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Completed

NCT Number: NCT03786822

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.

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Key information

Conditions

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

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Texas Southwestern

Dallas, Texas, 75390, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Other names: Atrial Fibrillation Ablation

Primary outcomes

  1. Reduction of Radiation Dose during Cryoballoon Pulmonary Vein Isolation.

    Time frame: one year

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

  2. Reduction of Contrast during Cryoballoon Pulmonary Vein Isolation.

    Time frame: one year

    change in the composite endpoint of contrast (cc)

Secondary outcomes

  1. Recurrence of atrial fibrillation

    Time frame: 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

    Time frame: one year

    •cryoballoon procedure time (min)

Sponsors and collaborators

Lead sponsor

University of Texas Southwestern Medical Center

Other

Collaborators

  • Medtronic

Registry information

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Dec 26, 2018
Registry last updated
Dec 26, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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