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

August 18, 2020 updated by: Ruijin Hospital

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

200

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Remote magnetic navigation group
PVC ablation with RMN
Procedure: Catheter Ablation
Catheter Ablation with RMN and MCN
ACTIVE_COMPARATOR: Mannual control navigation group
PVC ablation with mannual navigation
Procedure: Catheter Ablation
Catheter Ablation with RMN and MCN

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Freedom rate of PVC
Time Frame: one year
Efficacy endpoint
one year
Procedure-related Complications
Time Frame: one year
Safety endpoint
one year

Secondary Outcome Measures

Outcome Measure
Time Frame
fluoroscopic time
Time Frame: one day
one day
ablation time
Time Frame: one day
one day
procedure time
Time Frame: one day
one day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ruijin Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

October 1, 2020

Primary Completion (ANTICIPATED)

September 30, 2022

Study Completion (ANTICIPATED)

September 30, 2023

Study Registration Dates

First Submitted

August 17, 2020

First Submitted That Met QC Criteria

August 18, 2020

First Posted (ACTUAL)

August 19, 2020

Study Record Updates

Last Update Posted (ACTUAL)

August 19, 2020

Last Update Submitted That Met QC Criteria

August 18, 2020

Last Verified

August 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20200001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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