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| Name | Class |
|---|---|
| Abbott | INDUSTRY |
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Background. Atrial fibrillation (AF) is a disorganised rhythm of the upper chambers of the heart. It can lead to severe complications including stroke or heart failure. It can be treated with radiofrequency ablation (RFA). This technology works by heating heart muscle inside the heart to break the electrical circuits responsible for the abnormal rhythm.
The energy is delivered into the heart with plastic tubes that have metal electrodes, inserted through the groin veins and removed after the procedure. The patient is usually put to sleep during the intervention.
If the AF has been present for more than seven days but for less than one year it is called persistent, and it can be difficult to treat successfully with the usual methods.
Goals. The study will test a new RFA technique to treat patients with persistent AF. This involves identifying areas within the left upper chamber that have a lower electrical voltage than the surrounding heart muscle and applying RFA to the border zones of these areas.
Methods. The new technology combined with the usual procedure will be compared to the usual procedure alone. All patients will receive ablation according to the new technique and results will be compared to a historical control group from the trial institution.
Follow up. Patients will be followed up for 12 months with clinic visits and heart rhythm checks.
Potential benefit. The new technique will be assessed for success at keeping patients free from persistent AF compared to the usual methods.
The study will be performed at Imperial College Healthcare NHS Trust, at the Hammersmith Hospital. Licensed clinical software will be used from St Jude Medical to guide ablation and a special research software module will be used to analyse data from the heart following ablation. The study will be sponsored by Imperial College Healthcare NHS Trust
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pulmonary Vein Isolation | Active Comparator | Historical control from cases performed in year 2017 at Hammersmith Hospital. Intervention: Pulmonary vein isolation. |
|
| Low voltage ablation | Experimental | Active arm, Intervention: Standard pulmonary vein isolation and Low Voltage Ablation. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Low voltage ablation | Procedure | Catheter ablation of low voltage areas in the left atrium and catheter ablation aiming for the electrical isolation of the pulmonary veins. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Atrial fibrillation recurrence | Recurrence of atrial arrhythmia of at least 30s in duration. Investigation period for arrhythmia recurrence will be between 3 and 12 months after the first procedure, allowing for a blanking period of 3 months. | 3-12 months. |
| Measure | Description | Time Frame |
|---|---|---|
| Canadian Cardiovascular Society Severity in Atrial Fibrillation Score | Canadian Cardiovascular Society Severity in Atrial Fibrillation (CCS-SAF) change. 0 represents no symptoms, 4 represents symptoms that significantly interfere with quality of life and exercise capacity. | 12 months |
| Antiarrhythmic drugs |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Szabolcs Nagy, MD | Contact | 447821694566 | s.nagy@nhs.net |
| Name | Affiliation | Role |
|---|---|---|
| Phang B Lim, MB BChir | Imperial College Healthcare NHS Trust | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hammersmith Hospital | Recruiting | London | W12 0HS | United Kingdom |
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| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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| Pulmonary Vein Isolation | Procedure | Catheter ablation aiming for the electrical isolation of the pulmonary veins. |
|
Change in the number of antiarrhythmic drugs per patient |
| 3-12 months |
| Number of AF ablations | Number of additional AF ablations | 3-12 months |
| Complication rate | Number and rate of complications in the study population. | 3-12 months |
| D013568 |
| Pathological Conditions, Signs and Symptoms |