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Rotational Angiography in Cryoballoon Ablation

Primary Purpose

Atrial Fibrillation

Status
Active
Phase
Not Applicable
Locations
Croatia
Study Type
Interventional
Intervention
Rotational angiography
Sponsored by
University of Zagreb
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atrial Fibrillation focused on measuring preprocedural imaging, Atrial Fibrillation, Rotational angiography

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • longstanding persistent atrial fibrillation
  • renal failure
  • contrast allergy

Sites / Locations

  • KBC Zagreb

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Rotational angio

No rotational angio

Arm Description

Patients that will undergo 3D rotational angiography before cryoballoon ablation

Patients that will receive no preprocedural imaging before cryoballoon ablation

Outcomes

Primary Outcome Measures

ablation success rates
comparison of freedom from atrial fibrillation after ablation procedure

Secondary Outcome Measures

procedure duration
comparison of time required to finish the ablation procedure
radiation exposure
comparison of radiation exposure measured in fluoroscopy time (minutes) and X ray dosage measured in mGy and mcGy/m2.
contrast expenditure
comparison of contrast expenditure (milliliters of contrast used) between 2 groups
complication rates
comparison of complication rates between 2 groups

Full Information

First Posted
February 24, 2020
Last Updated
May 20, 2022
Sponsor
University of Zagreb
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1. Study Identification

Unique Protocol Identification Number
NCT04293757
Brief Title
Rotational Angiography in Cryoballoon Ablation
Official Title
Preprocedural Imaging by Rotational Angiography in Cryoballoon Ablation for Atrial Fibrillation
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
September 1, 2019 (Actual)
Primary Completion Date
August 1, 2022 (Anticipated)
Study Completion Date
August 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Zagreb

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation
Keywords
preprocedural imaging, Atrial Fibrillation, Rotational angiography

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Rotational angio
Arm Type
Experimental
Arm Description
Patients that will undergo 3D rotational angiography before cryoballoon ablation
Arm Title
No rotational angio
Arm Type
No Intervention
Arm Description
Patients that will receive no preprocedural imaging before cryoballoon ablation
Intervention Type
Procedure
Intervention Name(s)
Rotational angiography
Intervention Description
Preprocedural imaging before ablation
Primary Outcome Measure Information:
Title
ablation success rates
Description
comparison of freedom from atrial fibrillation after ablation procedure
Time Frame
1 year
Secondary Outcome Measure Information:
Title
procedure duration
Description
comparison of time required to finish the ablation procedure
Time Frame
1 year
Title
radiation exposure
Description
comparison of radiation exposure measured in fluoroscopy time (minutes) and X ray dosage measured in mGy and mcGy/m2.
Time Frame
1 year
Title
contrast expenditure
Description
comparison of contrast expenditure (milliliters of contrast used) between 2 groups
Time Frame
1 year
Title
complication rates
Description
comparison of complication rates between 2 groups
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: paroxysmal atrial fibrillation persistent atrial fibrillation scheduled for cryoballoon ablation Exclusion Criteria: longstanding persistent atrial fibrillation renal failure contrast allergy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vedran Velagić, MD, PhD
Organizational Affiliation
Clinical Hospital Centre Zagreb
Official's Role
Principal Investigator
Facility Information:
Facility Name
KBC Zagreb
City
Zagreb
ZIP/Postal Code
10000
Country
Croatia

12. IPD Sharing Statement

Plan to Share IPD
No

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Rotational Angiography in Cryoballoon Ablation

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