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

• 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

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