Remote Magnetic Versus Manual Navigation-guided Ablation for Non-outflow Tract Premature Ventricular Contractions: a Prospective, Randomized, Controlled Trial

NCT ID: NCT04519112

Last Updated: 2020-08-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-10-01

Study Completion Date

2023-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Premature Ventricular Contraction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Remote magnetic navigation group

PVC ablation with RMN

Group Type EXPERIMENTAL

Catheter Ablation

Intervention Type PROCEDURE

Catheter Ablation with RMN and MCN

Mannual control navigation group

PVC ablation with mannual navigation

Group Type ACTIVE_COMPARATOR

Catheter Ablation

Intervention Type PROCEDURE

Catheter Ablation with RMN and MCN

Interventions

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Catheter Ablation

Catheter Ablation with RMN and MCN

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

1. non-outflow tract PVCs
2. Holter\>10,000/24h or PVCs load\>10%
3. the first ablation procedure
4. failure of at least one AAD to treat PVCs before ablation

Exclusion Criteria

1. PVC ablation history
2. HF with NYHA IV
3. 3 months prior to AMI or PCI
4. Cardiac thrombosi
5. Hyperthyroidism
6. Pregnancy
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ruijin Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Central Contacts

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Qi Jin, MD

Role: CONTACT

+8613020144766

References

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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.

Reference Type RESULT
PMID: 32413467 (View on PubMed)

Qiu 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.

Reference Type RESULT
PMID: 29957265 (View on PubMed)

Other Identifiers

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20200001

Identifier Type: -

Identifier Source: org_study_id

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