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

Premature Ventricular Contraction Clinical Trial

Official title:

Department of Cardiology, Shanghai Ruijin Hospital, Shanghai Jiao Tong University School of Medicine

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04519112
• Other study ID #: 20200001
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: October 1, 2020
• Est. completion date: September 30, 2023

Study information

• Verified date: August 2020
• Source: Ruijin Hospital
• Contact: Qi Jin, MD
• Phone: +8613020144766
• Email: jinqi127[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: September 30, 2023
• Est. primary completion date: September 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Premature Birth
• Premature Ventricular Contraction
• Ventricular Premature Complexes

Intervention

Procedure:
• Catheter Ablation
Catheter Ablation with RMN and MCN

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Ruijin Hospital

References & 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- — View Citation

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 compa — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Freedom rate of PVC	Efficacy endpoint	one year
Primary	Procedure-related Complications	Safety endpoint	one year
Secondary	fluoroscopic time		one day
Secondary	ablation time		one day
Secondary	procedure time		one day