DiamondTemp™ System for the Treatment of Persistent Atrial Fibrillation

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Medtronic Cardiac Ablation Solutions
Study ID
NCT03643224
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Radiofrequency Ablation — DEVICE
    A procedure will be performed using a radiofrequency ablation catheter.

Study Details

The purpose of the Diamond-AF II study is to establish the safety and effectiveness of the DiamondTemp Ablation System for the treatment of drug refractory, symptomatic persistent atrial fibrillation in patients.

Key Dates

Start date
Sep 19, 2018
Status verified
Oct 2025
Primary completion
Oct 31, 2024
Completion
Oct 31, 2024

Study Design

Enrollment
376 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Experimental
    Radiofrequency Ablation. Catheter ablation to treat persistent atrial fibrillation using temperature-controlled ablation catheter

Primary Outcome Measure

Primary Safety Events [ Time Frame: Ablation through 6 months ]

Locations (15)

FacilityCityStateZIPSite coordinators
Grandview Medical CenterBirminghamAlabama35242-
University Of AlabamaBirminghamAlabama35294-
Keck School Of MedicineLos AngelesCalifornia90033-
Advent Health, Florida Hospital OrlandoOrlandoFlorida32751-
Iowa Heart CenterWest Des MoinesIowa50266-
Kansas City Heart Rhythm InstituteOverland ParkKansas66211-
Massachusetts General HospitalBostonMassachusetts02114-
Jackson Heart ClinicJacksonMississippi39216-
North Mississippi Medical CenterTupeloMississippi38801-
Icahn School of Medicine at Mount SinaiNew YorkNew York10029-
Montefiore Medical CenterNew YorkNew York10467-
Medical University Of South CarolinaCharlestonSouth Carolina29425-
Trident Medical CenterCharlestonSouth Carolina29406-
Texas Cardiac Arrhythmia Research FoundationAustinTexas78705-
Houston Methodist HospitalHoustonTexas77030-

Find similar trials in Birmingham, AL

By condition
Atrial fibrillation
By specialty
CardiologyHeart disease
By research site
Grandview Medical Center· Birmingham, ALUniversity Of Alabama· Birmingham, ALKeck School Of Medicine· Los Angeles, CAAdvent Health, Florida Hospital Orlando· Orlando, FLIowa Heart Center· West Des Moines, IAKansas City Heart Rhythm Institute· Overland Park, KS

Related Studies