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

NCT ID: NCT03786822

Last Updated: 2018-12-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 1 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-06-01
• Study Completion Date: 2016-12-20

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.

Conditions

Atrial Fibrillation

Keywords

cryoballoon; Atrial fibrillation; pulmonary vein isolation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Non-fluoroscopic Cryoballoon PVI

1. Observation of pressure waveform change at the tip of the cryoballoon catheter from left atrial pressure to pulmonary vein pressure waveform.

2. Intracardiac echocardiography (ICE) imaging with no Doppler color evidence of peri-balloon high velocity leaks.

3. Intracardiac echo imaging showing no evidence of leak during agitated saline contrast injection into cryoballoon catheter positioned at pulmonary vein ostium.

Group Type: EXPERIMENTAL

Cryoballoon Pulmonary Vein Isolation - PVI

Intervention Type: PROCEDURE

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.

Fluoroscopic Cryoballoon PVI

Standard cryoballoon PVI using radio opaque contrast pulmonary vein angiography

Group Type: ACTIVE_COMPARATOR

Cryoballoon Pulmonary Vein Isolation - PVI

Intervention Type: PROCEDURE

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.

Interventions

Cryoballoon Pulmonary Vein Isolation - PVI

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.

Intervention Type: PROCEDURE

Other Intervention Names

Atrial Fibrillation Ablation

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medtronic

INDUSTRY

Sponsor Role: collaborator

University of Texas Southwestern Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Richard Wu

Professor of Internal Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University of Texas Southwestern

Dallas, Texas, United States

Countries

United States

Other Identifiers

STU 042013-074

Identifier Type: -

Identifier Source: org_study_id