Radiofrequency Ablation Versus Balloon Cryoablation in Elderly Patients With Atrial Fibrillation

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

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

Study Overview

• Status: Recruiting
• Conditions: Atrial Fibrillation
• Intervention / Treatment: Procedure: radiofrequency ablation; Procedure: ballon cryoablation

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 Type: Interventional
• Enrollment (Anticipated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Charalampos Kriatselis, MD; Phone Number: 0049 30 15140663741; Email: charalampos.kriatselis@vivantes.de
• Study Contact Backup: Name: Michael Distler, MD; Phone Number: 0049 30 130 142014; Email: michael.distler@vivantes.de

Study Locations

• Germany
  • Berlin, Germany
    • Recruiting
    • Vivantes Klinikum Neukölln
    • Contact: Charalampos Kriatselis, MD; Phone Number: 0049 30 15140663741; Email: charalampos.kriatselis@vivantes.de
    • Contact: Michael Distler, MD; Phone Number: 0049 30 130 142014; Email: michael.distler@vivantes.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 75 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Vivantes Netzwerk für Gesundheit GmbH
• Investigators: Principal Investigator: Charalampos Kriatselis, MD, Vivantes Clinic Neukölln

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2020
• Primary Completion (Anticipated): January 31, 2022
• Study Completion (Anticipated): January 31, 2024

Study Registration Dates

• First Submitted: March 8, 2020
• First Submitted That Met QC Criteria: April 3, 2020
• First Posted (Actual): April 7, 2020

Study Record Updates

• Last Update Posted (Actual): April 7, 2020
• Last Update Submitted That Met QC Criteria: April 3, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Keywords: radiofrequency ablation; elderly patients; ablative treatment of atrial fibrillation; ballon cryoablation
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation
• Other Study ID Numbers: RS_RFCR_ELDPA_0120

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No