NCT06701383

Brief 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.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable atrial-fibrillation

Timeline
Completed

Started Aug 2012

Geographic Reach
1 country

1 active site

Status
terminated

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

August 1, 2012

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2014

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2015

Completed
9.6 years until next milestone

First Submitted

Initial submission to the registry

November 20, 2024

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 22, 2024

Completed
Last Updated

November 22, 2024

Status Verified

November 1, 2024

Enrollment Period

1.7 years

First QC Date

November 20, 2024

Last Update Submit

November 20, 2024

Conditions

Atrial Fibrillation

Outcome Measures

Primary Outcomes (3)

  • Fluoroscopy time

    To compare the fluoroscopy time between cryoballoon ablation with and without the use of 3D CT overlay

    Procedure time

  • radiation exposure

    To compare the radiation exposure (DAP) between cryoballoon ablation with and without the use of 3D CT overlay

    Procedure time

  • Contrast

    To compare the amount of contrast medium between cryoballoon ablation with and without the use of 3D CT overlay

    Amount of contrast during procedure

Secondary Outcomes (1)

  • Recurrence

    one year

Study Arms (2)

Standard fluorscopy

ACTIVE COMPARATOR

Cryoablation using a balloon with standard fluoroscopy

Device: Cryoablation

3D CT overlay

EXPERIMENTAL

Cryoablation using a balloon with 3D CT overlay

Device: Cryoablation

Interventions

CryoablationDEVICE

Pulmonary vein isolation using cryoablation

3D CT overlayStandard fluorscopy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \- 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

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medisch Spectrum Twente

Enschede, Overijssel, 7500, Netherlands

Location

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Cryosurgery

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ablation TechniquesSurgical Procedures, Operative

Study Officials

  • Jurren van Opstal, MD, PhD

    Medisch Spectrum Twente

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
cardiologist

Study Record Dates

First Submitted

November 20, 2024

First Posted

November 22, 2024

Study Start

August 1, 2012

Primary Completion

May 1, 2014

Study Completion

May 1, 2015

Last Updated

November 22, 2024

Record last verified: 2024-11

Locations

NL(1)