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N/A N=25 Randomized Treatment

Minimally Invasive Surgical Treatment Versus Medical Management for Stroke Patients With Atrial Fibrillation

Atrial Fibrillation · Stroke

Bottom Line

View on ClinicalTrials.gov: NCT01442181 ↗
Enrolled (actual)
25
Serious AEs
8.0%
Results posted
Jul 2015
Primary outcome: Primary: Quality of Life RAND 36-Item Health Survey — 33; 46.25; 49.5; 49.16 units on a scale — p=0.03

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
Minimally Invasive Surgery (Procedure); Medical therapy (Other)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
University of Florida
Primary completion
Nov 2013

Outcome Measures

OutcomeResultp-value
PRIMARY
Quality of Life RAND 36-Item Health Survey		 33; 46.25; 49.5; 49.16; 55.5; 54.37 0.03 sig

Summary

The purpose of this study is to compare a minimally invasive surgical procedure and medication management in stroke patients with Atrial Fibrillation. The two treatment options are a minimally invasive surgical procedure or the use of medications.

Eligibility Criteria

Inclusion Criteria

  • Patients with a history of stroke and paroxysmal, persistent or permanent AF.
  • Ischemic stroke or TIA with documented paroxysmal or persistent atrial fibrillation. A TIA will meet inclusion criteria as a sudden-onset focal neurological symptom or sign lasting at least 10 minutes but less than 24 hours with or without evidence of acute brain ischemia on diffusion weighted MRI imaging.
  • Eligible symptoms INCLUDE hemiplegia or hemiparesis, monoplegia, or language disturbance other than isolated dysarthria.
  • Symptoms that will NOT QUALIFY AS TIA INCLUDE transient monocular blindness in both eyes, dysarthria, vertigo,isolated sensory symptoms, confusion, memory loss, nonspecific complaints of dizziness, or syncope.

Exclusion Criteria

  • Recent stroke ( 80 years; Ejection Fraction 55mm.
  • Contraindication to anticoagulation with Coumadin.
  • Mitral insufficiency (> 2+)
  • • • Contraindications to MRI
  • •Artificial heart valve prosthesis
  • Aneurysm clips
  • Implanted drug infusion device or pump
  • Any type of neurotranstimulator
  • Any type of bone growth stimulator
  • Cochlear implants or inner ear prosthesis
  • Any intravascular coils, filters, or stents
  • Shrapnel or bullets
  • Other metallic implants or devices specify which
  • Permanently tattooed eyeliner
  • Are you pregnant or suspect to be pregnant?
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01442181). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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