Back to resultsLeft Atrial Isolation by Catheter Ablation in Persistent Atrial Fibrillation With Severe Atrial Fibrosis
Primary Purpose
Persistent Atrial Fibrillation
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Left atrial isolation by catheter ablation
Sponsored by
About this trial
This is an interventional treatment trial for Persistent Atrial Fibrillation focused on measuring Persistent Atrial Fibrillation, Severe atrial fibrosis, Left atrial isolation, catheter ablation
Eligibility Criteria
Inclusion Criteria:
- Aged 18 to 80 years old
- Persistent AF with severe atrial fibrosis and left atrial anterioposterior diameter > 50mm
- Nonresponse or intolerance to ≥1 antiarrhythmic drug
- CHA2DS2-VASc ≥ 3 and HAS-BLED < 3
Exclusion Criteria:
- With uncontrolled congestive heart failure;
- Having significant valvular disease;
- Having moderate-to-severe pulmonary hypertension;
- With myocardial infarction or stroke within 6 months of screening;
- With Significant congenital heart disease;
- Ejection fraction was <40% measured by echocardiography;
- Allergic to contrast media;
- Contraindication to anticoagulation medications;
- Severe pulmonary disease e.g. restrictive pulmonary disease, chronic obstructive disease (COPD);
- Left atrial thrombus;
- Having any contraindication to right or left sided heart catheterization
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Left atrial isolation arm
Arm Description
All the enrolled subjects will receive left atrial isolation through catheter ablation.
Outcomes
Primary Outcome Measures
Postoperative atrial fibrillation (AF)/atrial flutter (AFL)/atrial tachycardia (AT) recurrence rate
AF/AFL/AT recurrence is defined as presence of documented AF/AFL/AT episodes of 30 seconds or longer duration
Secondary Outcome Measures
Postoperative AF recurrence rate
AF recurrence is defined as presence of documented AF episodes of 30 seconds or longer duration
Postoperative AFL/AT rate
Occurrence of AFL/AT is defined as presence of documented AFL/AT episodes of 30 seconds or longer duration
Incidence of complications
including death, atrio-esophageal fistula, cardiac tamponade/perforation, myocardial infarction, stroke/cerebrovascular accident, thromboembolism, diaphragmatic paralysis, pneumothorax, pleural effusion, heart block, pulmonary vein stenosis, pulmonary edema, left atrial thrombus, pericarditis and major vascular access complication or bleeding
Changes in the diameter of the left atrium and the left ventricular ejection fraction
Full Information
NCT ID
NCT05173779
First Posted
December 14, 2021
Last Updated
August 9, 2022
Sponsor
Shanghai Chest Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05173779
Brief Title
Left Atrial Isolation by Catheter Ablation in Persistent Atrial Fibrillation With Severe Atrial Fibrosis
Official Title
A Single-arm Study to Evaluate the Efficacy and Safety of Left Atrial Isolation Achieved by Catheter Ablation in Patients With Persistent Atrial Fibrillation and Severe Atrial Fibrosis: a Chinese Registry Study
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
January 1, 2023 (Anticipated)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shanghai Chest Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
This is a single-arm clinical trial evaluating the efficacy and safety of left atrial isolation achieved by catheter ablation in patients with persistent atrial fibrillation with severe atrial fibrosis.
Detailed Description
This is a single-arm clinical trial. Patients with persistent atrial fibrillation with severe atrial fibrosis are enrolled as subjects to conduct left atrial isolation by catheter ablation. Postoperative recurrence rate and other indicators are analyzed to evaluate the efficacy and safety of left atrial isolation achieved by catheter ablation in patients with persistent atrial fibrillation with severe atrial fibrosis.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Persistent Atrial Fibrillation
Keywords
Persistent Atrial Fibrillation, Severe atrial fibrosis, Left atrial isolation, catheter ablation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Left atrial isolation arm
Arm Type
Experimental
Arm Description
All the enrolled subjects will receive left atrial isolation through catheter ablation.
Intervention Type
Procedure
Intervention Name(s)
Left atrial isolation by catheter ablation
Intervention Description
Procedure: Right pulmonary vein circumferential isolation + anterior left atrial line (superior mitral annulus to right superior pulmonary vein via the anterior wall) + para-septal line (para-septal mitral annulus to the right inferior pulmonary vein, including right atrial components-especially in and around the proximal coronary sinus) + posterior left atrial line (superior mitral annulus to right superior pulmonary vein via the posterior wall).
Primary Outcome Measure Information:
Title
Postoperative atrial fibrillation (AF)/atrial flutter (AFL)/atrial tachycardia (AT) recurrence rate
Description
AF/AFL/AT recurrence is defined as presence of documented AF/AFL/AT episodes of 30 seconds or longer duration
Time Frame
up to 18 months after enrollment
Secondary Outcome Measure Information:
Title
Postoperative AF recurrence rate
Description
AF recurrence is defined as presence of documented AF episodes of 30 seconds or longer duration
Time Frame
up to 18 months after enrollment
Title
Postoperative AFL/AT rate
Description
Occurrence of AFL/AT is defined as presence of documented AFL/AT episodes of 30 seconds or longer duration
Time Frame
up to 18 months after enrollment
Title
Incidence of complications
Description
including death, atrio-esophageal fistula, cardiac tamponade/perforation, myocardial infarction, stroke/cerebrovascular accident, thromboembolism, diaphragmatic paralysis, pneumothorax, pleural effusion, heart block, pulmonary vein stenosis, pulmonary edema, left atrial thrombus, pericarditis and major vascular access complication or bleeding
Time Frame
up to 18 months after enrollment
Title
Changes in the diameter of the left atrium and the left ventricular ejection fraction
Time Frame
up to 18 months after enrollment
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:
Aged 18 to 80 years old
Persistent AF with severe atrial fibrosis and left atrial anterioposterior diameter > 50mm
Nonresponse or intolerance to ≥1 antiarrhythmic drug
CHA2DS2-VASc ≥ 3 and HAS-BLED < 3
Exclusion Criteria:
With uncontrolled congestive heart failure;
Having significant valvular disease;
Having moderate-to-severe pulmonary hypertension;
With myocardial infarction or stroke within 6 months of screening;
With Significant congenital heart disease;
Ejection fraction was <40% measured by echocardiography;
Allergic to contrast media;
Contraindication to anticoagulation medications;
Severe pulmonary disease e.g. restrictive pulmonary disease, chronic obstructive disease (COPD);
Left atrial thrombus;
Having any contraindication to right or left sided heart catheterization
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mu Qin, M.D.
Phone
+8613052320103
Email
qinmuae@163.com
12. IPD Sharing Statement
Learn more about this trial
Left Atrial Isolation by Catheter Ablation in Persistent Atrial Fibrillation With Severe Atrial Fibrosis
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