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OpenTrials
Completed

NCT Number: NCT00187252

Mascot Study: Management of Atrial Fibrillation (AF) Suppression in AF-Heart Failure (HF) COmorbidity Therapy

The purpose of this study is to evaluate whether adding AF Suppression™ to cardiac resynchronization therapy (CRT) improves the prognosis of heart failure patients benefiting from cardiac resynchronization therapy.

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Key information

Conditions

Heart Failure Arrhythmias, Cardiac Atrial Fibrillation Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Ventricular Dysfunction

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Clinica Medica Generale e Cardiologia - Ospedale Careggi

Florence, 50134, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • HF patients
  • New York Heart Association (NYHA) III - IV
  • Spontaneous QRS ≥130 ms and/or mechanical interventricular delay > 50 ms
  • Left ventricular ejection fraction (LVEF) ≤ 35%
  • Left ventricular end diastolic diameter (LVEDD) ≥ 55 mm
  • Optimized medical regimen
  • Age > 18 years

Exclusion criteria

  • Unstable angina or acute myocardial infarction (MI) (< 3 months)
  • Coronary artery bypass grafting (CABG) or percutaneous transluminal coronary angioplasty (PTCA) < 3 months
  • Life expectancy < 6 months
  • Permanent AF
  • Pregnancy

Treatment and study plan

Atrial Overdrive Pacing

Device

Pacemaker/ ICD implant

Primary outcomes

  1. Prevalence of permanent atrial fibrillation

    Time frame: 2 years

Sponsors and collaborators

Lead sponsor

Abbott Medical Devices

Industry

Registry information

Official study title

Management of Atrial Fibrillation Suppression in AF-HF COmorbidity Therapy

Acronym: MASCOT

Important dates

Study start
2003
Primary completion
2008
Study completion
2008
First posted
Sep 16, 2005
Registry last updated
Feb 4, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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