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
1 other identifier
observational
100
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started May 2017
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 27, 2017
CompletedFirst Posted
Study publicly available on registry
May 11, 2017
CompletedStudy Start
First participant enrolled
May 16, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2019
CompletedAugust 28, 2019
August 1, 2019
2.5 years
April 27, 2017
August 22, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
Health Status and Activity Measurement
7 Days
Pain Medication Assessment
30 Days
Study Arms (2)
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
Eligibility Criteria
Cardiology
You may qualify if:
- Paroxysmal atrial fibrillation who are advised either Cryoablation or Radiofrequency ablation for treatment.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Sumit Verma, MDlead
- Medtroniccollaborator
Study Sites (1)
Cardiology Consultants
Pensacola, Florida, 32501, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sumit Verma, MD
Cardiology Consultants
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
April 27, 2017
First Posted
May 11, 2017
Study Start
May 16, 2017
Primary Completion
November 1, 2019
Study Completion
December 31, 2019
Last Updated
August 28, 2019
Record last verified: 2019-08
Data Sharing
- IPD Sharing
- Will not share