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

Atrial Fibrillation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03786822
• Other study ID #: STU 042013-074
• Status: Completed
• Phase: N/A
• Start date: June 1, 2015
• Est. completion date: December 20, 2016

Study information

• Verified date: December 2018
• Source: University of Texas Southwestern Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1
• Est. completion date: December 20, 2016
• Est. primary completion date: December 20, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Procedure:
• 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.

Locations

Country	Name	City	State
United States	University of Texas Southwestern	Dallas	Texas

Sponsors (2)

Lead Sponsor	Collaborator
University of Texas Southwestern Medical Center	Medtronic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction of Radiation Dose during Cryoballoon Pulmonary Vein Isolation.	change in the composite endpoint of total fluoroscopy time (min)	one year
Primary	Reduction of Contrast during Cryoballoon Pulmonary Vein Isolation.	change in the composite endpoint of contrast (cc)	one year
Secondary	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)	one year
Secondary	Time to Cryoballoon Pulmonary Vein Isolation	•cryoballoon procedure time (min)	one year