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

• Sponsor: University of Texas Southwestern Medical Center (Other)
• Overall Status: Completed
• CT.gov ID: NCT03786822
• Collaborator: Medtronic (Industry)
• Enrollment: 1
• Location: 1
• Arms: 2
• Actual Duration (Months): 18.7
• Patients Per Site Per Month: 0.1

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Atrial Fibrillation	Procedure: Cryoballoon Pulmonary Vein Isolation - PVI	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 1 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Condition or Disease: Paroxysmal atrial fibrillation Procedure: Cryoballoon Pulmonary Vein IsolationCondition or Disease: Paroxysmal atrial fibrillation Procedure: Cryoballoon Pulmonary Vein Isolation
• Masking: Single (Outcomes Assessor)
• Masking Description: Subjects will be randomized in a 2:1 fashion
• Primary Purpose: Treatment
• Official Title: Reduction of Radiation Dose and Contrast Use During Cryoballoon Pulmonary Vein Isolation
• Actual Study Start Date: Jun 1, 2015
• Actual Primary Completion Date: Dec 20, 2016
• Actual Study Completion Date: Dec 20, 2016

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Reduction of Radiation Dose during Cryoballoon Pulmonary Vein Isolation. [one year]

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

2. Reduction of Contrast during Cryoballoon Pulmonary Vein Isolation. [one year]

   change in the composite endpoint of contrast (cc)

Secondary Outcome Measures

1. Recurrence of atrial fibrillation [one year]

   •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)

2. Time to Cryoballoon Pulmonary Vein Isolation [one year]

   •cryoballoon procedure time (min)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Texas Southwestern	Dallas	Texas	United States	75390

Sponsors and Collaborators

• University of Texas Southwestern Medical Center
• Medtronic

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Richard Wu, Professor of Internal Medicine, University of Texas Southwestern Medical Center
• ClinicalTrials.gov Identifier: NCT03786822
• Other Study ID Numbers: STU 042013-074
• First Posted: Dec 26, 2018
• Last Update Posted: Dec 26, 2018
• Last Verified: Dec 1, 2018

• Keywords provided by Richard Wu, Professor of Internal Medicine, University of Texas Southwestern Medical Center: cryoballoon; Atrial fibrillation; pulmonary vein isolation
• Additional relevant MeSH terms: Atrial Fibrillation

Study Results

No Results Posted as of Dec 26, 2018