Rotational Angiography in Cryoballoon Ablation

November 20, 2023 updated by: Vedran Velagic, University of Zagreb

Preprocedural Imaging by Rotational Angiography in Cryoballoon Ablation for Atrial Fibrillation

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

128

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Croatia
      • Zagreb, Croatia, 10000
        • KBC Zagreb

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • longstanding persistent atrial fibrillation
  • renal failure
  • contrast allergy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Rotational angio
Patients that will undergo 3D rotational angiography before cryoballoon ablation
Procedure: Rotational angiography
Preprocedural imaging before ablation
No Intervention: No rotational angio
Patients that will receive no preprocedural imaging before cryoballoon ablation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
ablation success rates
Time Frame: 1 year
comparison of freedom from atrial fibrillation after ablation procedure
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
procedure duration
Time Frame: 1 year
comparison of time required to finish the ablation procedure
1 year
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.
1 year
contrast expenditure
Time Frame: 1 year
comparison of contrast expenditure (milliliters of contrast used) between 2 groups
1 year
complication rates
Time Frame: 1 year
comparison of complication rates between 2 groups
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Zagreb

Investigators

  • Principal Investigator: Vedran Velagic, MD, PhD, Clinical Hospital Centre Zagreb

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2019

Primary Completion (Actual)

October 1, 2023

Study Completion (Actual)

October 1, 2023

Study Registration Dates

First Submitted

February 24, 2020

First Submitted That Met QC Criteria

March 1, 2020

First Posted (Actual)

March 3, 2020

Study Record Updates

Last Update Posted (Actual)

November 21, 2023

Last Update Submitted That Met QC Criteria

November 20, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RA001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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