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

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.

Study Overview

• Status: Completed
• Conditions: Atrial Fibrillation
• Intervention / Treatment: Procedure: Cryoballoon Pulmonary Vein Isolation - PVI

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.

• Study Type: Interventional
• Enrollment (Actual): 1
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Dallas, Texas, United States, 75390
      • University of Texas Southwestern

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Non-fluoroscopic Cryoballoon PVI; 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.	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.; Other Names: Atrial Fibrillation Ablation
Active Comparator: Fluoroscopic Cryoballoon PVI; Standard cryoballoon PVI using radio opaque contrast pulmonary vein angiography	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.; Other Names: Atrial Fibrillation Ablation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reduction of Radiation Dose during Cryoballoon Pulmonary Vein Isolation.	change in the composite endpoint of total fluoroscopy time (min)	one year
Reduction of Contrast during Cryoballoon Pulmonary Vein Isolation.	change in the composite endpoint of contrast (cc)	one year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Time to Cryoballoon Pulmonary Vein Isolation	•cryoballoon procedure time (min)	one year

Collaborators and Investigators

• Sponsor: University of Texas Southwestern Medical Center
• Collaborators: Medtronic

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2015
• Primary Completion (Actual): December 20, 2016
• Study Completion (Actual): December 20, 2016

Study Registration Dates

• First Submitted: November 29, 2018
• First Submitted That Met QC Criteria: December 20, 2018
• First Posted (Actual): December 26, 2018

Study Record Updates

• Last Update Posted (Actual): December 26, 2018
• Last Update Submitted That Met QC Criteria: December 20, 2018
• Last Verified: December 1, 2018

More Information

Terms related to this study

• Keywords: Atrial fibrillation; cryoballoon; pulmonary vein isolation
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation
• Other Study ID Numbers: STU 042013-074