Quantitative Superior Vena Cava Isolation in Addition to Pulmonary Vein Isolation for Paroxysmal Atrial Fibrillation

NCT05908955 | Recruiting

• 1 other identifier: 2023-GSP-GG-33
• Study Type: interventional
• Target: 290
• Locations: 1 country
• Sites: 1

Brief Summary

Pulmonary vein isolation (PVI) for paroxysmal atrial fibrillation (PAF) has limited success. The superior vena cava (SVC) has been identified as one of the most common non-pulmonary vein triggers for PAF. It is estimated that SVC isolation (SVCI) could improve the clinical results for patients with PAF. However, results from previous studies about SVCI remain controversial. It is possible that safety concerns for SVCI outweigh its benefits and lead to inadequate ablation. To address this issue, the introduction of a quantitative ablation index (AI) for SVCI may provide a solution. The goal of this prospective, randomized controlled trial is to test the efficacy and safety of quantitative SVCI in addition to PVI in PAF. Participants with PAF will be randomly assigned to either PVI group or PVI+ quantitative SVCI group in a 1:1 ratio and will be followed up for 12 months. The main questions it aims to answer are:

1. 1.Evaluate the efficacy of PVI+SVCI guided by quantitative AI.
2. 2.Assess the safety of PVI+SVCI guided by quantitative AI.

Conditions

Atrial Fibrillation

Keywords

Radiofrequency ablation; Pulmonary vein; superior vena cava; clinical trial

Outcome Measures

Primary Outcomes (1)

• Proportion of patients with maintenance of sinus rhythm measured by 14-day Holter ECG at 3 months follow-up

  The proportion of patients that are freedom from AF, atrial flutter, or atrial tachycardia for longer than 30 seconds measured by 14-day Holter ECG at 3 months after the index ablation.

  3 months

Secondary Outcomes (2)

• Proportion of patients with maintenance of sinus rhythm measured by 14-day Holter ECG at 12 months follow-up

  12 months

• Incidence of treatment emergent adverse events post ablation

  12 months

Study Arms (2)

PVI

ACTIVE COMPARATOR

Participants in this group will receive pulmonary vein isolation.

Procedure: PVI

PVI+SVCI

EXPERIMENTAL

Participants in this group will receive superior vena cava isolation in addition to pulmonary vein isolation.

Procedure: PVI+ quantitative SVCI

Interventions

PVI PROCEDURE

pulmonary vein isolation

PVI

PVI+ quantitative SVCI PROCEDURE

pulmonary vein isolation and superior vena cava isolation guided by quantitative ablation index

PVI+SVCI

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Symptomatic paroxysmal AF that are unresponsive to antiarrhythmic drugs (one or more than one).
• Willing to undergo catheter ablation for AF.
• Age: 40-75 years old.

You may not qualify if:

• History of any type of catheter ablation for cardiac arrhythmias.
• History of any type of thoracic surgery, including cardiac surgery.
• History of malignant tumors.
• History of permanent pacemaker implantation.
• Peripherally inserted central catheter for long-term
• Heart failure (left ventricular ejection fraction ≤40% or NYHA class III\~IV).
• Sinus node dysfunction
• Allergy to contrast agents.
• Pregnancy or lactation.
• Age: \<40yrs or \>75yrs.

Sponsors & Collaborators

• Chinese Academy of Medical Sciences, Fuwai Hospital: lead

Study Sites (1)

Chinese Academy of Medical Science, Fuwai hospital

Beijing, Beijing Municipality, 100051, China

RECRUITING

Related Publications (13)

• Zhou Z, Hu D. An epidemiological study on the prevalence of atrial fibrillation in the Chinese population of mainland China. J Epidemiol. 2008;18(5):209-16. doi: 10.2188/jea.je2008021. Epub 2008 Sep 8.

  PMID: 18776706 BACKGROUND

• Mark DB, Anstrom KJ, Sheng S, Piccini JP, Baloch KN, Monahan KH, Daniels MR, Bahnson TD, Poole JE, Rosenberg Y, Lee KL, Packer DL; CABANA Investigators. Effect of Catheter Ablation vs Medical Therapy on Quality of Life Among Patients With Atrial Fibrillation: The CABANA Randomized Clinical Trial. JAMA. 2019 Apr 2;321(13):1275-1285. doi: 10.1001/jama.2019.0692.

  PMID: 30874716 BACKGROUND

• Corrado A, Bonso A, Madalosso M, Rossillo A, Themistoclakis S, Di Biase L, Natale A, Raviele A. Impact of systematic isolation of superior vena cava in addition to pulmonary vein antrum isolation on the outcome of paroxysmal, persistent, and permanent atrial fibrillation ablation: results from a randomized study. J Cardiovasc Electrophysiol. 2010 Jan;21(1):1-5. doi: 10.1111/j.1540-8167.2009.01577.x. Epub 2009 Sep 1.

  PMID: 19732237 BACKGROUND

• Miyazaki S, Takigawa M, Kusa S, Kuwahara T, Taniguchi H, Okubo K, Nakamura H, Hachiya H, Hirao K, Takahashi A, Iesaka Y. Role of arrhythmogenic superior vena cava on atrial fibrillation. J Cardiovasc Electrophysiol. 2014 Apr;25(4):380-386. doi: 10.1111/jce.12342. Epub 2014 Jan 6.

  PMID: 24320606 BACKGROUND

• Santangeli P, Zado ES, Hutchinson MD, Riley MP, Lin D, Frankel DS, Supple GE, Garcia FC, Dixit S, Callans DJ, Marchlinski FE. Prevalence and distribution of focal triggers in persistent and long-standing persistent atrial fibrillation. Heart Rhythm. 2016 Feb;13(2):374-82. doi: 10.1016/j.hrthm.2015.10.023. Epub 2015 Oct 23.

  PMID: 26477712 BACKGROUND

• Da Costa A, Levallois M, Romeyer-Bouchard C, Bisch L, Gate-Martinet A, Isaaz K. Remote-controlled magnetic pulmonary vein isolation combined with superior vena cava isolation for paroxysmal atrial fibrillation: a prospective randomized study. Arch Cardiovasc Dis. 2015 Mar;108(3):163-71. doi: 10.1016/j.acvd.2014.10.005. Epub 2015 Feb 7.

  PMID: 25662699 BACKGROUND

• Ejima K, Kato K, Iwanami Y, Henmi R, Yagishita D, Manaka T, Fukushima K, Arai K, Ashihara K, Shoda M, Hagiwara N. Impact of an Empiric Isolation of the Superior Vena Cava in Addition to Circumferential Pulmonary Vein Isolation on the Outcome of Paroxysmal Atrial Fibrillation Ablation. Am J Cardiol. 2015 Dec 1;116(11):1711-6. doi: 10.1016/j.amjcard.2015.09.005. Epub 2015 Sep 10.

  PMID: 26434513 BACKGROUND

• Sharma SP, Sangha RS, Dahal K, Krishnamoorthy P. The role of empiric superior vena cava isolation in atrial fibrillation: a systematic review and meta-analysis of randomized controlled trials. J Interv Card Electrophysiol. 2017 Jan;48(1):61-67. doi: 10.1007/s10840-016-0198-2. Epub 2016 Oct 14.

  PMID: 27743289 BACKGROUND

• Higuchi K, Yamauchi Y, Hirao K, Marrouche NF. The importance of superior vena cava isolation in ablation strategy for atrial fibrillation. Curr Opin Cardiol. 2013 Jan;28(1):2-6. doi: 10.1097/HCO.0b013e32835b099b.

  PMID: 23128496 BACKGROUND

• Zhang T, Wang Y, Liang Z, Zhao H, Han Z, Wang Y, Wu Y, Ren X. Effect of Combined Pulmonary Vein and Superior Vena Cava Isolation on the Outcome of Second Catheter Ablation for Paroxysmal Atrial Fibrillation. Am J Cardiol. 2020 Jun 15;125(12):1845-1850. doi: 10.1016/j.amjcard.2020.03.030. Epub 2020 Apr 3.

  PMID: 32305224 BACKGROUND

• Yamashita S, Tokuda M, Isogai R, Tokutake K, Yokoyama K, Narui R, Kato M, Tanigawa S, Inada K, Matsuo S, Miyanaga S, Sugimoto K, Yoshimura M, Yamane T. Spiral activation of the superior vena cava: The utility of ultra-high-resolution mapping for caval isolation. Heart Rhythm. 2018 Feb;15(2):193-200. doi: 10.1016/j.hrthm.2017.09.035. Epub 2017 Sep 22.

  PMID: 28943481 BACKGROUND

• Miyazaki S, Taniguchi H, Kusa S, Uchiyama T, Hirao K, Iesaka Y. Conduction recovery after electrical isolation of superior vena cava--prevalence and electrophysiological properties. Circ J. 2013;77(2):352-8. doi: 10.1253/circj.cj-12-0951. Epub 2012 Oct 23.

  PMID: 23090663 BACKGROUND

• Guan W, Li X, Chen K, Yao Y, Liu J. Anatomical variation of femoral vessels and ultrasound-guided femoral vein puncture for catheter ablation of arrhythmias. Pacing Clin Electrophysiol. 2024 Feb;47(2):330-335. doi: 10.1111/pace.14924. Epub 2024 Jan 19.

  PMID: 38240379 DERIVED

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Jun Liu, MD, PhD

  Chinese Academy of Medical Sciences, Fuwai Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Wenchi Guan, MD, PhD

CONTACT

+8613521270747; wenchi.guan@outlook.com

Jun Liu, MD, PhD

CONTACT

+8615810319596; liujundoctor@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 8, 2023
• First Posted: June 18, 2023
• Study Start: March 17, 2024
• Primary Completion: September 30, 2025
• Study Completion: December 31, 2025
• Last Updated: February 14, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)