Assess Differences in Pain Following Cryo and Radiofrequency Atrial Fibrillation Ablation

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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03148392

Enrollment

100

Registered

2017-05-11

Start date

2017-05-16

Completion date

2019-12-31

Last updated

2019-08-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atrial Fibrillation

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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

Countries

United States

Contacts

Primary ContactResearch Manager

Jennifer.Lehmann@bhcpns.org850-484-6690

Outcome results