Addition of Six Short Lines on Pulmonary Vein Isolation

NCT02637453 | Completed DMC

• 1 other identifier: ShanghaiXinhua-Af
• Study Type: interventional
• Target: 390
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Paroxysmal Atrial Fibrillation; Ablation

Outcome Measures

Primary Outcomes (1)

• Freedom from AF recurrence between 91 and 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 Outcomes (6)

• AF burden

  12 months

• Procedural time

  Within procedure

• Fluoroscopy time

  Within procedure

• Ablation time

  Within procedure

• Early onset complications

  Within 30 days

Study Arms (2)

PVI

ACTIVE COMPARATOR

Pulmonary vein isolation (PVI)

Procedure: PVI

PVI+6L

EXPERIMENTAL

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

Interventions

PVI PROCEDURE

Pulmonary vein isolation

PVI

CPVI+6L PROCEDURE

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

PVI+6L

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients between the ages of 18 and 80 years undergoing their first ablation of atrial fibrillation.
• 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.
• Resistant or intolerant to at least one class I, II, or III antiarrhythmic drugs.
• Patients deemed candidates for radiofrequency ablation of atrial fibrillation.
• Able and willing to comply with pre-, post-, and follow-up requirements.

You may not qualify if:

• Left atrial thrombus by pre-procedural imaging.
• Uncontrolled heart failure: New York Heart Association Class III or IV, or left ventricular ejection fraction\< 40%
• Myocardial infarction, unstable angina, coronary stenting within the previous 90 days.
• Stroke or any thrombo-embolic events within the previous 90 days.
• Expecting cardiac transplantation or other cardiac surgery within 180 days.
• History of catheter ablation of atrial fibrillation, atrial flutter or atrial tachycardia.
• History of blood clotting or bleeding abnormalities.
• Contraindication to anticoagulation.
• History of cardiac surgery.
• Uncontrolled maligment tumor.
• Patients in dialysis or creatinine \> 221 μmol/L.
• Patients with alanine aminotransferase \> 150 U/L or aspartate aminotransferase \> 76 U/L
• Acute illness or active infection at time of index procedure or leukocytosis for which antibiotics have been or will be prescribed.
• Life expectancy less than 1 year.
• Women who are pregnant or who plan to become pregnant during the study.

Sponsors & Collaborators

• Xinhua Hospital, Shanghai Jiao Tong University School of Medicine: lead
• Xuzhou Central Hospital: collaborator
• Shanghai East Hospital: collaborator
• Shanghai Chest Hospital: collaborator

Study Sites (1)

Xinhua Hospital, Shanghai Jiao Tong University School of Medicne

Shanghai, Shanghai Municipality, 200092, China

Location

Related Publications (12)

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  PMID: 23973694 BACKGROUND

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MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Yi-Gang Li, MD.

  Department of Cardiology, Xinhua Hospital, Shanghai Jiaotong University School of Medicne

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 16, 2015
• First Posted: December 22, 2015
• Study Start: January 4, 2017
• Primary Completion: January 10, 2021
• Study Completion: January 10, 2021
• Last Updated: June 15, 2021

Record last verified: 2021-04

Locations

CN (1)