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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 : April 30, 2024
Sponsor:
Information provided by (Responsible Party):
Medtronic Cardiac Rhythm and Heart Failure

Tracking Information
First Submitted Date January 27, 2022
First Posted Date February 9, 2022
Last Update Posted Date April 30, 2024
Actual Study Start Date February 28, 2022
Estimated Primary Completion Date January 2029   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: January 28, 2022)
  • 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.
  • 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.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title DIAMOND AF Post-Approval Study
Official Title DIAMOND AF Post-Approval Study
Brief Summary The DIAMOND AF Post Approval study is a prospective, global, multi-center, non-randomized, single-arm observational trial
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 Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition Paroxysmal Atrial Fibrillation
Intervention Device: DiamondTemp™ Ablation System
Pulmonary vein isolation will be performed with the DiamondTemp™ Ablation System
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: January 28, 2022)		 225
Original Estimated Enrollment Same as current
Estimated Study Completion Date January 2029
Estimated Primary Completion Date January 2029   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion 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

Exclusion Criteria:

  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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Ryan Radtke 712.941.9372 ryan.s.radtke@medtronic.com
Contact: Mary Sauline mary.k.sauline@medtronic.com
Listed Location Countries France,   Greece,   Italy,   United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT05230524
Other Study ID Numbers DIAMOND AF PAS
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
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
IPD Sharing Statement Not Provided
Current Responsible Party Medtronic Cardiac Rhythm and Heart Failure
Original Responsible Party Same as current
Current Study Sponsor Medtronic Cardiac Rhythm and Heart Failure
Original Study Sponsor Same as current
Collaborators Not Provided
Investigators
Study Director: Khaldoun Tarakji, MD Medtronic CAS Chief Medical Officer
PRS Account Medtronic Cardiac Rhythm and Heart Failure
Verification Date April 2024