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This study is to assess the effectiveness and safety of cryoballoon ablation comparing with medical therapy in patients with atrial fibrillation and heart failure with different ejection fraction categories.
Subjects with atrial fibrillation and heart failure with different ejection fraction categories are devided to either an anti-arrhythmic drug or cryoballoon catheter ablation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Medical treatment group | Using class I or class III AAD to maintain sinus rhythm |
| |
| Cryoballoon ablation group | Pulmonary vein isolation by cryoballoon ablation using Medtronic Arctic Front Advance⢠Cardiac CryoAblation Catheters (23mm and 28mm) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Antiarrhythmic drug Therapy | Drug | Propafenone, Sotalol and Amiodarone |
|
| Measure | Description | Time Frame |
|---|---|---|
| Treatment success at one year | Treatment success at 12 months after antiarrhythmic drug (AAD) initiation or ablation utilizing cryoballoon catheter measured by freedom from AF recurrence following a 3-month period after the index ablation or AAD initiation. | one year |
| Rate of adverse events | Rate of complications and adverse events occurred during cryoballoon ablation and postoperative follow-up, including all-cause mortality, rehospitalisation for HF, and the composite event of all-cause mortality or HF hospitalisation | one year |
| Measure | Description | Time Frame |
|---|---|---|
| Arrhythmia recurrence during blanking period | atrial tachycardia recurrence | 3 months |
| Quality of life changes at 12 months measured by 12-Item Short Form Survey (SF-12) | The improvement in quality of life between baseline and 12 months after the index ablation procedure or AAD measured by 12-Item Short Form Survey (SF-12) with the values ranging from 12 - 47 (higher scores mean a worse outcome) |
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Inclusion Criteria:
Exclusion Criteria:
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Diagnosed with symptomatic paroxysmal or persistent atrial fibrillationļ¼defined as at least two symptomatic episodes in the last six months prior to enrollment.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Qi Lu, MD | Contact | +8613962989292 | luqint@sina.com | |
| Haixia Xu, MD | Contact | +8615050641838 | ntxhx2005@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Affiliated hospital of Nantong University | Recruiting | Nantong | Jiangsu | 226001 | China |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 8, 2022 | May 2, 2022 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D000889 | Anti-Arrhythmia Agents |
| ID | Term |
|---|---|
| D002317 | Cardiovascular Agents |
| D045506 | Therapeutic Uses |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
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| cryoballoon ablation | Device | Medtronic Arctic Front Advance⢠Cardiac CryoAblation Catheters including 23mm and 28mm. |
|
| one year |
| Quality of life changes at 12 months measured by AF Quality of Life Survey (AFEQT) | The improvement in quality of life between baseline and 12 months after the index ablation procedure or AAD measured by AF Quality of Life Survey (AFEQT) with the values ranging from 20 - 140 (higher scores mean a worse outcome) | one year |