NCT04293757

Brief Summary

There is still unresolved question weather preprocedural imaging of left atrium and pulmonary veins is needed before the pulmonary vein isolation procedure for the treatment of atrial fibrillation. The investigators are conducting a randomized study to determine if 3D rotational angiography (as a mode of preprocedural imaging) performed before the cryoballoon ablation, facilitates the procedure and has positive impact on procedure characteristics and outcomes.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
128

participants targeted

Target at P50-P75 for not_applicable atrial-fibrillation

Timeline
Completed

Started Sep 2019

Typical duration for not_applicable atrial-fibrillation

Geographic Reach
1 country

1 active site

Status
completed

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

September 1, 2019

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

February 24, 2020

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 3, 2020

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2023

Completed
Last Updated

November 21, 2023

Status Verified

November 1, 2023

Enrollment Period

4.1 years

First QC Date

February 24, 2020

Last Update Submit

November 20, 2023

Conditions

Atrial Fibrillation

Keywords

preprocedural imagingAtrial FibrillationRotational angiography

Outcome Measures

Primary Outcomes (1)

  • ablation success rates

    comparison of freedom from atrial fibrillation after ablation procedure

    1 year

Secondary Outcomes (4)

  • procedure duration

    1 year

  • radiation exposure

    1 year

  • contrast expenditure

    1 year

  • complication rates

    1 year

Study Arms (2)

Rotational angio

EXPERIMENTAL

Patients that will undergo 3D rotational angiography before cryoballoon ablation

Procedure: Rotational angiography

No rotational angio

NO INTERVENTION

Patients that will receive no preprocedural imaging before cryoballoon ablation

Interventions

Rotational angiographyPROCEDURE

Preprocedural imaging before ablation

Rotational angio

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • paroxysmal atrial fibrillation
  • persistent atrial fibrillation
  • scheduled for cryoballoon ablation

You may not qualify if:

  • longstanding persistent atrial fibrillation
  • renal failure
  • contrast allergy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

KBC Zagreb

Zagreb, 10000, Croatia

Location

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Vedran Velagić, MD, PhD

    Clinical Hospital Centre Zagreb

    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
Assistant professor, MD, PhD

Study Record Dates

First Submitted

February 24, 2020

First Posted

March 3, 2020

Study Start

September 1, 2019

Primary Completion

October 1, 2023

Study Completion

October 1, 2023

Last Updated

November 21, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

Locations

CR(1)