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

Shanghai Jiao Tong University

Status and phase: Unknown; Phase 4

Conditions: Premature Ventricular Contraction

Treatments: Procedure: Catheter Ablation

Study type: Interventional

Funder types: Other

Identifiers

NCT04519112

20200001

Details and patient eligibility

About

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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 2 patient groups

Remote magnetic navigation group

Experimental group

Description:

PVC ablation with RMN

Treatment:

Procedure: Catheter Ablation

Mannual control navigation group

Active Comparator group

Description:

PVC ablation with mannual navigation

Treatment:

Procedure: Catheter Ablation