ArrhythmiaNCT04735016
DiamondTemp Global Registry
An observational study of Arrhythmia, run by Medtronic Cardiac Ablation Solutions at 21 sites in 12 countries.
Trial summary
The DiamondTemp™ Global Registry is a prospective, global, multi-center, observational post-market registry. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Arrhythmia
- What is being tested?
- DiamondTemp™ Ablation System
- Type of treatment
- Medical device
- How many people
- 545 participants
- Where
- 21 sitesin 12 countries
- Study dates
- 22 Apr 2021to Mar 2031
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 (or minimum age as required by local regulations) 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
- Subject is ≥ 18 years of age or minimum age as required by local regulations
- Planned procedure using commercially available DiamondTemp™ Ablation System
- Willing to comply with study requirements and give IC (defined as legally effective, documented confirmation of a subject's voluntary agreement to participate in this clinical study) or authorization per institution and geographical requirements
Who cannot join
- Subject is enrolled in a concurrent study that has not been approved for concurrent enrollment by the global study manager
- Subject with exclusion criteria required by local law
Trial locations and contacts
21 sites in 12 countries.
21 sites in 12 countries
Germany3 sites
Herz- und Diabeteszentrum NRW - Ruhr-Universität Bochum
Bad Oeynhausen, 32545
Universitäres Herzzentrum
Hamburg, 20246
Saint Vincenz Krankenhaus Paderborn
Paderborn, 33098
Italy3 sites
Humanitas Mater Domini
Castellanza, 21053
Ospedale di Conegliano - S. Maria dei Battuti
Conegliano, 31015
Ospedale dell'Angelo
Venezia, 21053
Australia2 sites
Sunshine Coast University Hospital
Birtinya, QLD 4757
Fiona Stanley Hospital
Murdoch, 6150
France2 sites
CHRU de Tours - Hôpital Trousseau
Chambray-lès-Tours, 37170
Capio - Clinique du Tonkin
Villeurbanne, 69300
Netherlands2 sites
Catharina Ziekenhuis
Eindhoven, 5623
St. Antonius Ziekenhuis Nieuwegein
Nieuwegein, 3435 CM
Spain2 sites
Hospital de la Santa Creu I Sant Pau
Barcelona, 08025
Hospital Universitario 12 de Octubre
Madrid, 28041
United Kingdom2 sites
Royal Sussex County Hospital
Brighton, BN2 5BE
University Hospitals Coventry & Warwickshire
Coventry, CV2 2DX
About this study
The DiamondTemp™ Global Registry is a prospective, global, multi-center, observational post-market registry.
Read the detailed description
The DiamondTemp™ Global Registry is a prospective, global, multi-center, observational post-market registry. The purpose of this clinical study is to describe clinical performance and safety data in a broad patient population treated with the commercially available DiamondTemp™ Family of Cardiac Ablation Catheters (hereafter referred to as the DiamondTemp™ Ablation System) and followed according to the standard of care at each respective institution. The follow up period is intended to align with standard practice and subjects will be followed for a minimum of 12 months post-procedure.
- Conditions
- Arrhythmia
- Being tested
- DiamondTemp™ Ablation System
- Medical subject headings
- Arrhythmias, Cardiac
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DiamondTemp™ Ablation SystemDevice
A cardiac ablation will be performed using the DiamondTemp™ Ablation System.
| Study group | Role | What they receive |
|---|---|---|
| Treatment Arm | Patients enrolled and treated with the DiamondTemp™ Ablation System Receives: Device: DiamondTemp™ Ablation System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Freedom from Recurrence at 12 Months
Estimate the 12-month freedom from recurrence of the arrhythmia(s) treated at the study index ablation procedure using the DiamondTemp™ Ablation System.
Measured: 12 Months
Freedom from Device / Procedure Related Adverse Events
Estimate serious device and serious procedure-related adverse events 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 posted2 Feb 2021
- Study start22 Apr 2021
- Primary completionMar 2031 (estimated)
- Study completionMar 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ArrhythmiaStudies of the same condition, open and under way.
- More trials run by Medtronic Cardiac Ablation SolutionsThe sponsor's other registered studies.
- 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
- 545 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Medtronic Cardiac Ablation Solutions
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04735016
- Sponsor's protocol ID
- MDT20059
- Status last verified
- Feb 2026
- First submitted
- 28 Jan 2021
- Last updated
- 27 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- DiamondTemp Global Registry
- ClinicalTrials.gov ID
- NCT04735016
- Acronym / sponsor ID
- MDT20059
- Conditions
- Arrhythmia
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 545 participants (estimated)
- Lead sponsor
- Medtronic Cardiac Ablation SolutionsIndustry (pharma, biotech, devices)
- Study start
- 22 Apr 2021 (actual)
- Primary completion
- Mar 2031 (estimated)
- Study completion
- Mar 2031 (estimated)
- First posted
- 2 Feb 2021 (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 DiamondTemp™ Global Registry is a prospective, global, multi-center, observational post-market registry.
Detailed description
The DiamondTemp™ Global Registry is a prospective, global, multi-center, observational post-market registry. The purpose of this clinical study is to describe clinical performance and safety data in a broad patient population treated with the commercially available DiamondTemp™ Family of Cardiac Ablation Catheters (hereafter referred to as the DiamondTemp™ Ablation System) and followed according to the standard of care at each respective institution. The follow up period is intended to align with standard practice and subjects will be followed for a minimum of 12 months post-procedure.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment Arm | – | Device: DiamondTemp™ Ablation SystemPatients enrolled and treated with the DiamondTemp™ Ablation System |
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 (or minimum age as required by local regulations) who have a recommendation for an ablation with the DiamondTemp™ Ablation System may be approached regarding enrollment in this study.
Key inclusion criteria (3 listed)
- Subject is ≥ 18 years of age or minimum age as required by local regulations
- Planned procedure using commercially available DiamondTemp™ Ablation System
- Willing to comply with study requirements and give IC (defined as legally effective, documented confirmation of a subject's voluntary agreement to participate in this clinical study) or authorization per institution and geographical requirements
Key exclusion criteria (2 listed)
- Subject is enrolled in a concurrent study that has not been approved for concurrent enrollment by the global study manager
- Subject with exclusion criteria required by local law
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 SystemA cardiac ablation will be performed using the DiamondTemp™ Ablation System. | Device | Treatment Arm |
Primary outcome
Freedom from Recurrence at 12 Months
Time frame: 12 Months
Estimate the 12-month freedom from recurrence of the arrhythmia(s) treated at the study index ablation procedure using the DiamondTemp™ Ablation System.
Freedom from Device / Procedure Related Adverse Events
Time frame: 12 Months
Estimate serious device and serious procedure-related adverse events for ablation using the DiamondTemp™ Ablation System through 12 months.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 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.
The record lists no contact. Use the official record to reach the sponsor.
21 sites in 12 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Arrhythmia, run by Medtronic Cardiac Ablation Solutions at 21 sites in 12 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 3 inclusion and 2 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: under way, not looking for participants, as of the sponsor's last update on 27 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 sites in Germany, Italy, Australia, France, Netherlands and 7 more countries. 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?
This study is still under way. Results are not available in the source record yet.
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 Recurrence at 12 Months (time frame: 12 Months). 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 27 May 2026.