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U.S. Department of Health and Human Services

Post-Approval Studies (PAS) Database

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The FDA has the authority to require sponsors to perform a post-approval study (or studies) at the time of approval of a premarket approval (PMA), humanitarian device exemption (HDE), or product development protocol (PDP) application. Post-approval studies can provide patients, health care professionals, the device industry, the FDA and other stakeholders information on the continued safety and effectiveness (or continued probable benefit, in the case of an HDE) of approved medical devices. This database allows you to search Post-Approval Study information by applicant or device information.

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DIAMOND AF PAS


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General
Study Status Study Pending
Application Number P200028 / PAS001
Date Current Protocol Accepted  
Study Name DIAMOND AF PAS
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source Sponsor Registry
Comparison Group No Control
Analysis Type Descriptive
Study Population Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Design Description The purpose of the DIAMOND AF Post Approval study is to describe clinical performance and safety data in a broad patient population treated with the DiamondTemp™ Family of Cardiac Ablation Catheters. This clinical study is a prospective, global, multi-center, non-randomized, single-arm observational trial.
Study Population Description Patients greater than or equal to 18 years of age with a diagnosis of recurrent symptomatic AFib with planned de novo pulmonary vein isolation procedure using the DiamondTemp Ablation System.
Sample Size The study is expected to be conducted at a minimum of 6 sites located in multiple geographies and will enroll up to 225 subjects to ensure 175 subjects are treated with ablation. At least 50% of the subjects will be enrolled and treated in the United States.
Data Collection Primary Efficacy

Estimate the 36-month freedom from AF/AFL/AT recurrence following ablation procedure using the DiamondTemp™ Ablation System

Primary Safety

Estimate primary safety adverse event rate for ablation using the DiamondTemp™ Ablation System through 12 months
Follow-up Visits and Length of Follow-up 36 months post-ablation


DIAMOND AF PAS Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
6 month report 05/31/2022 05/27/2022 On Time
1 year report 11/02/2022    


Contact Us

Mandated Studies Program
Food and Drug Administration
10903 New Hampshire Ave.
Silver Spring, MD 20993-0002
Email: MandatedStudiesPrograms@fda.hhs.gov

Additional Resources

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