Radiofrequency Ablation Versus Balloon Cryoablation in Elderly Patients With Atrial Fibrillation

Atrial Fibrillation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04337567
• Other study ID #: RS_RFCR_ELDPA_0120
• Status: Recruiting
• Phase: N/A
• Start date: March 1, 2020
• Est. completion date: January 31, 2024

Study information

• Verified date: April 2020
• Source: Vivantes Netzwerk für Gesundheit GmbH
• Contact: Charalampos Kriatselis, MD
• Phone: 0049 30 15140663741
• Email: charalampos.kriatselis[@]vivantes.de
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: January 31, 2024
• Est. primary completion date: January 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 75 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Procedure:
• radiofrequency ablation
ablative treatment as allocated to radiofrequency ablation
• ballon cryoablation
ablative treatment as allocated to ballon cryoablation

Locations

Country	Name	City	State
Germany	Vivantes Klinikum Neukölln	Berlin

Sponsors (1)

Lead Sponsor	Collaborator
Vivantes Netzwerk für Gesundheit GmbH

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	procedural duration	Duration of the whole procedure [min] inclusive preparation (from entrance to the EP lab till exit from the EP lab)	periprocedural
Secondary	time to wake-up after propofol withdrawal	Time from withdrawal of propofole till patient awake and fully oriented (time, place, person)	periprocedural
Secondary	contrast medium dosis	Amount of contrast medium used	periprocedural
Secondary	Propofoldosis	Propofoldosis needed for sedation	periprocedural
Secondary	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
Secondary	Neurological complications	Number of Participants in each randomisation arm with transient ischemic attack, cerebral insult, cerebral haemorrhage	1 year
Secondary	vascular complications	Number of Participants in each randomisation arm with deep vein thrombosis, peripheral embolism.	1 year
Secondary	duration of hospital staying [days]	duration of hospital staying: from admission till discharge in days	1 year