Rotational Angiography in Cryoballoon Ablation

Atrial Fibrillation Clinical Trial

Official title:

Preprocedural Imaging by Rotational Angiography in Cryoballoon Ablation for Atrial Fibrillation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04293757
• Other study ID #: RA001
• Status: Completed
• Phase: N/A
• Start date: September 1, 2019
• Est. completion date: October 1, 2023

Study information

• Verified date: November 2023
• Source: University of Zagreb
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 128
• Est. completion date: October 1, 2023
• Est. primary completion date: October 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• paroxysmal atrial fibrillation

• persistent atrial fibrillation

• scheduled for cryoballoon ablation

Exclusion Criteria:

• longstanding persistent atrial fibrillation

• renal failure

• contrast allergy

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Procedure:
• Rotational angiography
Preprocedural imaging before ablation

Locations

Country	Name	City	State
Croatia	KBC Zagreb	Zagreb

Sponsors (1)

Lead Sponsor	Collaborator
University of Zagreb

Country where clinical trial is conducted

Croatia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ablation success rates	comparison of freedom from atrial fibrillation after ablation procedure	1 year
Secondary	procedure duration	comparison of time required to finish the ablation procedure	1 year
Secondary	radiation exposure	comparison of radiation exposure measured in fluoroscopy time (minutes) and X ray dosage measured in mGy and mcGy/m2.	1 year
Secondary	contrast expenditure	comparison of contrast expenditure (milliliters of contrast used) between 2 groups	1 year
Secondary	complication rates	comparison of complication rates between 2 groups	1 year