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Mesh-type flexible tip (MFT) catheter is developed to generate bigger radiofrequency (RF) lesion, and contract force (CF) catheter improves the maintenance of catheter-tissue contact during atrial fibrillation catheter ablation (AFCA).
The investigators compared clinical outcome of AFCA conducted by MFT catheter and CF catheter in prospective randomized manner.
The investigators prospectively assigned 230 patients with AF in a 1:1 ratio to ablation by MFT catheter (FlexAbilityâ„¢, Abbott Inc. USA) and CF catheter (TactiCathâ„¢, Abbott Inc. USA). The primary end point was AF recurrence after single procedure, and the secondary end point was response to antiarrhythmic drugs.
A. Study design
B. Progress and rhythm/ECG follow-up
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FlexAbility (Mesh-like irrigated tip catheter) group | Active Comparator |
| |
| TactiCath (Contract force monitoring catheter) group | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FlexAbility (Mesh-like irrigated tip catheter) group | Procedure |
|
| Measure | Description | Time Frame |
|---|---|---|
| procedure related complication rate - open heart surgery, stroke, pericardial tamponade, groin complication, and other procedure related complications within a month | 1 month after the procedure | |
| clinical recurrence rate of AF or AT lasting > 30s. Regular rhythm follow-up based on 2012 ACC/AHA/HRS guidelines | 12 months after the procedure | |
| clinical recurrence rate of AF or AT lasting > 30s. Regular rhythm follow-up based on 2012 ACC/AHA/HRS guidelines | 24 months after the procedure | |
| Major cardiovascular events - death, myocardial infarction, coronary angioplasty, stroke, arrhythmia or heart failure related admission | 12 months after the procedure | |
| Major cardiovascular events - death, myocardial infarction, coronary angioplasty, stroke, arrhythmia or heart failure related admission | 24 months after the procedure |
| Measure | Description | Time Frame |
|---|---|---|
| procedure time | intraoperative | |
| RF energy delivery time | within 30 minutes after the procedure | |
| volume of irrigated saline infusion |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Severance Cardiovascular Hospital, Yonsei University Health System | Seoul | South Korea |
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|
| TactiCath (Contract force monitoring catheter) group | Procedure |
|
|
| within 30 minutes after the procedure |
| post-procedural readmission rate | 12 months after the procedure |
| post-procedural readmission rate | 24 months after the procedure |
| post-procedural cardioversion rate | 12 months after the procedure |
| post-procedural cardioversion rate | 24 months after the procedure |
| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D044382 | Population Groups |
| ID | Term |
|---|---|
| D003710 | Demography |
| D011154 | Population Characteristics |
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