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Radiofrequency Ablation Versus Balloon Cryoablation in Elderly Patients With Atrial Fibrillation

Primary Purpose

Atrial Fibrillation

Status

Recruiting

Phase

Not Applicable

Locations

Germany

Study Type

Interventional

Intervention

radiofrequency ablation

ballon cryoablation

About this trial

This is an interventional treatment trial for Atrial Fibrillation focused on measuring ablative treatment of atrial fibrillation, ballon cryoablation, radiofrequency ablation, elderly patients

Eligibility Criteria

75 Years - undefined (Older Adult)All SexesDoes not accept 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.

Sites / Locations

Vivantes Klinikum NeuköllnRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Patients over 75 years_RF ablation

Patients over 75 years_ballon cryoablation

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

procedural duration

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

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

contrast medium dosis

Amount of contrast medium used

Propofoldosis

Propofoldosis needed for sedation

groin complications

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

Neurological complications

Number of Participants in each randomisation arm with transient ischemic attack, cerebral insult, cerebral haemorrhage

vascular complications

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

duration of hospital staying [days]

duration of hospital staying: from admission till discharge in days

Full Information

NCT ID

NCT04337567

First Posted

March 8, 2020

Last Updated

April 3, 2020

Sponsor

Vivantes Netzwerk für Gesundheit GmbH

1. Study Identification

Unique Protocol Identification Number

NCT04337567

Brief Title

Radiofrequency Ablation Versus Balloon Cryoablation in Elderly Patients With Atrial Fibrillation

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2020

Overall Recruitment Status

Recruiting

Study Start Date

March 1, 2020 (Actual)

Primary Completion Date

January 31, 2022 (Anticipated)

Study Completion Date

January 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Vivantes Netzwerk für Gesundheit GmbH

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Atrial Fibrillation

Keywords

ablative treatment of atrial fibrillation, ballon cryoablation, radiofrequency ablation, elderly patients

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Patients over 75 years_RF ablation

Arm Type

Active Comparator

Arm Description

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

Arm Title

Patients over 75 years_ballon cryoablation

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Procedure

Intervention Name(s)

radiofrequency ablation

Intervention Description

ablative treatment as allocated to radiofrequency ablation

Intervention Type

Procedure

Intervention Name(s)

ballon cryoablation

Intervention Description

ablative treatment as allocated to ballon cryoablation

Primary Outcome Measure Information:

Title

atrial arrhythmia recurrence

Description

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 Outcome Measure Information:

Title

procedural duration

Description

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

Time Frame

periprocedural

Title

time to wake-up after propofol withdrawal

Description

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

Time Frame

periprocedural

Title

contrast medium dosis

Description

Amount of contrast medium used

Time Frame

periprocedural

Title

Propofoldosis

Description

Propofoldosis needed for sedation

Time Frame

periprocedural

Title

groin complications

Description

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

Title

Neurological complications

Description

Number of Participants in each randomisation arm with transient ischemic attack, cerebral insult, cerebral haemorrhage

Time Frame

1 year

Title

vascular complications

Description

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

Time Frame

1 year

Title

duration of hospital staying [days]

Description

duration of hospital staying: from admission till discharge in days

Time Frame

1 year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Charalampos Kriatselis, MD

Phone

0049 30 15140663741

charalampos.kriatselis@vivantes.de

First Name & Middle Initial & Last Name or Official Title & Degree

Michael Distler, MD

Phone

0049 30 130 142014

michael.distler@vivantes.de

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Charalampos Kriatselis, MD

Organizational Affiliation

Vivantes Clinic Neukölln

Official's Role

Principal Investigator

Facility Information:

Facility Name

Vivantes Klinikum Neukölln

City

Berlin

Country

Germany

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Charalampos Kriatselis, MD

Phone

0049 30 15140663741

charalampos.kriatselis@vivantes.de

First Name & Middle Initial & Last Name & Degree

Michael Distler, MD

Phone

0049 30 130 142014

michael.distler@vivantes.de

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Radiofrequency Ablation Versus Balloon Cryoablation in Elderly Patients With Atrial Fibrillation

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