Remote Magnetic Versus Manual Navigation-guided Ablation for Non-outflow Tract Premature Ventricular Contractions: a Prospective, Randomized, Controlled Trial
Department of Cardiology, Shanghai Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
1 other identifier
interventional
200
0 countries
N/A
Brief Summary
This prospective, randomized, controlled trial is designed to compare the safety and efficacy of remote magnetic navigation-guided ablation for ventricular premature complexes arising from non-outflow tracts with manual control navigation.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Oct 2020
Typical duration for phase_4
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 17, 2020
CompletedFirst Posted
Study publicly available on registry
August 19, 2020
CompletedStudy Start
First participant enrolled
October 1, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 30, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
September 30, 2023
CompletedAugust 19, 2020
August 1, 2020
2 years
August 17, 2020
August 18, 2020
Conditions
Outcome Measures
Primary Outcomes (2)
Freedom rate of PVC
Efficacy endpoint
one year
Procedure-related Complications
Safety endpoint
one year
Secondary Outcomes (3)
fluoroscopic time
one day
ablation time
one day
procedure time
one day
Study Arms (2)
Remote magnetic navigation group
EXPERIMENTALPVC ablation with RMN
Mannual control navigation group
ACTIVE COMPARATORPVC ablation with mannual navigation
Interventions
Catheter Ablation with RMN and MCN
Eligibility Criteria
You may qualify if:
- non-outflow tract PVCs
- Holter\>10,000/24h or PVCs load\>10%
- the first ablation procedure
- failure of at least one AAD to treat PVCs before ablation
You may not qualify if:
- PVC ablation history
- HF with NYHA IV
- months prior to AMI or PCI
- Cardiac thrombosi
- Hyperthyroidism
- Pregnancy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Ruijin Hospitallead
Related Publications (2)
Noten AME, Hendriks AA, Yap SC, Mol D, Bhagwandien R, Wijchers S, Kardys I, Khan M, Szili-Torok T. Contact feedback improves 1-year outcomes of remote magnetic navigation-guided ischemic ventricular tachycardia ablation. Int J Cardiol. 2020 Sep 15;315:36-44. doi: 10.1016/j.ijcard.2020.05.028. Epub 2020 May 12.
PMID: 32413467RESULTQiu X, Zhang N, Luo Q, Liu A, Ji Y, Ye J, Lin C, Ling T, Chen K, Pan W, Zhao J, Jin Q, Wu L. Remote magnetic navigation facilitates the ablations of frequent ventricular premature complexes originating from the outflow tract and the valve annulus as compared to manual control navigation. Int J Cardiol. 2018 Sep 15;267:94-99. doi: 10.1016/j.ijcard.2018.03.105.
PMID: 29957265RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 17, 2020
First Posted
August 19, 2020
Study Start
October 1, 2020
Primary Completion
September 30, 2022
Study Completion
September 30, 2023
Last Updated
August 19, 2020
Record last verified: 2020-08
Data Sharing
- IPD Sharing
- Will not share