Back to resultsAddition of Six Short Lines on Pulmonary Vein Isolation
Primary Purpose
Paroxysmal Atrial Fibrillation
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
PVI
CPVI+6L
Sponsored by
About this trial
This is an interventional treatment trial for Paroxysmal Atrial Fibrillation focused on measuring Paroxysmal Atrial Fibrillation; Ablation
Eligibility Criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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.
- Other significant congenital anomaly or medical problem that in the opinion of the investigator would preclude enrollment
Sites / Locations
- Xinhua Hospital, Shanghai Jiao Tong University School of Medicne
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
PVI
PVI+6L
Arm Description
Pulmonary vein isolation (PVI)
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
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
AF burden
Percentage of time in AF, atrial flutter or atrial tachycardia on 14-days continuous monitoring at 12 months.
Procedural time
Total procedural time from femoral vein puncture to decannulation (skin-to-skin time)
Fluoroscopy time
Time of patients' exposure to the real-time X-ray imaging during the procedure.
Ablation time
Radiofrequency delivery time during the procedure.
Early onset complications
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.
Late onset complications
Complications detected any time during the follow-up, including severe pulmonary vein stenosis (>70%), and atrioesophageal fistula.
Full Information
NCT ID
NCT02637453
First Posted
December 16, 2015
Last Updated
June 10, 2021
Sponsor
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Collaborators
Xuzhou Central Hospital, Shanghai East Hospital, Shanghai Chest Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02637453
Brief Title
Addition of Six Short Lines on Pulmonary Vein Isolation
Official Title
Addition of Six Short Ablation Lines on Pulmonary Vein Isolation Circumferences Reduces Recurrence Rate of Paroxysmal Atrial Fibrillation
Study Type
Interventional
2. Study Status
Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
January 4, 2017 (Actual)
Primary Completion Date
January 10, 2021 (Actual)
Study Completion Date
January 10, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Collaborators
Xuzhou Central Hospital, Shanghai East Hospital, Shanghai Chest Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Paroxysmal Atrial Fibrillation
Keywords
Paroxysmal Atrial Fibrillation; Ablation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
390 (Actual)
8. Arms, Groups, and Interventions
Arm Title
PVI
Arm Type
Active Comparator
Arm Description
Pulmonary vein isolation (PVI)
Arm Title
PVI+6L
Arm Type
Experimental
Arm Description
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
Intervention Type
Procedure
Intervention Name(s)
PVI
Intervention Description
Pulmonary vein isolation
Intervention Type
Procedure
Intervention Name(s)
CPVI+6L
Intervention Description
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
Primary Outcome Measure Information:
Title
Freedom from AF recurrence between 91 and 365 days
Description
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.
Time Frame
91 to 365 days
Secondary Outcome Measure Information:
Title
AF burden
Description
Percentage of time in AF, atrial flutter or atrial tachycardia on 14-days continuous monitoring at 12 months.
Time Frame
12 months
Title
Procedural time
Description
Total procedural time from femoral vein puncture to decannulation (skin-to-skin time)
Time Frame
Within procedure
Title
Fluoroscopy time
Description
Time of patients' exposure to the real-time X-ray imaging during the procedure.
Time Frame
Within procedure
Title
Ablation time
Description
Radiofrequency delivery time during the procedure.
Time Frame
Within procedure
Title
Early onset complications
Description
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.
Time Frame
Within 30 days
Title
Late onset complications
Description
Complications detected any time during the follow-up, including severe pulmonary vein stenosis (>70%), and atrioesophageal fistula.
Time Frame
within 12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria
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.
Exclusion criteria
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.
Other significant congenital anomaly or medical problem that in the opinion of the investigator would preclude enrollment
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yi-Gang Li, MD.
Organizational Affiliation
Department of Cardiology, Xinhua Hospital, Shanghai Jiaotong University School of Medicne
Official's Role
Principal Investigator
Facility Information:
Facility Name
Xinhua Hospital, Shanghai Jiao Tong University School of Medicne
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200092
Country
China
12. IPD Sharing Statement
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Addition of Six Short Lines on Pulmonary Vein Isolation
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