Radiofrequency Ablation Versus Balloon Cryoablation in Elderly Patients With Atrial Fibrillation

Vivantes Netzwerk für Gesundheit GmbH

Status: Unknown

Conditions: Atrial Fibrillation

Treatments: Procedure: radiofrequency ablation; Procedure: ballon cryoablation

Study type: Interventional

Funder types: Other

Identifiers

NCT04337567

RS_RFCR_ELDPA_0120

Details and patient eligibility

About

This study compares the procedural characteristics and effectivity of radiofrequency ablation and cryoablation in patients with atrial fibrillation that are 75 years or older.

Full description

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.

Enrollment: 80 estimated patients

Sex: All

Ages: 75+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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80 participants in 2 patient groups

Patients over 75 years_RF ablation

Active Comparator group

Description:

Patients randomized to receive pulmonary vein isolation by means of radiofrequency ablation.

Treatment:

Procedure: radiofrequency ablation

Patients over 75 years_ballon cryoablation

Active Comparator group

Description:

Patients randomized to receive pulmonary vein isolation by means of ballon cryoablation.

Treatment:

Procedure: ballon cryoablation