Paroxysmal Atrial FibrillationDAF PASNCT05230524
DIAMOND AF Post-Approval Study
An observational study of Paroxysmal Atrial Fibrillation, run by Medtronic Cardiac Ablation Solutions at 5 sites in 3 countries.
Trial summary
The DIAMOND AF Post Approval study is a prospective, global, multi-center, non-randomized, single-arm observational trial Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Paroxysmal Atrial Fibrillation
- What is being tested?
- DiamondTemp™ Ablation System
- Type of treatment
- Medical device
- How many people
- 84 participants
- Where
- 5 sitesin 3 countries
- Study dates
- 28 Feb 2022to 17 Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects ≥ 18 years of age who have a recommendation for an ablation with the DiamondTemp™ Ablation System may be approached regarding enrollment in this study.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
5 sites in 3 countries.
5 sites in 3 countries
France2 sites
Centre Hospitalier de Pau - Hôpital François Mitterrand
Pau, 64046
Reunion University Hospital - Saint Pierre
Saint-Pierre, 97448
Italy2 sites
Azienda Ospedaliero-Universitaria Ospedali Riuniti di Ancona
Ancona, 60030
Humanitas Mater Domini
Varese, 21053
United States1 site
Florida Electrophysiology LLC
Winter Park, Florida, 32792
About this study
The DIAMOND AF Post Approval study is a prospective, global, multi-center, non-randomized, single-arm observational trial
Read the detailed description
The DIAMOND AF PAS is a prospective, global, multi-center, non-randomized, single-arm observational trial. This post approval study is a condition of the Pre-Market Approval order (P200028/S002) by the U.S. Food and Drug Administration." The purpose of this clinical study is to describe clinical performance and safety data in a broad patient population treated with the DiamondTemp™ Ablation System. To assess clinical performance and safety of the DiamondTemp™ Ablation System, study objectives will estimate primary efficacy through 36 months, and primary procedural safety at 12 months. Additionally, study objectives will characterize the ablation procedure, change in QoL through 36 months, single procedure success rate, freedom from symptomatic recurrence, and adverse events (AE) through 36 months.
- Conditions
- Paroxysmal Atrial Fibrillation
- Being tested
- DiamondTemp™ Ablation System
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DiamondTemp™ Ablation SystemDevice
Pulmonary vein isolation will be performed with the DiamondTemp™ Ablation System
What is being measured
The primary outcome is the main question the study is designed to answer.
Freedom from Atrial Fibrillation (AF) /Atrial Flutter (AFL) /Atrial Tachycardia (AT)
Estimate the 36-month freedom from AF/AFL/AT recurrence following ablation procedure using the DiamondTemp™ Ablation System.
Measured: 36 month
Freedom from Primary Safety Events
Estimate primary safety adverse event rate for ablation using the DiamondTemp™ Ablation System through 12 months.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2022
- Study start28 Feb 2022
- Primary completion17 Dec 2025
- Study completion17 Dec 2025
Why it 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
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Paroxysmal Atrial FibrillationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic Cardiac Ablation Solutions
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Khaldoun Tarakji, MD, Study director, Medtronic CAS Chief Medical Officer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05230524
- Sponsor's protocol ID
- DIAMOND AF PAS
- Acronym
- DAF PAS
- Status last verified
- Jun 2026
- First submitted
- 27 Jan 2022
- Last updated
- 6 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- DIAMOND AF Post-Approval Study
- ClinicalTrials.gov ID
- NCT05230524
- Acronym / sponsor ID
- DAF PAS / DIAMOND AF PAS
- Conditions
- Paroxysmal Atrial Fibrillation
- Study type
- Observational
- Recruitment status
- TerminatedReason 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
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Medtronic Cardiac Ablation SolutionsIndustry (pharma, biotech, devices)
- Study start
- 28 Feb 2022 (actual)
- Primary completion
- 17 Dec 2025 (actual)
- Study completion
- 17 Dec 2025 (actual)
- First posted
- 9 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The DIAMOND AF Post Approval study is a prospective, global, multi-center, non-randomized, single-arm observational trial
Detailed description
The DIAMOND AF PAS is a prospective, global, multi-center, non-randomized, single-arm observational trial. This post approval study is a condition of the Pre-Market Approval order (P200028/S002) by the U.S. Food and Drug Administration." The purpose of this clinical study is to describe clinical performance and safety data in a broad patient population treated with the DiamondTemp™ Ablation System. To assess clinical performance and safety of the DiamondTemp™ Ablation System, study objectives will estimate primary efficacy through 36 months, and primary procedural safety at 12 months. Additionally, study objectives will characterize the ablation procedure, change in QoL through 36 months, single procedure success rate, freedom from symptomatic recurrence, and adverse events (AE) through 36 months.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects ≥ 18 years of age who have a recommendation for an ablation with the DiamondTemp™ Ablation System may be approached regarding enrollment in this study.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DiamondTemp™ Ablation SystemPulmonary vein isolation will be performed with the DiamondTemp™ Ablation System | Device | – |
Primary outcome
Freedom from Atrial Fibrillation (AF) /Atrial Flutter (AFL) /Atrial Tachycardia (AT)
Time frame: 36 month
Estimate the 36-month freedom from AF/AFL/AT recurrence following ablation procedure using the DiamondTemp™ Ablation System.
Freedom from Primary Safety Events
Time frame: 12 months
Estimate primary safety adverse event rate for ablation using the DiamondTemp™ Ablation System through 12 months.
Results and safety
The study was stopped early (reason given: 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). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Khaldoun Tarakji, MD study director
Medtronic CAS Chief Medical Officer
5 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Paroxysmal Atrial Fibrillation, run by Medtronic Cardiac Ablation Solutions at 5 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 6 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in France, Italy, United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: 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). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Freedom from Atrial Fibrillation (AF) /Atrial Flutter (AFL) /Atrial Tachycardia (AT) (time frame: 36 month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2026.