Assess Differences in Pain Following Cryo and Radiofrequency Atrial Fibrillation Ablation

Atrial Fibrillation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03148392
• Other study ID #: Cryo RF Ablation QOL
• Status: Recruiting
• Start date: May 16, 2017
• Est. completion date: December 31, 2019

Study information

• Verified date: August 2019
• Source: Langhorne Cardiology Consultants, Inc.
• Contact: Research Manager
• Phone: 850-484-6690
• Email: Jennifer.Lehmann[@]bhcpns.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 31, 2019
• Est. primary completion date: November 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation

Locations

Country	Name	City	State
United States	Cardiology Consultants	Pensacola	Florida

Sponsors (2)

Lead Sponsor	Collaborator
Sumit Verma, MD	Medtronic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	Health Status and Activity Measurement	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.	7 Days
Secondary	Pain Medication Assessment	Assess amount and duration of pain medication required post ablation	30 Days