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

Phase 4

• Conditions: Premature Ventricular Contraction
• Interventions: Procedure: Catheter Ablation

• Registration Number: NCT04519112
• Lead Sponsor: Ruijin Hospital

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2020-08
• Study First Submitted: 2020-08-17
• Study First Submitted QC: 2020-08-18
• Last Update Submitted: 2020-08-18
• Study First Posted: 2020-08-19
• Last Update Posted: 2020-08-19
• Study Start: 2020-10-01
• Primary Completion: 2022-09-30
• Study Completion: 2023-09-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Remote magnetic navigation group	Catheter Ablation	PVC ablation with RMN
Mannual control navigation group	Catheter Ablation	PVC ablation with mannual navigation

Primary Outcome Measures

Name	Time	Method
Freedom rate of PVC	one year	Efficacy endpoint
Procedure-related Complications	one year	Safety endpoint

Secondary Outcome Measures

Name	Time	Method
ablation time	one day
procedure time	one day
fluoroscopic time	one day