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

NCT03786822 | Completed

• 1 other identifier: STU 042013-074
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

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.

Conditions

Atrial Fibrillation

Keywords

cryoballoon; Atrial fibrillation; pulmonary vein isolation

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Recurrence of atrial fibrillation

  one year

• Time to Cryoballoon Pulmonary Vein Isolation

  one year

Study Arms (2)

Non-fluoroscopic Cryoballoon PVI

EXPERIMENTAL

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.

Procedure: Cryoballoon Pulmonary Vein Isolation - PVI

Fluoroscopic Cryoballoon PVI

ACTIVE COMPARATOR

Standard cryoballoon PVI using radio opaque contrast pulmonary vein angiography

Procedure: Cryoballoon Pulmonary Vein Isolation - PVI

Interventions

Cryoballoon Pulmonary Vein Isolation - PVI 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.

Also known as: Atrial Fibrillation Ablation

Fluoroscopic Cryoballoon PVI; Non-fluoroscopic Cryoballoon PVI

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead
• Medtronic: collaborator

Study Sites (1)

University of Texas Southwestern

Dallas, Texas, 75390, United States

Location

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Subjects will be randomized in a 2:1 fashion
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Internal Medicine

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

Study Record Dates

• First Submitted: November 29, 2018
• First Posted: December 26, 2018
• Study Start: June 1, 2015
• Primary Completion: December 20, 2016
• Study Completion: December 20, 2016
• Last Updated: December 26, 2018

Record last verified: 2018-12

Locations

US (1)