Research with human participants

Overview of medical research in the Netherlands

A randomized comparison between 3 D CT overlay and conventional fluoroscopy to decrease contrast and radiation exposure during cryoballoon ablation for atrial fibrillation

Published:
Last updated:

This study will provide data on fluoroscopy exposure, use of contrast agents and effectiveness of the combined use of cryoballoon ablation and 3D CT overlay

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Ethical review
Approved WMO
Status
Recruitment stopped
Health condition type
Other condition
Study type
Interventional

ID

NL-OMON37693

Source

ToetsingOnline

Brief title

CAFE

Condition

  • Other condition
  • Cardiac arrhythmias

Synonym

atrial fibrillation

Health condition

minimaal invasieve interventie

Research involving

Human

Sponsors and support

Primary sponsor :
Medisch Spectrum Twente
Source(s) of monetary or material Support :
Stichting Hartcentrum Twente

Intervention

Keyword :
3 D CT overlay, Ablation, Atrial fibrillation, pulmonary vein isolation

Outcome measures

Primary outcome

To compare the fluoroscopy time, radiation exposure (DAP) and amount of

contrast medium between cryoballoon ablation with and without the use of 3D CT

overlay

Secondary outcome

The percentage of patients without a recurrence of AF, without AADs, within a

follow-up period of at least 12 months after a stabilisation period of 90 days

after the initial procedure.

Background summary

Cryoablation using a balloon is an effective therapy for paroxysmal atrial
fibrillation (AF), however associated with significant amounts of radiation
exposure and contrast medium use. A new imaging technique (3D CT overlay) could
reduce radiation exposure and contrast medium use significantly.

Study objective

This study will provide data on fluoroscopy exposure, use of contrast agents
and effectiveness of the combined use of cryoballoon ablation and 3D CT
overlay

Study design

The study is designed as a prospective single centre randomized study, with a
follow-up of 1 year

Intervention

Cryoablation using a balloon with standard fluoroscopy versus cryoablation with
3D CT overlay

Study burden and risks

No additional risk is present for participants in the study.

Public
Medisch Spectrum Twente

Haaksbergerstraat 55
Enschede 7513 ER
NL
Scientific
Medisch Spectrum Twente

Haaksbergerstraat 55
Enschede 7513 ER
NL

Listed location countries

Netherlands

Age

Adults (18-64 years)
Elderly (65 years and older)

Inclusion criteria

All patients screened are accepted for PVI according to the current guidelines. Patients are candidates for enrolment if they have paroxysmal AF as defined in the guidelines

Exclusion criteria

Persistent, long-standing persistent or permanent AF, left atrial diameter > 50 mm (measured in the parasternal long axis, as assessed with transthoracic echocardiography)and previous PVI ablation (epicardial or endocardial).

Design

Study type :
Interventional
Intervention model
:
Parallel
Allocation :
Randomized controlled trial
Masking :
Single blinded (masking used)
Control :
Active
Primary purpose :
Treatment

Recruitment

NL
Recruitment status
:
Recruitment stopped
Start date (anticipated) :
Enrollment :
94
Type :
Actual

Medical products/devices used

Generic name :
3 D CT overlay
Registration
:
Yes - CE intended use

Approved WMO
Date :
Application type :
First submission
Review commission :
METC Twente (Enschede)

Followed up by the following (possibly more current) registration

No registrations found.

Other (possibly less up-to-date) registrations in this register

No registrations found.

In other registers

Register ID
Other clincialtrials.gov Record NL39065.044.11
CCMO NL39065.044.11