Radiofrequency Ablation Versus Balloon Cryoablation in Elderly Patients With Atrial Fibrillation

Not Applicable

• Conditions: Atrial Fibrillation
• Interventions: Procedure: ballon cryoablation; Procedure: radiofrequency ablation

• Registration Number: NCT04337567
• Lead Sponsor: Vivantes Netzwerk für Gesundheit GmbH

Brief Summary

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

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.

Study Timeline

• Study Start: 2020-03-01
• Study First Submitted: 2020-03-08
• Status Verified: 2020-04
• Study First Submitted QC: 2020-04-03
• Last Update Submitted: 2020-04-03
• Study First Posted: 2020-04-07
• Last Update Posted: 2020-04-07
• Primary Completion: 2022-01-31
• Study Completion: 2024-01-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 80

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Patients over 75 years_ballon cryoablation	ballon cryoablation	Patients randomized to receive pulmonary vein isolation by means of ballon cryoablation.
Patients over 75 years_RF ablation	radiofrequency ablation	Patients randomized to receive pulmonary vein isolation by means of radiofrequency ablation.

Primary Outcome Measures

Name	Time	Method
atrial arrhythmia recurrence	1 year	Number of Participants with recurrence of any atrial arrhythmia with a duration of 30 sec or longer 12 months after the ablative treatment

Secondary Outcome Measures

Name	Time	Method
procedural duration	periprocedural	Duration of the whole procedure \[min\] inclusive preparation (from entrance to the EP lab till exit from the EP lab)
contrast medium dosis	periprocedural	Amount of contrast medium used
Propofoldosis	periprocedural	Propofoldosis needed for sedation
vascular complications	1 year	Number of Participants in each randomisation arm with deep vein thrombosis, peripheral embolism.
groin complications	up to 3 months after dismission from the hospital	Number of Participants in each randomisation arm with groin complications (hematoma, av fistel, Aneuryma spurium, infection).
time to wake-up after propofol withdrawal	periprocedural	Time from withdrawal of propofole till patient awake and fully oriented (time, place, person)
Neurological complications	1 year	Number of Participants in each randomisation arm with transient ischemic attack, cerebral insult, cerebral haemorrhage
duration of hospital staying [days]	1 year	duration of hospital staying: from admission till discharge in days

Trial Locations

Locations (1)

Vivantes Klinikum Neukölln; 🇩🇪 Berlin, Germany