DIAMOND AF Post-Approval Study (NCT05230524) | Clinical Trial Compass
TerminatedNot Applicable
DIAMOND AF Post-Approval Study
Stopped: Sponsor and FDA agreed on early termination. Results will be posted by the FDA on the FDA Post-Approval Studies (PAS) Database- https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma\_pas.cfm?t\_id=697443\&c\_id=6450
United States, France, Italy84 participantsStarted 2022-02-28
Plain-language summary
The DIAMOND AF Post Approval study is a prospective, global, multi-center, non-randomized, single-arm observational trial
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. A diagnosis of recurrent symptomatic paroxysmal AF
. Failure or intolerance of at least one Class I or III antiarrhythmic drug (including sotalol)
. Patient is ≥ 18 years of age
. Planned procedure for the treatment of AF using commercially available DiamondTemp™ Ablation System
. Patient is willing and able to provide written informed consent
. Patient is willing and able to comply with study requirements
Exclusion criteria
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. Prior persistent AF (continuous AF that is sustained \>7 days)
. Patient with life expectancy that makes it unlikely 36 months of follow-up will be completed.
. Current or anticipated participation in any other clinical trial of a drug, device or biologic during the duration of this study not pre-approved by Medtronic
. Patients with contraindications to a Holter monitor
. Unwilling or unable to comply fully with study procedures and follow-up