High-density Mapping-guided bOx Isolation and subsTrate Ablation
HOT
Study of High-density Mapping-guided bOx Isolation and subsTrate Ablation for Persistent Atrial Fibrillation
1 other identifier
interventional
200
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable atrial-fibrillation
Started Aug 2019
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 25, 2019
CompletedFirst Posted
Study publicly available on registry
June 26, 2019
CompletedStudy Start
First participant enrolled
August 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 31, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
August 31, 2021
CompletedJuly 1, 2019
June 1, 2019
2.1 years
June 25, 2019
June 28, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
sinus rhythm maintenance rate
Holter is performed 12months after the procedure and heart rhythm is recorded.
12 months
Secondary Outcomes (3)
left ventricular ejection fraction
12 months
Stroke or embolic events
12 months
Atrial fibrosis
1 day
Study Arms (3)
Circumferential PV isolation
ACTIVE COMPARATORCircumferential PV isolation only
Circumferential PV and BOX isolation
EXPERIMENTALCircumferential PV and BOX isolation
circumferential PV and BOX isolation with substrate ablation
EXPERIMENTALAtrial substrate ablation apart from circumferential PV and BOX isolation
Interventions
Atrial substrate ablation apart from circumferential PV and BOX isolation
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, CARE PROVIDER
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 25, 2019
First Posted
June 26, 2019
Study Start
August 1, 2019
Primary Completion
August 31, 2021
Study Completion
August 31, 2021
Last Updated
July 1, 2019
Record last verified: 2019-06