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Completed

NCT Number: NCT04293757

Rotational Angiography in Cryoballoon Ablation

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.

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Key information

Conditions

Atrial Fibrillation Arrhythmias, Cardiac Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

KBC Zagreb

Zagreb, 10000, Croatia

About this study

Around 50% of cardiac electrophysiology (EP) centers are using some kind of imaging to define left atrium and pulmonary vein anatomy before the pulmonary vein isolation (PVI) procedure. Most commonly, CT or MR are performed few days/weeks before the procedure. Three dimensional rotational angiography is least commonly used. However it has the advantage that it can be performed in the EP room just before the ablation procedure. There is still no consensus if any kind of imaging is really needed to perform safe and effective PVI.

The investigators want to determine if 3D rotational angiography (as a mode of preprocedural imaging) has positive impact on procedure safety and efficacy. Also the investigators want to compare the immediate procedure characteristics. The investigators are conducting a randomized study with 1:1 randomization and planning to enroll around 100 participants with 1 year follow up.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • longstanding persistent atrial fibrillation
  • renal failure
  • contrast allergy

Treatment and study plan

Rotational angiography

Procedure

Preprocedural imaging before ablation

Primary outcomes

  1. ablation success rates

    Time frame: 1 year

    comparison of freedom from atrial fibrillation after ablation procedure

Secondary outcomes

  1. procedure duration

    Time frame: 1 year

    comparison of time required to finish the ablation procedure

  2. radiation exposure

    Time frame: 1 year

    comparison of radiation exposure measured in fluoroscopy time (minutes) and X ray dosage measured in mGy and mcGy/m2.

  3. contrast expenditure

    Time frame: 1 year

    comparison of contrast expenditure (milliliters of contrast used) between 2 groups

  4. complication rates

    Time frame: 1 year

    comparison of complication rates between 2 groups

Sponsors and collaborators

Lead sponsor

University of Zagreb

Other

Registry information

Official study title

Preprocedural Imaging by Rotational Angiography in Cryoballoon Ablation for Atrial Fibrillation

Important dates

Study start
2019
Primary completion
2023
Study completion
2023
First posted
Mar 3, 2020
Registry last updated
Nov 21, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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