DiamondTemp Global Registry

• Sponsor: Medtronic Cardiac Rhythm and Heart Failure (Industry)
• Overall Status: Recruiting
• CT.gov ID: NCT04735016
• Collaborator: (none)
• Enrollment: 1,000
• Location: 1
• Anticipated Duration (Months): 118.3
• Patients Per Site Per Month: 8.5

Study Details

Study Description

Brief Summary

The DiamondTemp™ Global Registry is a prospective, global, multi-center, observational post-market registry.

Condition or Disease	Intervention/Treatment	Phase
Arrhythmia	Device: DiamondTemp™ Ablation System

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

• Study Type: Observational [Patient Registry]
• Anticipated Enrollment: 1000 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: DiamondTemp Global Registry
• Actual Study Start Date: Apr 22, 2021
• Anticipated Primary Completion Date: Mar 1, 2031
• Anticipated Study Completion Date: Mar 1, 2031

Arms and Interventions

Arm	Intervention/Treatment
Treatment Arm Patients enrolled and treated with the DiamondTemp™ Ablation System	Device: DiamondTemp™ Ablation System; A cardiac ablation will be performed using the DiamondTemp™ Ablation System.

Outcome Measures

Primary Outcome Measures

1. Freedom from Recurrence at 12 Months [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.

2. Freedom from Device / Procedure Related Adverse Events [12 Months]

   Estimate serious device and serious procedure-related adverse events for ablation using the DiamondTemp™ Ablation System through 12 months.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Universitair Ziekenhuis Brussel	Brussel		Belgium	1090

Sponsors and Collaborators

• Medtronic Cardiac Rhythm and Heart Failure

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Medtronic Cardiac Rhythm and Heart Failure
• ClinicalTrials.gov Identifier: NCT04735016
• Other Study ID Numbers: MDT20059
• First Posted: Feb 2, 2021
• Last Update Posted: Jul 1, 2021
• Last Verified: Jun 1, 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: Yes
• Additional relevant MeSH terms: Arrhythmias, Cardiac

Study Results

No Results Posted as of Jul 1, 2021