DIAMOND AF Post-Approval Study

Description

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

Conditions

Paroxysmal Atrial Fibrillation

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Study Overview

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Study Details

Study overview

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

DIAMOND AF Post-Approval Study

DIAMOND AF Post-Approval Study

Condition
Paroxysmal Atrial Fibrillation
Intervention / Treatment

-

Contacts and Locations

Winter Park

Florida Electrophysiology LLC, Winter Park, Florida, United States, 32792

West Des Moines

Iowa Heart Center (West Des Moines IA), West Des Moines, Iowa, United States, 50266

Memphis

University of Tennessee Methodist Physicians, Memphis, Tennessee, United States, 38104

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.

For general information about clinical research, read Learn About Studies.

Eligibility 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 de novo pulmonary vein isolation (PVI) procedure 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. Prior left atrial ablation or left atrial surgical procedure
  • 3. Patient with life expectancy that makes it unlikely 36 months of follow-up will be completed.
  • 4. 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
  • 5. Patients with contraindications to a Holter monitor
  • 6. Unwilling or unable to comply fully with study procedures and follow-up

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Medtronic Cardiac Rhythm and Heart Failure,

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

Study Record Dates

2029-01