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DIAMOND AF Post-Approval Study (DAF PAS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05230524
Recruitment Status : Recruiting
First Posted : February 9, 2022
Last Update Posted : January 29, 2024
Sponsor:
Information provided by (Responsible Party):
Medtronic Cardiac Rhythm and Heart Failure

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

Condition or disease Intervention/treatment
Paroxysmal Atrial Fibrillation Device: DiamondTemp™ Ablation System

Detailed Description:
The DIAMOND AF PAS is a prospective, global, multi-center, non-randomized, single-arm observational trial. This post approval study is a condition of the Pre-Market Approval order (P200028/S002) by the U.S. Food and Drug Administration." The purpose of this clinical study is to describe clinical performance and safety data in a broad patient population treated with the DiamondTemp™ Ablation System. To assess clinical performance and safety of the DiamondTemp™ Ablation System, study objectives will estimate primary efficacy through 36 months, and primary procedural safety at 12 months. Additionally, study objectives will characterize the ablation procedure, change in QoL through 36 months, single procedure success rate, freedom from symptomatic recurrence, and adverse events (AE) through 36 months.
Study Design
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Study Type : Observational
Estimated Enrollment : 225 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: DIAMOND AF Post-Approval Study
Actual Study Start Date : February 28, 2022
Estimated Primary Completion Date : January 2029
Estimated Study Completion Date : January 2029

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Intervention Details:
  • Device: DiamondTemp™ Ablation System
    Pulmonary vein isolation will be performed with the DiamondTemp™ Ablation System

Outcome Measures
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Primary Outcome Measures :
  1. Freedom from Atrial Fibrillation (AF) /Atrial Flutter (AFL) /Atrial Tachycardia (AT) [ Time Frame: 36 month ]
    Estimate the 36-month freedom from AF/AFL/AT recurrence following ablation procedure using the DiamondTemp™ Ablation System.

  2. Freedom from Primary Safety Events [ Time Frame: 12 months ]
    Estimate primary safety adverse event rate for ablation using the DiamondTemp™ Ablation System through 12 months.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Subjects ≥ 18 years of age who have a recommendation for an ablation with the DiamondTemp™ Ablation System may be approached regarding enrollment in this study.
Criteria

Inclusion Criteria:

  1. A diagnosis of recurrent symptomatic paroxysmal AF:

    a) Symptomatic paroxysmal AF, which is defined as AF that terminates spontaneously or with intervention within 7 days of onset, documented by the following: i) Physician's note indicating at least 2 symptomatic paroxysmal AF episodes occurring within 6 months prior to enrollment; and ii) At least 1 ECG documented AF episode from any form of rhythm monitoring within 12 months prior to enrollment

  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 (or patient's legally authorized representative) is willing and able to provide written informed consent
  6. Patient is willing and able to comply with study requirements

Exclusion Criteria:

  1. Prior persistent AF (continuous AF that is sustained >7 days)
  2. Prior left atrial ablation or left atrial surgical procedure
  3. Presence or likely implant of a permanent pacemaker, biventricular pacemaker, loop recorder, or any type of implantable cardiac defibrillator (with or without biventricular pacing function)
  4. Presence of any pulmonary vein stents
  5. Known presence of any pre-existing pulmonary vein stenosis
  6. Presence of any cardiac valve prosthesis
  7. Any cardiac surgery, myocardial infarction, percutaneous coronary intervention (PCI) /Percutaneous transluminal coronary angioplasty (PTCA) or coronary artery stenting which occurred during the 90 day interval preceding the date the subject signed the Informed Consent Form
  8. Unstable angina
  9. Contraindication to anticoagulation therapy
  10. Active systemic infection
  11. Hypertrophic cardiomyopathy
  12. Any cerebral ischemic event (strokes or Transient Ischemic Attacks (TIA)) which occurred during the 180 day interval preceding the date the patient signed the Informed Consent Form, or any known unresolved complications from previous stroke/TIA
  13. Existing thrombus
  14. Pregnancy
  15. Patient with life expectancy that makes it unlikely 12 months of follow-up will be completed.
  16. 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
  17. Patients with contraindications to a Holter monitor
  18. Unwilling or unable to comply fully with study procedures and follow-up
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05230524


Contacts
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Contact: Ryan Radtke 712.941.9372 ryan.s.radtke@medtronic.com
Contact: Mary Sauline mary.k.sauline@medtronic.com

Locations
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United States, Florida
Florida Electrophysiology LLC Recruiting
Winter Park, Florida, United States, 32792
Contact: Usman Siddiqui, MD    407-670-9507    Siddiqui.u@gmail.com   
Principal Investigator: Usman Siddiqui, MD         
United States, Iowa
Iowa Heart Center (West Des Moines IA) Withdrawn
West Des Moines, Iowa, United States, 50266
United States, Tennessee
University of Tennessee Methodist Physicians Recruiting
Memphis, Tennessee, United States, 38104
Contact: Yehoshua Levine, MD    901-274-2643    ylevine@uthsc.edu   
Principal Investigator: Yehoshua Levine, MD         
France
Centre Hospitalier de Pau - Hôpital François Mitterrand Recruiting
Pau, France, 64046
Contact: Maxime de Guillebon, MD    +33 613613453    maxime.deguillebon@ch-pau.fr   
Reunion University Hospital - Saint Pierre Recruiting
Saint-Pierre Cedex, France, 97448
Contact: Gael Clerici, MD    +33 262692853973    gael.clerici@chu-reunion.fr   
Italy
Azienda Ospedaliero-Universitaria Ospedali Riuniti di Ancona Recruiting
Ancona, Italy, 60030
Contact: Paolo Compagnucci    +39 0715965210    paolo.compagnucci@ospedaliriuniti.marche.it   
Humanitas Mater Domini Recruiting
Varese, Italy, 21053
Contact: Massimo T Tritto, MD         
Principal Investigator: Massimo T Tritto, MD         
Sponsors and Collaborators
Medtronic Cardiac Rhythm and Heart Failure
Investigators
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Study Director: Khaldoun Tarakji, MD Medtronic CAS Chief Medical Officer
More Information
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Responsible Party: Medtronic Cardiac Rhythm and Heart Failure
ClinicalTrials.gov Identifier: NCT05230524    
Other Study ID Numbers: DIAMOND AF PAS
First Posted: February 9, 2022    Key Record Dates
Last Update Posted: January 29, 2024
Last Verified: January 2024

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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.: No
Additional relevant MeSH terms:
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Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes