Atrial FibrillationSCORENCT05908955
Quantitative Superior Vena Cava Isolation in Addition to Pulmonary Vein Isolation for Paroxysmal Atrial Fibrillation
A study testing PVI and PVI+ quantitative SVCI in people with Atrial Fibrillation, run by Chinese Academy of Medical Sciences, Fuwai Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- PVI and PVI+ quantitative SVCI
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 290 participants
- Where
- 1 siteChina
- Study dates
- 17 Mar 2024to 31 Dec 2025
- 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 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
Show all 10Show fewer
- Sinus node dysfunction
- Allergy to contrast agents.
- Pregnancy or lactation.
- Age: <40yrs or >75yrs.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Chinese Academy of Medical Science, Fuwai hospital
Beijing, Beijing Municipality, 100051
Wenchi Guan, MD, +8613521270747, wenchi.guan@outlook.com
About this study
Official title: Efficacy and Safety of Quantitative Superior Vena Cava Isolation in Addition to Pulmonary Vein Isolation in Patients With Paroxysmal Atrial Fibrillation: the SCORE Randomized Controlled Trial
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:
Read more
- Evaluate the efficacy of PVI+SVCI guided by quantitative AI.
- Assess the safety of PVI+SVCI guided by quantitative AI.
The primary end point is treatment success at 3 months after the index ablation. The secondary end points include treatment success at 12 months, and safety outcomes.
Read the detailed description
Catheter ablation has emerged as an effective treatment for drug-refractory PAF and is recommended as first-line therapy by current guidelines. PVI is considered the cornerstone of catheter ablation for atrial fibrillation (AF). However, despite persistent PVI, a subgroup of patients may experience recurrent AF due to focal ectopic discharges originating outside the pulmonary veins. Among the non-pulmonary vein triggers, the SVC stands out as a common culprit, making it a promising ablation target for maintaining sinus rhythm.
Nevertheless, results from previous studies that evaluate the efficacy of SVCI showed conflicting results. One possible explanation is that SVC is adjacent to critical anatomy structures (such as the sinus node and the phrenic nerve), which raises safety concerns and often leads to inadequate ablation.
Therefore, it is necessary to establish standardized ablation procedure for SVCI, ensuring both safety and efficacy. To address this issue, we proposed the concept of "quantitative ablation for SVCI." By introducing AI as a quantitative measure, it is possible to achieve precise catheter ablation while minimizing the risk of procedure-related complications.
The SCORE trial is single-center, prospective, randomized controlled trial aiming to enroll 290 patients with 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 goal is to determine whether quantitative SVCI could improve clinical results for PAF when added to PVI. The key objectives are as follows:
- Evaluate the efficacy of PVI+SVCI guided by quantitative AI.
- Assess the safety of PVI+SVCI guided by quantitative AI.
The primary endpoint of the study is treatment success, defined as freedom from AF, atrial flutter, or atrial tachycardia lasting longer than 30 seconds, at the 3-month follow-up. Secondary endpoints include treatment success at the 12-month follow-up and safety outcomes, including death, stroke/TIA, pericardial tamponade or effusion requiring drainage, pulmonary vein stenosis, superior vena cava stenosis, diaphragmatic nerve injury or paralysis, sinus node dysfunction, and atrial esophageal fistula.
- Conditions
- Atrial Fibrillation
- Being tested
- PVI, PVI+ quantitative SVCI
- Keywords
- Radiofrequency ablation, Pulmonary vein, superior vena cava, clinical trial
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PVIProcedure or surgery
pulmonary vein isolation
PVI+ quantitative SVCIProcedure or surgery
pulmonary vein isolation and superior vena cava isolation guided by quantitative ablation index
| Study group | Role | What they receive |
|---|---|---|
| PVI | Active comparator | Participants in this group will receive pulmonary vein isolation. Receives: Procedure: PVI |
| PVI+SVCI | Experimental | Participants in this group will receive superior vena cava isolation in addition to pulmonary vein isolation. Receives: Procedure: PVI+ quantitative SVCI |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months
Secondary outcomes (2)
Proportion of patients with maintenance of sinus rhythm measured by 14-day Holter ECG at 12 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 12 months after the index ablation.
Measured: 12 months
Incidence of treatment emergent adverse events post ablation
Incidence of treatment emergent adverse events that include death, stroke/TIA, pericardial tamponade or effusion that requires drainage, pulmonary vein stenosis, superior vena cava stenosis, diaphragmatic nerve injury or paralysis, sinus node dysfunction, and atrial esophageal fistula.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2023
- Study start17 Mar 2024
- Primary completion30 Sep 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by Chinese Academy of Medical Sciences, Fuwai HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Outcomes assessor
- Enrolment
- 290 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jun Liu,MD, Chinese Academy of Medical Sciences, Fuwai Hospital
- Investigators
- Jun Liu, MD, PhD, Principal investigator, Chinese Academy of Medical Sciences, Fuwai Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05908955
- Sponsor's protocol ID
- 2023-GSP-GG-33
- Acronym
- SCORE
- Status last verified
- Feb 2025
- First submitted
- 8 Jun 2023
- Last updated
- 14 Feb 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 18776706Mark 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.
PubMed 30874716Corrado 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.
PubMed 19732237Miyazaki 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.
PubMed 24320606Santangeli 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.
PubMed 26477712Da 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.
PubMed 25662699Ejima 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.
PubMed 26434513Sharma 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.
PubMed 27743289Higuchi 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.
PubMed 23128496Zhang 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.
PubMed 32305224Yamashita 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.
PubMed 28943481Miyazaki 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.
PubMed 23090663Guan 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.
PubMed 38240379
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Quantitative Superior Vena Cava Isolation in Addition to Pulmonary Vein Isolation in Patients With Paroxysmal Atrial Fibrillation: the SCORE Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05908955
- Acronym / sponsor ID
- SCORE / 2023-GSP-GG-33
- Conditions
- Atrial Fibrillation
- Keywords
- Radiofrequency ablation, Pulmonary vein, superior vena cava, clinical trial
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 290 participants (estimated)
- Lead sponsor
- Chinese Academy of Medical Sciences, Fuwai HospitalUniversity, hospital or other
- Study start
- 17 Mar 2024 (actual)
- Primary completion
- 30 Sep 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 18 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Evaluate the efficacy of PVI+SVCI guided by quantitative AI.
- Assess the safety of PVI+SVCI guided by quantitative AI.
The primary end point is treatment success at 3 months after the index ablation. The secondary end points include treatment success at 12 months, and safety outcomes.
Detailed description
Catheter ablation has emerged as an effective treatment for drug-refractory PAF and is recommended as first-line therapy by current guidelines. PVI is considered the cornerstone of catheter ablation for atrial fibrillation (AF). However, despite persistent PVI, a subgroup of patients may experience recurrent AF due to focal ectopic discharges originating outside the pulmonary veins. Among the non-pulmonary vein triggers, the SVC stands out as a common culprit, making it a promising ablation target for maintaining sinus rhythm.
Nevertheless, results from previous studies that evaluate the efficacy of SVCI showed conflicting results. One possible explanation is that SVC is adjacent to critical anatomy structures (such as the sinus node and the phrenic nerve), which raises safety concerns and often leads to inadequate ablation.
Therefore, it is necessary to establish standardized ablation procedure for SVCI, ensuring both safety and efficacy. To address this issue, we proposed the concept of "quantitative ablation for SVCI." By introducing AI as a quantitative measure, it is possible to achieve precise catheter ablation while minimizing the risk of procedure-related complications.
The SCORE trial is single-center, prospective, randomized controlled trial aiming to enroll 290 patients with 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 goal is to determine whether quantitative SVCI could improve clinical results for PAF when added to PVI. The key objectives are as follows:
- Evaluate the efficacy of PVI+SVCI guided by quantitative AI.
- Assess the safety of PVI+SVCI guided by quantitative AI.
The primary endpoint of the study is treatment success, defined as freedom from AF, atrial flutter, or atrial tachycardia lasting longer than 30 seconds, at the 3-month follow-up. Secondary endpoints include treatment success at the 12-month follow-up and safety outcomes, including death, stroke/TIA, pericardial tamponade or effusion requiring drainage, pulmonary vein stenosis, superior vena cava stenosis, diaphragmatic nerve injury or paralysis, sinus node dysfunction, and atrial esophageal fistula.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PVI | Active comparator | Procedure: PVIParticipants in this group will receive pulmonary vein isolation. |
| PVI+SVCI | Experimental | Procedure: PVI+ quantitative SVCIParticipants in this group will receive superior vena cava isolation in addition to pulmonary vein isolation. |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PVIpulmonary vein isolation | Procedure or surgery | PVI |
| PVI+ quantitative SVCIpulmonary vein isolation and superior vena cava isolation guided by quantitative ablation index | Procedure or surgery | PVI+SVCI |
Primary outcome
Proportion of patients with maintenance of sinus rhythm measured by 14-day Holter ECG at 3 months follow-up
Time frame: 3 months
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.
2 secondary outcomes
Proportion of patients with maintenance of sinus rhythm measured by 14-day Holter ECG at 12 months follow-up
Time frame: 12 months
Incidence of treatment emergent adverse events post ablation
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2025.
- Background: PubMed 18776706Zhou 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.
- Background: PubMed 30874716Mark 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.
- Background: PubMed 19732237Corrado 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.
- Background: PubMed 24320606Miyazaki 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.
- Background: PubMed 26477712Santangeli 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.
- Background: PubMed 25662699Da 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.
- Background: PubMed 26434513Ejima 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.
- Background: PubMed 27743289Sharma 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.
- Background: PubMed 23128496Higuchi 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.
- Background: PubMed 32305224Zhang 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.
- Background: PubMed 28943481Yamashita 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.
- Background: PubMed 23090663Miyazaki 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.
- Individual participant dataSharing planned: No
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Atrial Fibrillation (AF)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jun Liu, MD, PhD principal investigator
Chinese Academy of Medical Sciences, Fuwai Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PVI and PVI+ quantitative SVCI in people with Atrial Fibrillation, run by Chinese Academy of Medical Sciences, Fuwai 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 3 inclusion and 10 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: looking for participants now, as of the sponsor's last update on 14 Feb 2025. 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?
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?
Contact Wenchi Guan, MD, PhD (+8613521270747, wenchi.guan@outlook.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients with maintenance of sinus rhythm measured by 14-day Holter ECG at 3 months follow-up (time frame: 3 months). 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 NCT05908955, which also lists 13 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 14 Feb 2025.