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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 Delayed
Application Number /
Requirement Number		 P200028 / PAS001
Date Original Protocol Accepted 11/02/2021
Date Current Protocol Accepted 11/16/2022
Study Name DIAMOND AF PAS
Device Name DiamondTemp Ablation System
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 Objectives 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 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.
Key Study Endpoints 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
Interim or Final Data Summary
Actual Number of Patients Enrolled 24
Actual Number of Sites Enrolled 5
Patient Follow-up Rate Study visits will occur at 3, 6, 12, 24, and 36 months, including required 12-lead ECG review at each follow up visit and 24 Holter monitoring at each follow up except the 3 month visit
Final Safety Findings No adverse events have been reported.
Final Effect Findings N/A


DIAMOND AF PAS Reporting Schedule

Reporting 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 11/28/2022 11/29/2022 Overdue/Received
18 month report 05/31/2023 05/25/2023 On Time
2 year report 11/28/2023 11/22/2023 On Time
3 year report 11/28/2024    
4 year report 11/28/2025    


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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