ACTIVE_NOT_RECRUITING

DIAMOND AF Post-Approval Study

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The DIAMOND AF Post Approval study is a prospective, global, multi-center, non-randomized, single-arm observational trial

Official Title

DIAMOND AF Post-Approval Study

Quick Facts

Study Start:2022-02-28

Study Completion:2026-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:ACTIVE_NOT_RECRUITING

Study ID

NCT05230524

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. A diagnosis of recurrent symptomatic paroxysmal AF 2. Failure or intolerance of at least one Class I or III antiarrhythmic drug (including sotalol) 3. Patient is ≥ 18 years of age 4. Planned procedure for the treatment of AF using commercially available DiamondTemp™ Ablation System 5. Patient is willing and able to provide written informed consent 6. Patient is willing and able to comply with study requirements	1. Prior persistent AF (continuous AF that is sustained \>7 days) 2. Patient with life expectancy that makes it unlikely 36 months of follow-up will be completed. 3. 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 4. Patients with contraindications to a Holter monitor 5. Unwilling or unable to comply fully with study procedures and follow-up

Inclusion Criteria

Exclusion Criteria

1. A diagnosis of recurrent symptomatic paroxysmal AF
2. Failure or intolerance of at least one Class I or III antiarrhythmic drug (including sotalol)
3. Patient is ≥ 18 years of age
4. Planned procedure for the treatment of AF using commercially available DiamondTemp™ Ablation System
5. Patient is willing and able to provide written informed consent
6. Patient is willing and able to comply with study requirements

1. Prior persistent AF (continuous AF that is sustained \>7 days)
2. Patient with life expectancy that makes it unlikely 36 months of follow-up will be completed.
3. 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
4. Patients with contraindications to a Holter monitor
5. Unwilling or unable to comply fully with study procedures and follow-up

Contacts and Locations

Principal Investigator

Khaldoun Tarakji, MD

STUDY_DIRECTOR

Medtronic CAS Chief Medical Officer

Study Locations (Sites)

Florida Electrophysiology LLC

Winter Park, Florida, 32792

United States

Collaborators and Investigators

Sponsor: Medtronic Cardiac Ablation Solutions

Khaldoun Tarakji, MD, STUDY_DIRECTOR, Medtronic CAS Chief Medical Officer

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-02-28

Study Completion Date2026-01

Study Record Updates

Study Start Date2022-02-28

Study Completion Date2026-01

Terms related to this study

Additional Relevant MeSH Terms

Paroxysmal Atrial Fibrillation