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

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ClinicalTrials.gov Identifier: NCT03786822
Recruitment Status : Completed
First Posted : December 25, 2018
Last Update Posted : December 25, 2018
Sponsor:
Collaborator:
Medtronic
Information provided by (Responsible Party):
Richard Wu, University of Texas Southwestern Medical Center

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 Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

Condition 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 : June 1, 2015
Actual Primary Completion Date : December 20, 2016
Actual Study Completion Date : December 20, 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Non-fluoroscopic Cryoballoon PVI
  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
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 Name: 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 Name: Atrial Fibrillation Ablation




Primary Outcome Measures :
  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 Outcome Measures :
  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)



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03786822


Locations
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United States, Texas
University of Texas Southwestern
Dallas, Texas, United States, 75390
Sponsors and Collaborators
University of Texas Southwestern Medical Center
Medtronic

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Responsible Party: Richard Wu, Professor of Internal Medicine, University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT03786822     History of Changes
Other Study ID Numbers: STU 042013-074
First Posted: December 25, 2018    Key Record Dates
Last Update Posted: December 25, 2018
Last Verified: December 2018

Keywords provided by Richard Wu, University of Texas Southwestern Medical Center:
cryoballoon
Atrial fibrillation
pulmonary vein isolation

Additional relevant MeSH terms:
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Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes