Paroxysmal Atrial Fibrillation (PAF)

A study testing Pulsed Field Ablation in people with Paroxysmal Atrial Fibrillation, run by Tongji Hospital at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This study is aimed to evaluate the Efficacy and Safety of Pulsed Field Ablation (PFA) in Patients with Paroxysmal Atrial Fibrillation (PAF) Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Paroxysmal Atrial Fibrillation
What is being tested?
Pulsed Field Ablation
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
144 participants
Where
1 siteChina
Study dates
5 Jul 2021to 31 Dec 2023
Phase
Interventional
Are there results?
None posted in the registry

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 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Paroxysmal Atrial Fibrillation (PAF)

Who cannot join

  • A history of atrial fibrillation ablation;
  • Left ventricular ejectfraction(LVEF)<35%
  • Left Atrium(LA)（echocardiography）>55mm
  • Thrombus in the left atrial or heart before surgery
  • New York Heart Association(NYHA) grade Ⅲ-Ⅳ
  • second or third degree atrioventricular block
Show all 20Show fewer
  • Significant congenital heart defects (e.g. atrial septal defect or severe pulmonary vein stenosis, but except foramen ovale)
  • Prosthetic valves
  • Pacemakers or defibrillators (ICD)
  • Hypertrophic cardiomyopathy, chronic obstructive pulmonary disease or myxoma
  • Symptomatic carotid stenosis
  • Untreated or uncontrolled hyperthyroidism or hypothyroidism
  • Systemic active infection
  • Renal failure with obvious bleeding tendency or undergoing hemodialysis
  • Myocardial infarction or any cardiac intervention/open surgery within 3 months
  • Stroke or transient ischemic attack within 6 months
  • Obvious contraindication for interventional surgery who were determined by the investigator to be unable to undergo ablation
  • Pregnant or lactating women or those who planned to have a family during the study period
  • Have participated in clinical trials of other drugs or medical devices within 3 months
  • Unsuitable to participate in this clinical trial by the investigator

Trial locations and contacts

1 site in 1 country.

Daowen Wang, PhD contact

86-72-83662842

dwwang@tjh.tjmu.edu.cn

Yan Wang, PhD contact

86-72-83663280

newswangyan@tjh.tjmu.edu.cn

China1 site, 1 recruiting

  • Tongji Hospital

    Wuhan, Hubei, 430030

    Daowen Wang, PhD, 86-27-83662842, dwwang@tjh.tjmu.edu.cn

    Yan Wang, PhD, 86-27-83663280, newswangyan@tjh.tjmu.edu.cn

    Recruiting

Other trials in China

About this study

Official title: The Effect and Safety of Pulsed Field Ablation (PFA) in Patients With Paroxysmal Atrial Fibrillation (PAF)-A Prospective Multicenter Single-arm Study

This study is aimed to evaluate the Efficacy and Safety of Pulsed Field Ablation (PFA) in Patients with Paroxysmal Atrial Fibrillation (PAF)

Read the detailed description

This clinical trial is a prospective, multi-center and single-arm Study. It will be carried out in 3 or more clinical trial institutions, and eligible patients with paroxysmal atrial fibrillation are enrolled. For those patients recruited, pulmonary vein isolation will be performed using pulsed field ablation device (Sichuan Jinjiang Electronic Technology Co., Ltd. Chengdu, China). The safety and efficacy of pulsed field ablation(PFA) in Patients with Paroxysmal Atrial Fibrillation (PAF) will be studied using ring-shaped pulsed field ablation catheter

Being tested
Pulsed Field Ablation
Keywords
Pulsed Field Ablation, Paroxysmal, Ablation, Atrial fibrillation, ring-shaped ablation catheter
Medical subject headings
Atrial Fibrillation

What participants receive

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

  • Pulsed Field AblationDevice

    pulmonary vein isolation will be performed with ring-shaped pulsed field ablation catheter directed by integrated three-dimensional mapping system

Study groups in NCT05400928
Study groupRoleWhat they receive
Three-dimensional Directed Pulsed Field AblationExperimentalParoxysmal atrial fibrillation will be ablated with ring-shaped pulsed field ablation catheter directed by integrated three-dimensional mapping system
Receives: Device: Pulsed Field Ablation

What is being measured

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

  1. Immediate success rate

    Procedural success for PAF is defined as the achievement of complete pulmonary venous electrical isolation

    Measured: during procedure

Secondary outcomes (4)

  1. Procedural success rate at 12 months after procedure

    Procedural success for PAF was defined as the absence of atrial fibrillation/atrial flutter/atrial tachycardia (duration ≥30s) without antiarrhythmic drugs between 3 months and 12 months after ablation

    Measured: between 3 months and 12 months after ablation

  2. The occurrence of hospitalizations or emergency department visit due to symptoms of atrial arrhythmia at 6-month and 12-month follow-up

    The occurrence of hospitalizations or emergency department visit due to symptoms of atrial arrhythmia at 6-month and 12-month of follow-up

    Measured: at 6-month and 12-month

  3. Evaluation of pulsed electric field ablation instrument

    operational stability; Hardware Connection validity; Software operability; degree of satisfaction

    Measured: baseline

  4. Evaluation of a disposable cardiac pulsed electric field ablation catheter

    Whether the catheter can reach its desired location smoothly; X ray and shadow;development is clear; Whether the conduit bend is adjustable; Whether the electrophysiological signal is clear and stable; When used together with the mapping system, whether mapping and 3D modeling can be carried out; When used in conjunction with the mapping system, can the catheter be located; Is it possible to stimulate normally; Whether the ablation can be performed normally; Were there any blood clots after withdrawal; Is the tube body intact after withdrawal from the body; Surgeon satisfaction

    Measured: baseline

Timeline

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

  1. First posted2 Jun 2022
  2. Study start5 Jul 2021
  3. Primary completion31 Dec 2022 (estimated)
  4. Study completion31 Dec 2023 (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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
144 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05400928
Sponsor's protocol ID
JJETCT2021002
Acronym
ESPFA-CN21
Status last verified
May 2022
First submitted
1 Dec 2021
Last updated
2 Jun 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Mansour M, Heist EK, Agarwal R, Bunch TJ, Karst E, Ruskin JN, Mahapatra S. Stroke and Cardiovascular Events After Ablation or Antiarrhythmic Drugs for Treatment of Patients With Atrial Fibrillation. Am J Cardiol. 2018 May 15;121(10):1192-1199. doi: 10.1016/j.amjcard.2018.01.043. Epub 2018 Feb 12.

    PubMed 29571722

  • Hakalahti A, Biancari F, Nielsen JC, Raatikainen MJ. Radiofrequency ablation vs. antiarrhythmic drug therapy as first line treatment of symptomatic atrial fibrillation: systematic review and meta-analysis. Europace. 2015 Mar;17(3):370-8. doi: 10.1093/europace/euu376. Epub 2015 Feb 1.

    PubMed 25643988

  • Reddy VY, Koruth J, Jais P, Petru J, Timko F, Skalsky I, Hebeler R, Labrousse L, Barandon L, Kralovec S, Funosako M, Mannuva BB, Sediva L, Neuzil P. Ablation of Atrial Fibrillation With Pulsed Electric Fields: An Ultra-Rapid, Tissue-Selective Modality for Cardiac Ablation. JACC Clin Electrophysiol. 2018 Aug;4(8):987-995. doi: 10.1016/j.jacep.2018.04.005. Epub 2018 May 11.

    PubMed 30139499

  • Koruth JS, Kuroki K, Iwasawa J, Viswanathan R, Brose R, Buck ED, Donskoy E, Dukkipati SR, Reddy VY. Endocardial ventricular pulsed field ablation: a proof-of-concept preclinical evaluation. Europace. 2020 Mar 1;22(3):434-439. doi: 10.1093/europace/euz341.

    PubMed 31876913

  • Reddy VY, Neuzil P, Koruth JS, Petru J, Funosako M, Cochet H, Sediva L, Chovanec M, Dukkipati SR, Jais P. Pulsed Field Ablation for Pulmonary Vein Isolation in Atrial Fibrillation. J Am Coll Cardiol. 2019 Jul 23;74(3):315-326. doi: 10.1016/j.jacc.2019.04.021. Epub 2019 May 11.

    PubMed 31085321

  • Reddy VY, Dukkipati SR, Neuzil P, Anic A, Petru J, Funasako M, Cochet H, Minami K, Breskovic T, Sikiric I, Sediva L, Chovanec M, Koruth J, Jais P. Pulsed Field Ablation of Paroxysmal Atrial Fibrillation: 1-Year Outcomes of IMPULSE, PEFCAT, and PEFCAT II. JACC Clin Electrophysiol. 2021 May;7(5):614-627. doi: 10.1016/j.jacep.2021.02.014. Epub 2021 Apr 28.

    PubMed 33933412

  • Maor E, Sugrue A, Witt C, Vaidya VR, DeSimone CV, Asirvatham SJ, Kapa S. Pulsed electric fields for cardiac ablation and beyond: A state-of-the-art review. Heart Rhythm. 2019 Jul;16(7):1112-1120. doi: 10.1016/j.hrthm.2019.01.012. Epub 2019 Jan 11.

    PubMed 30641148

  • Sugrue A, Vaidya V, Witt C, DeSimone CV, Yasin O, Maor E, Killu AM, Kapa S, McLeod CJ, Miklavcic D, Asirvatham SJ. Irreversible electroporation for catheter-based cardiac ablation: a systematic review of the preclinical experience. J Interv Card Electrophysiol. 2019 Sep;55(3):251-265. doi: 10.1007/s10840-019-00574-3. Epub 2019 Jul 3.

    PubMed 31270656

  • Jourda F, Providencia R, Marijon E, Bouzeman A, Hireche H, Khoueiry Z, Cardin C, Combes N, Combes S, Boveda S, Albenque JP. Contact-force guided radiofrequency vs. second-generation balloon cryotherapy for pulmonary vein isolation in patients with paroxysmal atrial fibrillation-a prospective evaluation. Europace. 2015 Feb;17(2):225-31. doi: 10.1093/europace/euu215. Epub 2014 Sep 3.

    PubMed 25186456

  • Iwasawa J, Koruth JS, Petru J, Dujka L, Kralovec S, Mzourkova K, Dukkipati SR, Neuzil P, Reddy VY. Temperature-Controlled Radiofrequency Ablation for Pulmonary Vein Isolation in Patients With Atrial Fibrillation. J Am Coll Cardiol. 2017 Aug 1;70(5):542-553. doi: 10.1016/j.jacc.2017.06.008.

    PubMed 28750697

  • Buist TJ, Adiyaman A, Smit JJJ, Ramdat Misier AR, Elvan A. Arrhythmia-free survival and pulmonary vein reconnection patterns after second-generation cryoballoon and contact-force radiofrequency pulmonary vein isolation. Clin Res Cardiol. 2018 Jun;107(6):498-506. doi: 10.1007/s00392-018-1211-9. Epub 2018 Feb 6.

    PubMed 29411114

  • Furnkranz A, Brugada J, Albenque JP, Tondo C, Bestehorn K, Wegscheider K, Ouyang F, Kuck KH. Rationale and Design of FIRE AND ICE: A multicenter randomized trial comparing efficacy and safety of pulmonary vein isolation using a cryoballoon versus radiofrequency ablation with 3D-reconstruction. J Cardiovasc Electrophysiol. 2014 Dec;25(12):1314-20. doi: 10.1111/jce.12529. Epub 2014 Nov 12.

    PubMed 25146732

  • Hindricks G, Potpara T, Dagres N, Arbelo E, Bax JJ, Blomstrom-Lundqvist C, Boriani G, Castella M, Dan GA, Dilaveris PE, Fauchier L, Filippatos G, Kalman JM, La Meir M, Lane DA, Lebeau JP, Lettino M, Lip GYH, Pinto FJ, Thomas GN, Valgimigli M, Van Gelder IC, Van Putte BP, Watkins CL; ESC Scientific Document Group. 2020 ESC Guidelines for the diagnosis and management of atrial fibrillation developed in collaboration with the European Association for Cardio-Thoracic Surgery (EACTS): The Task Force for the diagnosis and management of atrial fibrillation of the European Society of Cardiology (ESC) Developed with the special contribution of the European Heart Rhythm Association (EHRA) of the ESC. Eur Heart J. 2021 Feb 1;42(5):373-498. doi: 10.1093/eurheartj/ehaa612. No abstract available.

    PubMed 32860505

  • Wang Y, Lai HL, Chen Q, Liu H, Liu QM, Huang WB, Tao Y, Xiong Q, Zhou N, Zhao C, Qiu J, Xu Z, Wang DW. Application of a circular-shaped pulsed field ablation catheter with magnetic sensors for pulmonary vein isolation: a multi-centre clinical study report. Europace. 2024 Mar 30;26(4):euae068. doi: 10.1093/europace/euae068.

    PubMed 38584395

Questions about this trial

What is this clinical trial studying?

A study testing Pulsed Field Ablation in people with Paroxysmal Atrial Fibrillation, run by Tongji 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 1 inclusion and 20 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: status not confirmed, as of the sponsor's last update on 2 Jun 2022. 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. 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?

Results are not available in the source record.

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

Contact Daowen Wang, PhD (86-72-83662842, dwwang@tjh.tjmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Immediate success rate (time frame: during 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 NCT05400928, which also lists 14 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 2 Jun 2022.

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