A Prospective Comparison of Quality of Life Following Atrial Fibrillation Ablation Using the Arctic Front Advance Cryo Balloon Compared to Contact Force Sensing Radiofrequency Catheter Ablation
Sponsor study identifier
observational
100
1 country
1
Study Start
May 16, 2017
Actual (reported)Primary Completion
November 1, 2019
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 31, 2019
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
The primary objective is to assess any differences in patient quality of life between Cryo Balloon ablation and Radiofrequency ablation in the treatment of atrial fibrillation. The study will also assess any differences in the amount and duration of pain medication required after the ablation.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 31, 2019
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
April 27, 2017
Actual (reported)May 11, 2017
Actual (reported)May 16, 2017
Actual (reported)November 1, 2019
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
December 31, 2019
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Pain Intensity Measurement
Self report pain intensity measured at baseline and then once a day beginning at least four hours after the ablation. Three individual pain scales will be used. Universal Pain Assessment Tool is scored 0 to 10 with 0 = no pain and 10 = severe.
7 Days
Health Status and Activity Measurement
7 Days
Pain Medication Assessment
30 Days
Arctic Front Advance Cryo Balloon: Mode of ablation determined based on patient and physician preference
Contact Force Sensing Radiofrequency Catheter Ablation: Mode of ablation determined based on patient and physician preference
Cardiology
Cardiology Consultants
Pensacola, Florida, 32501, United States
Sumit Verma, MD
Cardiology Consultants
First Submitted
April 27, 2017
First Posted
May 11, 2017
Study Start
May 16, 2017
Actual (reported)Primary Completion
November 1, 2019
Estimated (date passed)Comparison of Propofol and Sevoflurane as a Primary Anesthetic for Cardiac Ablation of Atrial Fibrillation.
Contact the study team to confirm eligibility.
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 31, 2019
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
August 28, 2019
Record last verified: 2019-08
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