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Ablation of Paroxysmal Atrial Fibrillation Using the Appropriate Contact Force in a Chinese Population

NCT02493075 · Status: UNKNOWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 140

Last updated 2015-07-09

No results posted yet for this study

Summary

The objective of the study is:Phase I: To validate or otherwise determine the Chinese-specific appropriate contact force during PVI in PAF.Phase II: To evaluate the effectiveness and safety of ablation guided by the appropriate contact force.

Conditions

Interventions

BEHAVIORAL

The operator blinded to the contact force data or not.

CF guided group: ablation will be performed with the guidance of real-time CF, ablation time, FTI, etc. CF will be controlled in the range of "appropriate CF", which has been defined in phase I. Circumferential PV ablation will be performed orderly, "isolated segment"," acute reconnected segment ", and "unisolated segment" will be also identified as described in phase I. Usual ablation group: Operator will be blinded to CF data, the procedure performance is the same as described in phase I.

Sponsors & Collaborators

  • Biosense Webster, Inc.

    collaborator INDUSTRY

  • Sir Run Run Shaw Hospital

    lead OTHER

Principal Investigators

  • Chenyang Jiang, MD · Sir Run Run Shaw Hospital

Study Design

Allocation
RANDOMIZED
Purpose
SCREENING
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-03-31
Primary Completion
2018-01-31
Completion
2018-06-30

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02493075 on ClinicalTrials.gov