Randomized Comparison Between 3 D CT Overlay and Conventional Fluoroscopy to Decrease Contrast and Radiation Exposure During Cryoballoon Ablation for Atrial Fibrillation

NCT ID: NCT06701383

Last Updated: 2024-11-22

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

TERMINATED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-08-31

Study Completion Date

2015-05-31

Brief Summary

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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.

Detailed Description

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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

NONE

Study Groups

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Standard fluorscopy

Cryoablation using a balloon with standard fluoroscopy

Group Type ACTIVE_COMPARATOR

Cryoablation

Intervention Type DEVICE

Pulmonary vein isolation using cryoablation

3D CT overlay

Cryoablation using a balloon with 3D CT overlay

Group Type EXPERIMENTAL

Cryoablation

Intervention Type DEVICE

Pulmonary vein isolation using cryoablation

Interventions

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Cryoablation

Pulmonary vein isolation using cryoablation

Intervention Type DEVICE

Eligibility Criteria

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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)
* Previous PVI ablation (epicardial or endocardial).
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medisch Spectrum Twente

OTHER

Sponsor Role lead

Responsible Party

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B. Oude Velthuis

cardiologist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jurren van Opstal, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Medisch Spectrum Twente

Locations

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Medisch Spectrum Twente

Enschede, Overijssel, Netherlands

Site Status

Countries

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Netherlands

Other Identifiers

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P12-16

Identifier Type: OTHER

Identifier Source: secondary_id

NL39065.044.11

Identifier Type: -

Identifier Source: org_study_id

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