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Addition of Six Short Lines on Pulmonary Vein Isolation

NCT02637453 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 390

Last updated 2021-06-15

No results posted yet for this study

Summary

We randomly assigned 390 patients with symptomatic, paroxysmal AF to undergo catheter ablation with PVI (PVI group) alone or combined with 6 additional ablation lines extended outside the PVI circumferences at 1, 3 and 6 o'clock of left PV and 6, 9 and 11 o'clock of right PV (PVI+6L group). Patients received monthly 12-lead electrocardiogram, 24-hour Holter at 3, 6 and 9 months and 14-days continuous monitoring at 12 months to detect atrial tachyarrhythmia. The follow-up period was 12 months. The primary end point was freedom from AF recurrence between 91 and 365 days after catheter ablation. The secondary end points included the AF burden, procedural parameters, and complications.

Conditions

  • Paroxysmal Atrial Fibrillation

Interventions

PROCEDURE

PVI

Pulmonary vein isolation

PROCEDURE

CPVI+6L

After PVI, 6 ablation lines were added with an extension from pulmonary vein ostium at 1, 3 and 6 o'clock (from internal view) of left PV and 6, 9 and 11 o'clock of right PV

Sponsors & Collaborators

  • Xuzhou Central Hospital

    collaborator OTHER

  • Shanghai East Hospital

    collaborator OTHER

  • Shanghai Chest Hospital

    collaborator OTHER

  • Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

    lead OTHER

Principal Investigators

  • Yi-Gang Li, MD. · Department of Cardiology, Xinhua Hospital, Shanghai Jiaotong University School of Medicne

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2017-01-04
Primary Completion
2021-01-10
Completion
2021-01-10

Countries

  • China

Study Locations

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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 NCT02637453 on ClinicalTrials.gov