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| Name | Class |
|---|---|
| Biosense Webster, Inc. | INDUSTRY |
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The study evaluates whether catheter based radiofrequency ablation is superior to optimized antiarrhythmic medical therapy in preventing ventricular tachyarrhythmia relapses in patients with ischemic heart disease and implantable cardioverter defibrillator.
The study is designed to evaluate whether catheter based radiofrequency ablation is superior to optimized antiarrhythmic medical therapy in preventing ventricular tachyarrhythmia relapses among patients with prior myocardial infarction and implantable cardioverter defibrillator (ICD). The patients have not been using using chronic antiarrhythmic medication. Primary end point is number of ICD therapies (defibrillations, cardioversions and antitachycardia pacing) and otherwise documented sustained ventricular tachycardia (duration more than 30 s or hemodynamically unstable ) or ventricular fibrillation episodes during 12 months follow-up period. Secondary end points include mortality, hospitalization for cardiac reason, health economics, quality of life and several ICD and arrhythmia related issues. Total length of the follow-up is at least two years.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Radiofrequency catheter ablation | Experimental | Radiofrequency catheter ablation using open-irrigated ablation catheter and 3D electroanatomical mapping |
|
| Antiarrhythmic drug therapy | Active Comparator | Amiodarone (or sotalol) tablet by mouth for the duration of the study |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Radiofrequency catheter ablation | Procedure | Catheter ablation with an open-irrigated tip ablation catheter and 3D electroanatomical mapping |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of ventricular tachycardia (VT) or ventricular fibrillation (VF) episodes | • Number of appropriate ICD therapies (defibrillation, cardioversion, antitachycardia pacing) for VT/VF and otherwise documented sustained VT or VF episodes at 12 months | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| All cause mortality | 12 and 24 months | |
| Cardiovascular mortality | 12 and 24 months | |
| Time to first hospitalization and number of hospital days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Pekka Raatikainen, MD, PhD | Contact | +358503169001 | pekka.raatikainen@ksshp.fi |
| Name | Affiliation | Role |
|---|---|---|
| Pekka Raatikainen, MD PhD | Keski-Suomen sairaanhoitopiiri | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Central Finland Central Hospital | Recruiting | Jyväskylä | Finland | |||
| Heart Center Tampere University Hospital |
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| Antiarrhythmic drug therapy | Drug | Amiodarone (or sotalol) for prevention of VT/VF relapses |
|
|
| 12 and 24 months |
| Comparative cost-effectiveness of the therapies | 12 and 24 months |
| Quality of life measured By SF-36 and EQ5D questionnaires | 12 and 24 months |
| Patient related outcome measured by the PHQ-9, GAD-7, ICDC-8 and EXPECT-ICD questionnaires | 12 and 24 months |
| Number of appropriate ICD therapies and sustained VT/VF episodes | 24 months |
| Number of non-sustained VT episodes | 12 and 24 months |
| Number of electrical storm episodes | 12 and 24 months |
| Time to first VT/VF | up to 24 months |
| Time to reablation | up to 24 months |
| Number of inappropriate ICD therapies | up to 24 months |
| Number of atrial fibrillation and other supraventricular arrhythmia episodes | up to 24 months |
| Recruiting |
| Tampere |
| Finland |
|
| ID | Term |
|---|---|
| D009203 | Myocardial Infarction |
| D017180 | Tachycardia, Ventricular |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
| D007238 | Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |
| D013610 | Tachycardia |
| D001145 | Arrhythmias, Cardiac |
| D000075224 | Cardiac Conduction System Disease |
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| ID | Term |
|---|---|
| D017115 | Catheter Ablation |
| D000638 | Amiodarone |
| D013015 | Sotalol |
| ID | Term |
|---|---|
| D000078703 | Radiofrequency Ablation |
| D000078702 | Radiofrequency Therapy |
| D013812 | Therapeutics |
| D055011 | Ablation Techniques |
| D013514 | Surgical Procedures, Operative |
| D001572 | Benzofurans |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D000588 | Amines |
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