Addition of Six Short Lines on Pulmonary Vein Isolation

June 10, 2021 updated by: Yi-Gang Li, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Addition of Six Short Ablation Lines on Pulmonary Vein Isolation Circumferences Reduces Recurrence Rate of Paroxysmal Atrial Fibrillation

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

390

Phase

  • Not Applicable

Contacts and Locations

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

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200092
        • Xinhua Hospital, Shanghai Jiao Tong University School of Medicne

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 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion criteria

  1. Patients between the ages of 18 and 80 years undergoing their first ablation of atrial fibrillation.
  2. Diagnosed with symptomatic paroxysmal atrial fibrillation, defined as an documented episode of atrial fibrillation that lasts more than 30 seconds and terminates in less than 7 days.
  3. Resistant or intolerant to at least one class I, II, or III antiarrhythmic drugs.
  4. Patients deemed candidates for radiofrequency ablation of atrial fibrillation.
  5. Able and willing to comply with pre-, post-, and follow-up requirements.

Exclusion criteria

  1. Left atrial thrombus by pre-procedural imaging.
  2. Uncontrolled heart failure: New York Heart Association Class III or IV, or left ventricular ejection fraction< 40%
  3. Myocardial infarction, unstable angina, coronary stenting within the previous 90 days.
  4. Stroke or any thrombo-embolic events within the previous 90 days.
  5. Expecting cardiac transplantation or other cardiac surgery within 180 days.
  6. History of catheter ablation of atrial fibrillation, atrial flutter or atrial tachycardia.
  7. History of blood clotting or bleeding abnormalities.
  8. Contraindication to anticoagulation.
  9. History of cardiac surgery.
  10. Uncontrolled maligment tumor.
  11. Patients in dialysis or creatinine > 221 μmol/L.
  12. Patients with alanine aminotransferase > 150 U/L or aspartate aminotransferase > 76 U/L
  13. Acute illness or active infection at time of index procedure or leukocytosis for which antibiotics have been or will be prescribed.
  14. Life expectancy less than 1 year.
  15. Women who are pregnant or who plan to become pregnant during the study.
  16. Other significant congenital anomaly or medical problem that in the opinion of the investigator would preclude enrollment

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 Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: PVI
Pulmonary vein isolation (PVI)
Procedure: PVI
Pulmonary vein isolation
Experimental: PVI+6L
PVI plus 6 additional lines at 1, 3 and 6 o'clock (from internal view) of left PV and 6, 9 and 11 o'clock of right PV
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Freedom from AF recurrence between 91 and 365 days
Time Frame: 91 to 365 days
AF recurrence was defined by AF (including atrial flutter or atrial tachycardia) of 30 seconds or more captured by ECG monitoring or any clinical presentation with AF outside the 90-day blanking period (between 91 and 365 days). Cardioversion, or use of class I or III antiarrhythmic drugs outside blanking period was also considered as AF recurrence.
91 to 365 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
AF burden
Time Frame: 12 months
Percentage of time in AF, atrial flutter or atrial tachycardia on 14-days continuous monitoring at 12 months.
12 months
Procedural time
Time Frame: Within procedure
Total procedural time from femoral vein puncture to decannulation (skin-to-skin time)
Within procedure
Fluoroscopy time
Time Frame: Within procedure
Time of patients' exposure to the real-time X-ray imaging during the procedure.
Within procedure
Ablation time
Time Frame: Within procedure
Radiofrequency delivery time during the procedure.
Within procedure
Early onset complications
Time Frame: Within 30 days
Complications within 30 days post-ablation, including death, myocardial infarction, diaphragmatic paralysis, stroke or transient ischemic attack, systemic embolism, pericardial effusion or tamponade requiring drainage, heart block, pericarditis, and vascular access complications requiring intervention.
Within 30 days
Late onset complications
Time Frame: within 12 months
Complications detected any time during the follow-up, including severe pulmonary vein stenosis (>70%), and atrioesophageal fistula.
within 12 months

Collaborators and Investigators

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

Sponsor

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Collaborators

Shanghai Chest Hospital
Xuzhou Central Hospital
Shanghai East Hospital

Investigators

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

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 (Actual)

January 4, 2017

Primary Completion (Actual)

January 10, 2021

Study Completion (Actual)

January 10, 2021

Study Registration Dates

First Submitted

December 16, 2015

First Submitted That Met QC Criteria

December 17, 2015

First Posted (Estimate)

December 22, 2015

Study Record Updates

Last Update Posted (Actual)

June 15, 2021

Last Update Submitted That Met QC Criteria

June 10, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ShanghaiXinhua-Af

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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