Assess Differences in Pain Following Cryo and Radiofrequency Atrial Fibrillation Ablation

Sumit Verma, MD

Status: Unknown

Conditions: Atrial Fibrillation

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT03148392

Cryo RF Ablation QOL

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No 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

Trial design

100 participants in 2 patient groups

Cryo Balloon Ablation

Description:

Arctic Front Advance Cryo Balloon: Mode of ablation determined based on patient and physician preference

Radiofrequency Ablation

Description:

Contact Force Sensing Radiofrequency Catheter Ablation: Mode of ablation determined based on patient and physician preference