Radiofrequency Ablation Versus Balloon Cryoablation in Elderly Patients With Atrial Fibrillation

Sponsor

Vivantes Netzwerk für Gesundheit GmbH (Other)

Overall Status

Recruiting

CT.gov ID

NCT04337567

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

1.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Atrial Fibrillation	Procedure: radiofrequency ablation Procedure: ballon cryoablation	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

80 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Mar 1, 2020

Anticipated Primary Completion Date :

Jan 31, 2022

Anticipated Study Completion Date :

Jan 31, 2024

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

75 Years and Older

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Vivantes Klinikum Neukölln	Berlin		Germany

Sponsors and Collaborators

Vivantes Netzwerk für Gesundheit GmbH

Investigators

Principal Investigator: Charalampos Kriatselis, MD, Vivantes Klinikum Neukölln

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Charalampos Kriatselis, Principal Investigator, Vivantes Netzwerk für Gesundheit GmbH

ClinicalTrials.gov Identifier:

NCT04337567

Other Study ID Numbers:

RS_RFCR_ELDPA_0120

First Posted:

Apr 7, 2020

Last Update Posted:

Apr 7, 2020

Last Verified:

Apr 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Charalampos Kriatselis, Principal Investigator, Vivantes Netzwerk für Gesundheit GmbH

ablative treatment of atrial fibrillation

ballon cryoablation

radiofrequency ablation

elderly patients

Additional relevant MeSH terms:

Atrial Fibrillation

Study Results

No Results Posted as of Apr 7, 2020