Heart FailureMASCOTNCT00187252
Mascot Study: Management of Atrial Fibrillation (AF) Suppression in AF-Heart Failure (HF) COmorbidity Therapy
A study testing Atrial Overdrive Pacing in people with Heart Failure and Atrial Fibrillation, run by Abbott Medical Devices at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure, Atrial Fibrillation, Ventricular Dysfunction
- What is being tested?
- Atrial Overdrive Pacing
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 380 participants
- Where
- 1 siteItaly
- Study dates
- Sep 2003to Jun 2008
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Italy1 site
Clinica Medica Generale e Cardiologia - Ospedale Careggi
Florence, 50134
About this study
Official title: Management of Atrial Fibrillation Suppression in AF-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.
- Conditions
- Heart Failure, Atrial Fibrillation, Ventricular Dysfunction
- Being tested
- Atrial Overdrive Pacing
- Keywords
- Ventricular Dyssynchrony
- Medical subject headings
- Heart Failure, Atrial Fibrillation, Ventricular Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Atrial Overdrive PacingDevice
Pacemaker/ ICD implant
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | CRT + AF Suppression turned ON Receives: Device: Atrial Overdrive Pacing |
| 2 | Active comparator | CRT + AF Suppression turned OFF Receives: Device: Atrial Overdrive Pacing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of permanent atrial fibrillation
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2005 (estimated)
- Study startSep 2003
- Primary completionJun 2008
- Study completionJun 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by Abbott Medical DevicesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 380 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Abbott Medical Devices
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Luigi Padeletti, MD, Principal investigator, Ospedale Carregi, Firenze, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00187252
- Sponsor's protocol ID
- CR03001HF
- Acronym
- MASCOT
- Status last verified
- Feb 2019
- First submitted
- 13 Sep 2005
- Last updated
- 4 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 15450280Padeletti 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.
PubMed 18760135
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Management of Atrial Fibrillation Suppression in AF-HF COmorbidity Therapy
- ClinicalTrials.gov ID
- NCT00187252
- Acronym / sponsor ID
- MASCOT / CR03001HF
- Conditions
- Heart Failure, Atrial Fibrillation, Ventricular Dysfunction
- Keywords
- Ventricular Dyssynchrony
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 380 participants (estimated)
- Lead sponsor
- Abbott Medical DevicesIndustry (pharma, biotech, devices)
- Study start
- Sep 2003
- Primary completion
- Jun 2008 (actual)
- Study completion
- Jun 2008 (actual)
- First posted
- 16 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Device: Atrial Overdrive PacingCRT + AF Suppression turned ON |
| 2 | Active comparator | Device: Atrial Overdrive PacingCRT + AF Suppression turned OFF |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Atrial Overdrive PacingPacemaker/ ICD implant | Device | 1, 2 |
Primary outcome
Prevalence of permanent atrial fibrillation
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2019.
- Background: PubMed 15450280Padeletti 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.
- Derived from this study: PubMed 18760135Padeletti 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Luigi Padeletti, MD principal investigator
Ospedale Carregi, Firenze, Italy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Atrial Overdrive Pacing in people with Heart Failure and Atrial Fibrillation, run by Abbott Medical Devices at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of permanent atrial fibrillation (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00187252, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2019.