Radiofrequency Ablation Versus Balloon Cryoablation in Elderly Patients With Atrial Fibrillation

Vivantes Netzwerk für Gesundheit GmbH80 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Atrial Fibrillation

Interventions

radiofrequency ablationPROCEDURE

ablative treatment as allocated to radiofrequency ablation

ballon cryoablationPROCEDURE

ablative treatment as allocated to ballon cryoablation

Eligibility

Sex: ALLMin age: 75 Years

Medical Language ↔ Plain English

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.

Locations (1)

Vivantes Klinikum Neukölln

Berlin, Germany

RECRUITING

Outcomes

Primary Outcomes

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

Time frame: 1 year

Secondary Outcomes

procedural duration

Duration of the whole procedure \[min\] inclusive preparation (from entrance to the EP lab till exit from the EP lab)

Time frame: periprocedural

time to wake-up after propofol withdrawal

Time from withdrawal of propofole till patient awake and fully oriented (time, place, person)

Time frame: periprocedural

contrast medium dosis

Amount of contrast medium used

Time frame: periprocedural

Propofoldosis

Propofoldosis needed for sedation

Time frame: periprocedural

groin complications

Number of Participants in each randomisation arm with groin complications (hematoma, av fistel, Aneuryma spurium, infection).

Time frame: 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

Time frame: 1 year

vascular complications

Number of Participants in each randomisation arm with deep vein thrombosis, peripheral embolism.

Central Contacts

Charalampos Kriatselis, MD

CONTACT

0049 30 15140663741 charalampos.kriatselis@vivantes.de

Michael Distler, MD

CONTACT

0049 30 130 142014 michael.distler@vivantes.de

Data from ClinicalTrials.gov

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