Assess Differences in Pain Following Cryo and Radiofrequency Atrial Fibrillation Ablation

NCT ID: NCT03148392

Last Updated: 2019-08-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-05-16

Study Completion Date

2019-12-31

Brief Summary

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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

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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.

Conditions

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Atrial Fibrillation

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Cryo Balloon Ablation

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

No interventions assigned to this group

Radiofrequency Ablation

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

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medtronic

INDUSTRY

Sponsor Role collaborator

Sumit Verma, MD

OTHER

Sponsor Role lead

Responsible Party

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Sumit Verma, MD

Principal Investigator

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Sumit Verma, MD

Role: PRINCIPAL_INVESTIGATOR

Cardiology Consultants

Locations

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Cardiology Consultants

Pensacola, Florida, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Research Manager

Role: CONTACT

850-484-6690

Facility Contacts

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Research Manager

Role: primary

850-484-6690

Other Identifiers

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Cryo RF Ablation QOL

Identifier Type: -

Identifier Source: org_study_id

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