High-density Mapping-guided bOx Isolation and subsTrate Ablation (HOT)
Primary Purpose
Atrial Fibrillation, Atrial Remodeling
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
CPVI
CPVI+BOX
CPVI+BOX+SUB
Sponsored by
About this trial
This is an interventional treatment trial for Atrial Fibrillation focused on measuring catheter ablation
Eligibility Criteria
Inclusion Criteria:
- Informed consent signed.
- Age of 18 to 75 years old.
- Persistent or longstanding persistent atrial fibrillation (≥7 days), which is confirmed by Holter in recent six months.
- Willing to have catheter ablation for atrial fibrillation.
Exclusion Criteria:
- Accompanied by serious heart diseases including cardiac valvular diseases, congenital heart diseases, hypertrophic obstructive cardiomyopathy, acute myocardium infarction, unstable anginal pectoris and so on.
- Complete atrioventricular block.
- An acute stroke or contradiction of anti-coagulation.
- Hyperthyroidism.
- Having a history of catheter ablation of atrial fibrillation.
- Left atrial appendage thrombosis confirmed by transesophageal echocardiography.
- Pregnancy or lactation.
- Planning for pregnancy in the near future.
- Myopathy or active liver disease, including patients with sustained increase of serum transaminase of unknown reason and the ones with increased serum transaminase over three times the upper limit of normal.
- Patients of severe renal insufficiency with creatinine clearance lower than 30 ml/min.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Experimental
Experimental
Arm Label
Circumferential PV isolation
Circumferential PV and BOX isolation
circumferential PV and BOX isolation with substrate ablation
Arm Description
Circumferential PV isolation only
Circumferential PV and BOX isolation
Atrial substrate ablation apart from circumferential PV and BOX isolation
Outcomes
Primary Outcome Measures
sinus rhythm maintenance rate
Holter is performed 12months after the procedure and heart rhythm is recorded.
Secondary Outcome Measures
left ventricular ejection fraction
LVEF is evaluated by echocardiography 12months after the procedure.
Stroke or embolic events
History of stroke or embolic events is taken at each follow-up during the period of 12 months after procedure, and if necessary, radiographic examinations will be performed.
Atrial fibrosis
Atrial substrate mapping is performed before and after catheter ablation in one day to evaluate the atrial fibrosis.
Full Information
NCT ID
NCT03998956
First Posted
June 25, 2019
Last Updated
June 28, 2019
Sponsor
The Third Xiangya Hospital of Central South University
1. Study Identification
Unique Protocol Identification Number
NCT03998956
Brief Title
High-density Mapping-guided bOx Isolation and subsTrate Ablation
Acronym
HOT
Official Title
Study of High-density Mapping-guided bOx Isolation and subsTrate Ablation for Persistent Atrial Fibrillation
Study Type
Interventional
2. Study Status
Record Verification Date
June 2019
Overall Recruitment Status
Unknown status
Study Start Date
August 1, 2019 (Anticipated)
Primary Completion Date
August 31, 2021 (Anticipated)
Study Completion Date
August 31, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The Third Xiangya Hospital of Central South University
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 study evaluates the efficacy of high-density mapping guided atrial substrate ablation for persistent atrial fibrillation. 1/5 of the patients with persistent atrial fibrillation undergo pulmonary veins isolation, 2/5 of them pulmonary veins and box isolation while others undergo atrial substrate ablation apart from pulmonary veins and box isolation.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation, Atrial Remodeling
Keywords
catheter ablation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Circumferential PV isolation
Arm Type
Active Comparator
Arm Description
Circumferential PV isolation only
Arm Title
Circumferential PV and BOX isolation
Arm Type
Experimental
Arm Description
Circumferential PV and BOX isolation
Arm Title
circumferential PV and BOX isolation with substrate ablation
Arm Type
Experimental
Arm Description
Atrial substrate ablation apart from circumferential PV and BOX isolation
Intervention Type
Procedure
Intervention Name(s)
CPVI
Intervention Description
Circumferential PV isolation only
Intervention Type
Procedure
Intervention Name(s)
CPVI+BOX
Intervention Description
Circumferential PV and BOX isolation
Intervention Type
Procedure
Intervention Name(s)
CPVI+BOX+SUB
Intervention Description
Atrial substrate ablation apart from circumferential PV and BOX isolation
Primary Outcome Measure Information:
Title
sinus rhythm maintenance rate
Description
Holter is performed 12months after the procedure and heart rhythm is recorded.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
left ventricular ejection fraction
Description
LVEF is evaluated by echocardiography 12months after the procedure.
Time Frame
12 months
Title
Stroke or embolic events
Description
History of stroke or embolic events is taken at each follow-up during the period of 12 months after procedure, and if necessary, radiographic examinations will be performed.
Time Frame
12 months
Title
Atrial fibrosis
Description
Atrial substrate mapping is performed before and after catheter ablation in one day to evaluate the atrial fibrosis.
Time Frame
1 day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Informed consent signed.
Age of 18 to 75 years old.
Persistent or longstanding persistent atrial fibrillation (≥7 days), which is confirmed by Holter in recent six months.
Willing to have catheter ablation for atrial fibrillation.
Exclusion Criteria:
Accompanied by serious heart diseases including cardiac valvular diseases, congenital heart diseases, hypertrophic obstructive cardiomyopathy, acute myocardium infarction, unstable anginal pectoris and so on.
Complete atrioventricular block.
An acute stroke or contradiction of anti-coagulation.
Hyperthyroidism.
Having a history of catheter ablation of atrial fibrillation.
Left atrial appendage thrombosis confirmed by transesophageal echocardiography.
Pregnancy or lactation.
Planning for pregnancy in the near future.
Myopathy or active liver disease, including patients with sustained increase of serum transaminase of unknown reason and the ones with increased serum transaminase over three times the upper limit of normal.
Patients of severe renal insufficiency with creatinine clearance lower than 30 ml/min.
12. IPD Sharing Statement
Learn more about this trial
High-density Mapping-guided bOx Isolation and subsTrate Ablation
We'll reach out to this number within 24 hrs