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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04735016




Registration number
NCT04735016
Ethics application status
Date submitted
28/01/2021
Date registered
2/02/2021
Date last updated
30/04/2024

Titles & IDs
Public title
DiamondTemp Global Registry
Scientific title
DiamondTemp Global Registry
Secondary ID [1] 0 0
MDT20059
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Arrhythmia 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Observational [Patient Registry]
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Treatment: Devices - DiamondTemp™ Ablation System

Treatment Arm - Patients enrolled and treated with the DiamondTemp™ Ablation System


Treatment: Devices: DiamondTemp™ Ablation System
A cardiac ablation will be performed using the DiamondTemp™ Ablation System.
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Freedom from Recurrence at 12 Months
Timepoint [1] 0 0
12 Months
Primary outcome [2] 0 0
Freedom from Device / Procedure Related Adverse Events
Timepoint [2] 0 0
12 Months

Eligibility
Key inclusion criteria
* 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* 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

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
22/04/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/03/2031
Actual
Sample size
Target
1000
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Sunshine Coast University Hospital - Birtinya
Recruitment hospital [2] 0 0
Fiona Stanley Hospital - Murdoch
Recruitment postcode(s) [1] 0 0
QLD 4757 - Birtinya
Recruitment postcode(s) [2] 0 0
6150 - Murdoch
Recruitment outside Australia
Country [1] 0 0
Belgium
State/province [1] 0 0
Jette
Country [2] 0 0
France
State/province [2] 0 0
Chambray-lès-Tours
Country [3] 0 0
France
State/province [3] 0 0
Villeurbanne
Country [4] 0 0
Germany
State/province [4] 0 0
Bad Oeynhausen
Country [5] 0 0
Germany
State/province [5] 0 0
Hamburg
Country [6] 0 0
Germany
State/province [6] 0 0
Paderborn
Country [7] 0 0
Italy
State/province [7] 0 0
Castellanza
Country [8] 0 0
Italy
State/province [8] 0 0
Conegliano
Country [9] 0 0
Italy
State/province [9] 0 0
Venezia
Country [10] 0 0
Netherlands
State/province [10] 0 0
Eindhoven
Country [11] 0 0
Netherlands
State/province [11] 0 0
Nieuwegein
Country [12] 0 0
Poland
State/province [12] 0 0
Katowice
Country [13] 0 0
Slovenia
State/province [13] 0 0
Ljubljana
Country [14] 0 0
Spain
State/province [14] 0 0
Barcelona
Country [15] 0 0
Spain
State/province [15] 0 0
Madrid
Country [16] 0 0
Switzerland
State/province [16] 0 0
Bern
Country [17] 0 0
United Kingdom
State/province [17] 0 0
Brighton
Country [18] 0 0
United Kingdom
State/province [18] 0 0
Coventry

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Medtronic Cardiac Rhythm and Heart Failure
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The DiamondTemp™ Global Registry is a prospective, global, multi-center, observational post-market registry.
Trial website
https://clinicaltrials.gov/study/NCT04735016
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Ryan Radtke
Address 0 0
Country 0 0
Phone 0 0
712.941.9372
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT04735016