NCT00187252

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
380

participants targeted

Target at P75+ for not_applicable heart-failure

Timeline
Completed

Started Sep 2003

Longer than P75 for not_applicable heart-failure

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2003

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 16, 2005

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2008

Completed
Last Updated

February 4, 2019

Status Verified

February 1, 2019

Enrollment Period

4.8 years

First QC Date

September 13, 2005

Last Update Submit

February 1, 2019

Conditions

Heart FailureAtrial FibrillationVentricular Dysfunction

Keywords

Ventricular Dyssynchrony

Outcome Measures

Primary Outcomes (1)

  • Prevalence of permanent atrial fibrillation

    2 years

Study Arms (2)

1

EXPERIMENTAL

CRT + AF Suppression turned ON

Device: Atrial Overdrive Pacing

2

ACTIVE COMPARATOR

CRT + AF Suppression turned OFF

Device: Atrial Overdrive Pacing

Interventions

Atrial Overdrive PacingDEVICE

Pacemaker/ ICD implant

12

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinica Medica Generale e Cardiologia - Ospedale Careggi

Florence, 50134, Italy

Location

Related Publications (2)

  • Padeletti L, Musilli N, Porciani MC, Colella A, Di Biase L, Ricciardi G, Pieragnoli P, Michelucci A, Gensini G. Atrial fibrillation and cardiac resynchronization therapy: the MASCOT study. Europace. 2004 Sep;5 Suppl 1:S49-54. doi: 10.1016/j.eupc.2004.07.007.

    PMID: 15450280BACKGROUND

  • Padeletti L, Muto C, Maounis T, Schuchert A, Bongiorni MG, Frank R, Vesterlund T, Brachmann J, Vicentini A, Jauvert G, Tadeo G, Gras D, Lisi F, Dello Russo A, Rey JL, Boulogne E, Ricciardi G; Management of Atrial fibrillation Suppression in AF-HF COmorbidity Therapy Study Group. Atrial fibrillation in recipients of cardiac resynchronization therapy device: 1-year results of the randomized MASCOT trial. Am Heart J. 2008 Sep;156(3):520-6. doi: 10.1016/j.ahj.2008.04.013. Epub 2008 Jul 7.

    PMID: 18760135DERIVED

MeSH Terms

Conditions

Heart FailureAtrial FibrillationVentricular Dysfunction

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesArrhythmias, CardiacPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Luigi Padeletti, MD

    Ospedale Carregi, Firenze, Italy

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 16, 2005

Study Start

September 1, 2003

Primary Completion

June 1, 2008

Study Completion

June 1, 2008

Last Updated

February 4, 2019

Record last verified: 2019-02

Locations

IT(1)