DIAMOND AF Post-Approval Study (DAF PAS)

  • STATUS
    Recruiting
  • End date
    Aug 16, 2026
  • participants needed
    225
  • sponsor
    Medtronic Cardiac Rhythm and Heart Failure
Updated on 16 October 2022
antiarrhythmic drug
sotalol
pulmonary vein isolation

Summary

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

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.

Details
Condition Paroxysmal Atrial Fibrillation
Treatment DiamondTemp™ Ablation System
Clinical Study IdentifierNCT05230524
SponsorMedtronic Cardiac Rhythm and Heart Failure
Last Modified on16 October 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

A diagnosis of recurrent symptomatic paroxysmal AF
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
Failure or intolerance of at least one Class I or III antiarrhythmic drug (including
sotalol)
Patient is ≥ 18 years of age
Planned de novo pulmonary vein isolation (PVI) procedure using commercially available DiamondTemp™ Ablation System
Patient (or patient's legally authorized representative) is willing and able to provide written informed consent
Patient is willing and able to comply with study requirements

Exclusion Criteria

Prior persistent AF (continuous AF that is sustained >7 days)
Prior left atrial ablation or left atrial surgical procedure
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)
Presence of any pulmonary vein stents
Known presence of any pre-existing pulmonary vein stenosis
Presence of any cardiac valve prosthesis
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
Unstable angina
Contraindication to anticoagulation therapy
Active systemic infection
Hypertrophic cardiomyopathy
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
Existing thrombus
Pregnancy
Patient with life expectancy that makes it unlikely 12 months of follow-up will be completed
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
Patients with contraindications to a Holter monitor
Unwilling or unable to comply fully with study procedures and follow-up
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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