Assess Differences in Pain Following Cryo and Radiofrequency Atrial Fibrillation Ablation

• Conditions: Atrial Fibrillation

• Registration Number: NCT03148392
• Lead Sponsor: Sumit Verma, MD

Brief Summary

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.

Detailed Description

Currently there are several different accepted techniques for performing ablation of atrial fibrillation. The two primary techniques currently in use in our center for atrial fibrillation are Cryo Balloon and Radiofrequency ablation.

Based on personal observation, it is felt that patients undergoing Radiofrequency ablation have a higher incidence of chest discomfort and subsequently a greater requirement for pain medications post procedure as compared to those patients undergoing Cryo ablation.

Study Timeline

• Study First Submitted: 2017-04-27
• Study First Submitted QC: 2017-05-08
• Study First Posted: 2017-05-11
• Study Start: 2017-05-16
• Status Verified: 2019-08
• Last Update Submitted: 2019-08-22
• Last Update Posted: 2019-08-28
• Primary Completion: 2019-11-01
• Study Completion: 2019-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Paroxysmal atrial fibrillation who are advised either Cryoablation or Radiofrequency ablation for treatment.

Exclusion Criteria

• Persistent atrial fibrillation
• Pregnant
• Taking pain medications for acute or chronic conditions at the time of the procedure.
• Undergo a combination of Cryoablation and Radiofrequency ablation
• Radiofrequency group who undergo ablation beyond pulmonary vein isolation

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Pain Intensity Measurement	7 Days	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.

Secondary Outcome Measures

Name	Time	Method
Health Status and Activity Measurement	7 Days	Self report health status and activity measured at baseline and then once a day beginning at least four hours after the ablation using SF-36 Health and Well-Being Questionnaire.
Pain Medication Assessment	30 Days	Assess amount and duration of pain medication required post ablation

Trial Locations

Locations (1)

Cardiology Consultants; 🇺🇸 Pensacola, Florida, United States