Radiofrequency Ablation Versus Balloon Cryoablation in Elderly Patients With Atrial Fibrillation

NCT ID: NCT04337567

Last Updated: 2020-04-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-03-01

Study Completion Date

2024-01-31

Brief Summary

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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

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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.

Conditions

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Atrial Fibrillation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Patients over 75 years_RF ablation

Patients randomized to receive pulmonary vein isolation by means of radiofrequency ablation.

Group Type ACTIVE_COMPARATOR

radiofrequency ablation

Intervention Type PROCEDURE

ablative treatment as allocated to radiofrequency ablation

Patients over 75 years_ballon cryoablation

Patients randomized to receive pulmonary vein isolation by means of ballon cryoablation.

Group Type ACTIVE_COMPARATOR

ballon cryoablation

Intervention Type PROCEDURE

ablative treatment as allocated to ballon cryoablation

Interventions

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radiofrequency ablation

ablative treatment as allocated to radiofrequency ablation

Intervention Type PROCEDURE

ballon cryoablation

ablative treatment as allocated to ballon cryoablation

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Vivantes Netzwerk für Gesundheit GmbH

OTHER

Sponsor Role lead

Responsible Party

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Charalampos Kriatselis

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Charalampos Kriatselis, MD

Role: PRINCIPAL_INVESTIGATOR

Vivantes Clinic Neukölln

Locations

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Vivantes Klinikum Neukölln

Berlin, , Germany

Site Status RECRUITING

Countries

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Germany

Central Contacts

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Charalampos Kriatselis, MD

Role: CONTACT

0049 30 15140663741

Michael Distler, MD

Role: CONTACT

0049 30 130 142014

Facility Contacts

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Charalampos Kriatselis, MD

Role: primary

0049 30 15140663741

Michael Distler, MD

Role: backup

0049 30 130 142014

Other Identifiers

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RS_RFCR_ELDPA_0120

Identifier Type: -

Identifier Source: org_study_id

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