Paroxysmal Atrial Fibrillation
Conditions
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.
Interventions
Pulmonary vein isolation will be performed with the DiamondTemp™ Ablation System
Sponsors
Medtronic Cardiac Ablation Solutions
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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 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
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Freedom from Atrial Fibrillation (AF) /Atrial Flutter (AFL) /Atrial Tachycardia (AT) | 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 | 12 months | Estimate primary safety adverse event rate for ablation using the DiamondTemp™ Ablation System through 12 months. |
Countries
France, Italy, United States
Contacts
STUDY_DIRECTORKhaldoun Tarakji, MD
Medtronic CAS Chief Medical Officer
Outcome results
None listed