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This study compares the procedural characteristics and effectivity of radiofrequency ablation and cryoablation in patients with atrial fibrillation that are 75 years or older.
Radiofrequency and cryoballon ablation have been shown to be comparable to each other in terms of safety and effectivity in patients with atrial fibrillation. However, elderly patients have been underrepresented in the previous studies. The number of older patients with atrial fibrillation is high and the number of who undergo an ablation procedure for atrial fibrillation increases steadily. This prospective randomized trial compares the effectivity (recurrency of atrial arrhythmias) and periprocedural characteristics of the two established ablation methods in patients who are 75 years or older.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients over 75 years_RF ablation | Active Comparator | Patients randomized to receive pulmonary vein isolation by means of radiofrequency ablation. |
|
| Patients over 75 years_ballon cryoablation | Active Comparator | Patients randomized to receive pulmonary vein isolation by means of ballon cryoablation. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| radiofrequency ablation | Procedure | ablative treatment as allocated to radiofrequency ablation |
|
| Measure | Description | Time Frame |
|---|---|---|
| atrial arrhythmia recurrence | Number of Participants with recurrence of any atrial arrhythmia with a duration of 30 sec or longer 12 months after the ablative treatment | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| procedural duration | Duration of the whole procedure [min] inclusive preparation (from entrance to the EP lab till exit from the EP lab) | periprocedural |
| time to wake-up after propofol withdrawal |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Charalampos Kriatselis, MD | Contact | 0049 30 15140663741 | charalampos.kriatselis@vivantes.de | |
| Michael Distler, MD | Contact | 0049 30 130 142014 | michael.distler@vivantes.de |
| Name | Affiliation | Role |
|---|---|---|
| Charalampos Kriatselis, MD | Vivantes Clinic Neukölln | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vivantes Klinikum Neukölln | Recruiting | Berlin | Germany |
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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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| ID | Term |
|---|---|
| D000078703 | Radiofrequency Ablation |
| ID | Term |
|---|---|
| D000078702 | Radiofrequency Therapy |
| D013812 | Therapeutics |
| D055011 | Ablation Techniques |
| D013514 | Surgical Procedures, Operative |
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| ballon cryoablation | Procedure | ablative treatment as allocated to ballon cryoablation |
|
Time from withdrawal of propofole till patient awake and fully oriented (time, place, person)
| periprocedural |
| contrast medium dosis | Amount of contrast medium used | periprocedural |
| Propofoldosis | Propofoldosis needed for sedation | periprocedural |
| groin complications | Number of Participants in each randomisation arm with groin complications (hematoma, av fistel, Aneuryma spurium, infection). | up to 3 months after dismission from the hospital |
| Neurological complications | Number of Participants in each randomisation arm with transient ischemic attack, cerebral insult, cerebral haemorrhage | 1 year |
| vascular complications | Number of Participants in each randomisation arm with deep vein thrombosis, peripheral embolism. | 1 year |
| duration of hospital staying [days] | duration of hospital staying: from admission till discharge in days | 1 year |
| D013568 |
| Pathological Conditions, Signs and Symptoms |