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Reduction of Radiation Dose and Contrast Use During Cryoballoon Pulmonary Vein Isolation

Primary Purpose

Atrial Fibrillation

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Cryoballoon Pulmonary Vein Isolation - PVI

About this trial

This is an interventional treatment trial for Atrial Fibrillation focused on measuring cryoballoon, Atrial fibrillation, pulmonary vein isolation

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Paroxysmal atrial fibrillation refractory to treatment with anti-arrhythmic drugs
Must be able to undergo pre-operative cardiac CT angiogram or cardiac MRI to define pulmonary vein anatomy.

Exclusion criteria:

Planned use of radiofrequency cardiac ablation
Presence of a cardiac implantable electronic device
Conditions where manipulation of the catheter would be unsafe such as intracardiac thrombus
Patients with active systemic infections
Patients with cryoglobulinemia
Pregnant and/or breast-feeding females are excluded from this study.

Sites / Locations

University of Texas Southwestern

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Non-fluoroscopic Cryoballoon PVI

Fluoroscopic Cryoballoon PVI

Arm Description

Observation of pressure waveform change at the tip of the cryoballoon catheter from left atrial pressure to pulmonary vein pressure waveform. Intracardiac echocardiography (ICE) imaging with no Doppler color evidence of peri-balloon high velocity leaks. Intracardiac echo imaging showing no evidence of leak during agitated saline contrast injection into cryoballoon catheter positioned at pulmonary vein ostium.

Standard cryoballoon PVI using radio opaque contrast pulmonary vein angiography

Outcomes

Primary Outcome Measures

Reduction of Radiation Dose during Cryoballoon Pulmonary Vein Isolation.

change in the composite endpoint of total fluoroscopy time (min)

Reduction of Contrast during Cryoballoon Pulmonary Vein Isolation.

change in the composite endpoint of contrast (cc)

Secondary Outcome Measures

Recurrence of atrial fibrillation

•recurrence of atrial fibrillation after 1 month blanking period measured by ECG event monitoring at 6 and 12 month follow up (time to first recurrence in months, total number of episodes, and total duration in hours)

Time to Cryoballoon Pulmonary Vein Isolation

•cryoballoon procedure time (min)

Full Information

NCT ID

NCT03786822

First Posted

November 29, 2018

Last Updated

December 20, 2018

Sponsor

University of Texas Southwestern Medical Center

Collaborators

Medtronic

1. Study Identification

Unique Protocol Identification Number

NCT03786822

Brief Title

Reduction of Radiation Dose and Contrast Use During Cryoballoon Pulmonary Vein Isolation

Official Title

Reduction of Radiation Dose and Contrast Use During Cryoballoon Pulmonary Vein Isolation

Study Type

Interventional

2. Study Status

Record Verification Date

December 2018

Overall Recruitment Status

Completed

Study Start Date

June 1, 2015 (Actual)

Primary Completion Date

December 20, 2016 (Actual)

Study Completion Date

December 20, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Texas Southwestern Medical Center

Collaborators

Medtronic

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

This is a multi-site, randomized, investigator-initiated pilot study to evaluate the efficacy of investigational techniques to reduce fluoroscopy time or radiation dose and the amount of radio opaque contrast used during a cryoballoon pulmonary vein isolation procedure for atrial fibrillation. One group of subjects will have the procedure performed with intracardiac echo maneuvers to assess cryoballoon occlusion of the pulmonary vein and will be compared to a group of subjects who will receive the standard medical treatment with fluoroscopy and angiography.

Detailed Description

Surgical and catheter based technologies target triggers that initiate atrial fibrillation located in the pulmonary veins (PV). In order to isolate these triggers, radiofrequency energy or freezing is used to destroy the atrial tissue which propagate electrical impulses into and out of the pulmonary veins (PV), to achieve pulmonary vein isolation (PVI). Use of a patented cryoballoon catheter (Medtronic) to perform PVI has been shown to be safe and efficacious under fluoroscopic guidance with contrast angiography. The objective of this study is to identify methods to reduce radiation dose and radio opaque contrast use while maintaining PVI efficacy and safety.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Atrial Fibrillation

Keywords

cryoballoon, Atrial fibrillation, pulmonary vein isolation

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

Condition or Disease: Paroxysmal atrial fibrillation Procedure: Cryoballoon Pulmonary Vein Isolation

Masking

Outcomes Assessor

Masking Description

Subjects will be randomized in a 2:1 fashion

Allocation

Randomized

Enrollment

1 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Non-fluoroscopic Cryoballoon PVI

Arm Type

Experimental

Arm Description

Arm Title

Fluoroscopic Cryoballoon PVI

Arm Type

Active Comparator

Arm Description

Standard cryoballoon PVI using radio opaque contrast pulmonary vein angiography

Intervention Type

Procedure

Intervention Name(s)

Cryoballoon Pulmonary Vein Isolation - PVI

Other Intervention Name(s)

Atrial Fibrillation Ablation

Intervention Description

A 28-mm cryoballoon (Arctic Front Advance™ Cardiac CryoAblation Catheter, Medtronic, Minneapolis, MN) will be employed. The cryoballoon catheter will be introduced into the left atrium, following a single transeptal puncture, through a 12 French steerable sheath (FlexCath, Medtronic), constantly flushed with heparinized saline. A circular mapping catheter (Achieve, Medtronic) will be advanced through the cryoballoon to the PV orifice and positioned as proximally as possible inside the vessel to record the PV potentials at baseline and monitor the isolation procedure in real time.

Primary Outcome Measure Information:

Title

Reduction of Radiation Dose during Cryoballoon Pulmonary Vein Isolation.

Description

change in the composite endpoint of total fluoroscopy time (min)

Time Frame

one year

Title

Reduction of Contrast during Cryoballoon Pulmonary Vein Isolation.

Description

change in the composite endpoint of contrast (cc)

Time Frame

one year

Secondary Outcome Measure Information:

Title

Recurrence of atrial fibrillation

Description

Time Frame

one year

Title

Time to Cryoballoon Pulmonary Vein Isolation

Description

•cryoballoon procedure time (min)

Time Frame

one year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Paroxysmal atrial fibrillation refractory to treatment with anti-arrhythmic drugs Must be able to undergo pre-operative cardiac CT angiogram or cardiac MRI to define pulmonary vein anatomy. Exclusion criteria: Planned use of radiofrequency cardiac ablation Presence of a cardiac implantable electronic device Conditions where manipulation of the catheter would be unsafe such as intracardiac thrombus Patients with active systemic infections Patients with cryoglobulinemia Pregnant and/or breast-feeding females are excluded from this study.

Facility Information:

Facility Name

University of Texas Southwestern

City

Dallas

State/Province

Texas

ZIP/Postal Code

75390

Country

United States

12. IPD Sharing Statement

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Reduction of Radiation Dose and Contrast Use During Cryoballoon Pulmonary Vein Isolation

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