Post-Approval Studies (PAS) Database

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

General
Study Status	Delayed
Application Number / Requirement Number	P200028 / PAS001
Date Original Protocol Accepted	11/02/2021
Date Current Protocol Accepted	10/10/2025
Study Name	DIAMOND AF PAS
Device Name	DiamondTemp Ablation System
Clinical Trial Number(s)	NCT02821351 NCT03334630
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. The study protocol was subsequently modified to limit enrollment to 81 subjects.
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. The study protocol was subsequently modified to limit follow-up following a final adverse event assessment.
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	11/22/2024	On Time
4 year report	11/28/2025	11/21/2025	On Time
5 year report	11/28/2026

Contact Us

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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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• Guidance Document: "Procedures for Handling Post-Approval Studies Imposed by PMA Order"
• PAS Program Background