The Influence of Catheter Ablation for Atrial Fibrillation on Atrial Electrical
1 other identifier
interventional
126
1 country
1
Brief Summary
This study explored the influence of radiofrequency catheter ablation and cryoballoon ablation on atrial electrical remodeling in patients with atrial fibrillation,the relationship between atrial electrical remodeling and structural remodeling,and which indicators are associated with atrial recurrence after catheter ablation.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable atrial-fibrillation
Started Sep 2017
1 active site
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
Study Start
First participant enrolled
September 1, 2017
CompletedFirst Submitted
Initial submission to the registry
September 28, 2017
CompletedFirst Posted
Study publicly available on registry
October 26, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
October 30, 2019
CompletedMarch 18, 2021
March 1, 2020
2.1 years
September 28, 2017
March 17, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Change of P wave
Electrocardiogram
1-12 month
Atrial effective refractory period
Electrophysiological examination
During the operation
Secondary Outcomes (6)
Plasma biomarkers of inflammation assessed
1-12 month
B type natriuretic peptide assessed
1-12 month
Left atrial function
1-12month
Coagulation index assessed
1-6 month
homocysteine assessed
1-12 month
- +1 more secondary outcomes
Study Arms (3)
paroxysmal AF with radiofrequency ablation
EXPERIMENTALradiofrequency catheter ablation therapy
persistent AF with radiofrequency ablation group
EXPERIMENTALradiofrequency catheter ablation therapy
paroxysmal AF with cryoballoon group
EXPERIMENTALcryoballoon ablation therapy
Interventions
Patients in radiofrequency ablation group receive circumferential pulmonary vein isolation,and no additional ablation is performed in the extrapulmonary sites unless the patient is diagnosed with atrial flutter before the operation. And Cryoablation is performed using a single cryoballoon. The diameter of the cryoballoon is determined as 28 mm or 23 mm according to pulmonary venography results.
Eligibility Criteria
You may qualify if:
- paroxysmal AF episode occurs in the patient at least twice within half a year (electrocardiogram data or Holter), AF cannot be prevented in patients who orally take class I and III antiarrhythmic drugs, and patient age is ≤80 years.
You may not qualify if:
- patients with previous history of AF ablation, atrial thrombosis, or valvular heart disease (moderate and severe valvular stenosis, severe valvular regurgitation), left atrium (LA) \>50 mm, patients who underwent prosthetic heart valve replacement, pregnant women, patients with existing liver and kidney disease, malignant tumors or hematological system diseases.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The Second Hospital of Hebei Medical University
Shijiazhuang, Hebei, 050000, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- director of cardiology department
Study Record Dates
First Submitted
September 28, 2017
First Posted
October 26, 2017
Study Start
September 1, 2017
Primary Completion
October 1, 2019
Study Completion
October 30, 2019
Last Updated
March 18, 2021
Record last verified: 2020-03