Assess Differences in Pain Following Cryo and Radiofrequency Atrial Fibrillation Ablation

August 22, 2019 updated by: Sumit Verma, MD

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

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.

Study Overview

Status

Unknown

Conditions

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 Type

Observational

Enrollment (Anticipated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Pensacola, Florida, United States, 32501
        • Recruiting
        • Cardiology Consultants
        • Contact:
          • Research Manager
          • Phone Number: 850-484-6690

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Cardiology

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Cryo Balloon Ablation
Arctic Front Advance Cryo Balloon: Mode of ablation determined based on patient and physician preference
Radiofrequency Ablation
Contact Force Sensing Radiofrequency Catheter Ablation: Mode of ablation determined based on patient and physician preference

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain Intensity Measurement
Time Frame: 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.
7 Days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Health Status and Activity Measurement
Time Frame: 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.
7 Days
Pain Medication Assessment
Time Frame: 30 Days
Assess amount and duration of pain medication required post ablation
30 Days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sumit Verma, MD

Collaborators

Medtronic

Investigators

  • Principal Investigator: Sumit Verma, MD, Cardiology Consultants

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

May 16, 2017

Primary Completion (ANTICIPATED)

November 1, 2019

Study Completion (ANTICIPATED)

December 31, 2019

Study Registration Dates

First Submitted

April 27, 2017

First Submitted That Met QC Criteria

May 8, 2017

First Posted (ACTUAL)

May 11, 2017

Study Record Updates

Last Update Posted (ACTUAL)

August 28, 2019

Last Update Submitted That Met QC Criteria

August 22, 2019

Last Verified

August 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Cryo RF Ablation QOL

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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