Radiofrequency Ablation Versus Balloon Cryoablation in Elderly Patients With Atrial Fibrillation

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Prospective Randomized Trial for the Comparison of Procedural Characteristics and Long-term Effects of Radiofrequency Ablation and Balloon Cryoablation in Elderly Patients With Atrial Fibrillation

Conditions
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Atrial Fibrillation

Intervention / Treatment
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* Procedure: radiofrequency ablation
* Procedure: ballon cryoablation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with recurrent symptomatic paroxysmal or persistent atrial fibrillation At the day of their inclusion in the study the patients have to have completed the 75th year of life Exclusion Criteria: Dementia Presence of left atrial thrombus Left atrial volume> 50 ml/m² Renal failure (GFR≤ 30 ml/min) Comorbidity with an expected survival of 12 months or less.

Ages Eligible for Study
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Minimum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Patients over 75 years_RF ablation<br>Patients randomized to receive pulmonary vein isolation by means of radiofrequency ablation. | Procedure: radiofrequency ablation<br>* ablative treatment as allocated to radiofrequency ablation<br>|
| Active Comparator: Patients over 75 years_ballon cryoablation<br>Patients randomized to receive pulmonary vein isolation by means of ballon cryoablation. | Procedure: ballon cryoablation<br>* ablative treatment as allocated to ballon cryoablation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ablative treatment of atrial fibrillation, ballon cryoablation, radiofrequency ablation, elderly patients