NCT04337567

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P25-P50 for not_applicable atrial-fibrillation

Timeline
Completed

Started Mar 2020

Typical duration for not_applicable atrial-fibrillation

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2020

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

March 8, 2020

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 7, 2020

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2022

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2024

Completed
Last Updated

April 7, 2020

Status Verified

April 1, 2020

Enrollment Period

1.9 years

First QC Date

March 8, 2020

Last Update Submit

April 3, 2020

Conditions

Atrial Fibrillation

Keywords

ablative treatment of atrial fibrillationballon cryoablationradiofrequency ablationelderly patients

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (8)

  • procedural duration

    periprocedural

  • time to wake-up after propofol withdrawal

    periprocedural

  • contrast medium dosis

    periprocedural

  • Propofoldosis

    periprocedural

  • groin complications

    up to 3 months after dismission from the hospital

  • +3 more secondary outcomes

Study Arms (2)

Patients over 75 years_RF ablation

ACTIVE COMPARATOR

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

Procedure: radiofrequency ablation

Patients over 75 years_ballon cryoablation

ACTIVE COMPARATOR

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

Procedure: ballon cryoablation

Interventions

radiofrequency ablationPROCEDURE

ablative treatment as allocated to radiofrequency ablation

Patients over 75 years_RF ablation
ballon cryoablationPROCEDURE

ablative treatment as allocated to ballon cryoablation

Patients over 75 years_ballon cryoablation

Eligibility Criteria

Age75 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • Patients with recurrent symptomatic paroxysmal or persistent atrial fibrillation

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vivantes Klinikum Neukölln

Berlin, Germany

RECRUITING

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Radiofrequency Ablation

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Radiofrequency TherapyTherapeuticsAblation TechniquesSurgical Procedures, Operative

Study Officials

  • Charalampos Kriatselis, MD

    Vivantes Clinic Neukölln

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Charalampos Kriatselis, MD

CONTACT

0049 30 15140663741charalampos.kriatselis@vivantes.de

Michael Distler, MD

CONTACT

0049 30 130 142014michael.distler@vivantes.de

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 8, 2020

First Posted

April 7, 2020

Study Start

March 1, 2020

Primary Completion

January 31, 2022

Study Completion

January 31, 2024

Last Updated

April 7, 2020

Record last verified: 2020-04

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)