Heart Failure, CongestivePhase 4TRADE HFNCT00345592
TReatment of Atrial Fibrillation With Dual dEfibrillator in Heart Failure Patients
A Phase 4 study testing Dual (atrial and ventricular) implantable defibrillator in people with Heart Failure, Congestive, run by Boston Scientific Corporation at 2 sites in Italy.
Trial summary
Demonstrate the efficacy of the device-based managed therapy to treat atrial tachycardia and fibrillation (AT/AF) in patients with CHF indication for implant of a CRT defibrillator and to demonstrate the advantage of automatic electrical therapy of atrial arrhythmias compared to an in-hospital approach for treatment… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure, Congestive
- What is being tested?
- Dual (atrial and ventricular) implantable defibrillator
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 420 participants
- Where
- 2 sitesItaly
- Study dates
- Oct 2006to Nov 2012
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- chronic symptomatic HF despite stable, optimal drug therapy
- indication for a cardiac resynchronisation device with defibrillator backup according to current guidelines
- patients implanted with cardiac resynchronization device with dual (atrial and ventricular) defibrillation capabilities
Who cannot join
- Chronic atrial fibrillation
- Valvular disease
- patients who underwent or are planned for ablation of atrial fibrillation
- cerebral vascular accident/transient ischemic attack within 12 months from implant which lead to relevant impairment
- preexisting unipolar pacemaker
Trial locations and contacts
2 sites in 1 country.
Italy2 sites
Istituto di Clinica Medica I° e Cardiologia A.O.C.
Careggi
Azienda Ospedale S. Anna
San Fermo Della Battaglia (CO)
About this study
Demonstrate the efficacy of the device-based managed therapy to treat atrial tachycardia and fibrillation (AT/AF) in patients with CHF indication for implant of a CRT defibrillator and to demonstrate the advantage of automatic electrical therapy of atrial arrhythmias compared to an in-hospital approach for treatment of symptomatic AT/AF.
- Conditions
- Heart Failure, Congestive
- Being tested
- Dual (atrial and ventricular) implantable defibrillator
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dual (atrial and ventricular) implantable defibrillatorDevice
The devices automatically applies therapy (shock) for atrial fibrillation, when atrial fibrillation is confirmed.
Dual (atrial and ventricular) implantable defibrillatorDevice
In hospital application of anti arrhythmic therapies via the device
Dual (atrial and ventricular) implantable defibrillatorDevice
Therapy for atrial arrhythmias will be delivered from the device through command of the physician and in a hospital environment
| Study group | Role | What they receive |
|---|---|---|
| Device managed arm | Experimental | Device-managed therapy arm. Shock therapy for atrial arrhythmias is delivered automatically from the device. Receives: Device: Dual (atrial and ventricular) implantable defibrillator |
| Traditional arm | Active comparator | Traditional therapy arm. In this arm, therapy for atrial arrhythmias will be delivered from the device through command of the physician and in a hospital environment. Therefore, patients who will experience symptoms at home, will refer to their center, eventually hospitalized and treated for atrial arrhythmias. Receives: Device: Dual (atrial and ventricular) implantable defibrillator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Unplanned Hospital Admissions for Cardiac Reasons OR Death of Cardiovascular Causes OR Progression to Chronic Atrial Fibrillation
Measured: 3 years from randomization (39 months total)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2006 (estimated)
- Study startOct 2006
- Primary completionNov 2012
- Study completionNov 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Heart Failure, CongestiveStudies of the same condition, open and under way.
- More trials run by Boston Scientific CorporationThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 420 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Scientific Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gianluca Botto, MD, Principal investigator, Azienda Ospedale S. AnnaLuigi Padeletti, MD, Principal investigator, Istituto di Clinica Medica I° e Cardiologia A.O.C. Careggi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00345592
- Sponsor's protocol ID
- 2005_TH
- Acronym
- TRADE HF
- Status last verified
- Feb 2017
- First submitted
- 27 Jun 2006
- Last updated
- 28 Mar 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Botto GL, Boriani G, Favale S, Landolina M, Molon G, Tondo C, Biffi M, Grandinetti G, De Filippo P, Raciti G, Padeletti L. Treatment of atrial fibrillation with a dual defibrillator in heart failure patients (TRADE HF): protocol for a randomized clinical trial. Trials. 2011 Feb 15;12:44. doi: 10.1186/1745-6215-12-44.
PubMed 21324118
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TReatment of Atrial Fibrillation With Dual dEfibrillator in Heart Failure Patients
- ClinicalTrials.gov ID
- NCT00345592
- Acronym / sponsor ID
- TRADE HF / 2005_TH
- Conditions
- Heart Failure, Congestive
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 420 participants (actual)
- Lead sponsor
- Boston Scientific CorporationIndustry (pharma, biotech, devices)
- Study start
- Oct 2006
- Primary completion
- Nov 2012 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 28 Jun 2006 (estimated)
- Results
- Posted 11 Jun 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Demonstrate the efficacy of the device-based managed therapy to treat atrial tachycardia and fibrillation (AT/AF) in patients with CHF indication for implant of a CRT defibrillator and to demonstrate the advantage of automatic electrical therapy of atrial arrhythmias compared to an in-hospital approach for treatment of symptomatic AT/AF.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Device managed arm | Experimental | Device: Dual (atrial and ventricular) implantable defibrillatorDevice-managed therapy arm. Shock therapy for atrial arrhythmias is delivered automatically from the device. |
| Traditional arm | Active comparator | Device: Dual (atrial and ventricular) implantable defibrillatorTraditional therapy arm. In this arm, therapy for atrial arrhythmias will be delivered from the device through command of the physician and in a hospital environment. Therefore, patients who will experience symptoms at home, will refer to their center, eventually hospitalized and treated for atrial arrhythmias. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- chronic symptomatic HF despite stable, optimal drug therapy
- indication for a cardiac resynchronisation device with defibrillator backup according to current guidelines
- patients implanted with cardiac resynchronization device with dual (atrial and ventricular) defibrillation capabilities
Key exclusion criteria (5 listed)
- Chronic atrial fibrillation
- Valvular disease
- patients who underwent or are planned for ablation of atrial fibrillation
- cerebral vascular accident/transient ischemic attack within 12 months from implant which lead to relevant impairment
- preexisting unipolar pacemaker
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 |
|---|---|---|
| Dual (atrial and ventricular) implantable defibrillatorThe devices automatically applies therapy (shock) for atrial fibrillation, when atrial fibrillation is confirmed. | Device | Device managed arm |
| Dual (atrial and ventricular) implantable defibrillatorIn hospital application of anti arrhythmic therapies via the device | Device | Traditional arm |
| Dual (atrial and ventricular) implantable defibrillatorTherapy for atrial arrhythmias will be delivered from the device through command of the physician and in a hospital environment | Device | Traditional arm |
Primary outcome
Unplanned Hospital Admissions for Cardiac Reasons OR Death of Cardiovascular Causes OR Progression to Chronic Atrial Fibrillation
Time frame: 3 years from randomization (39 months total)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 21324118Botto GL, Boriani G, Favale S, Landolina M, Molon G, Tondo C, Biffi M, Grandinetti G, De Filippo P, Raciti G, Padeletti L. Treatment of atrial fibrillation with a dual defibrillator in heart failure patients (TRADE HF): protocol for a randomized clinical trial. Trials. 2011 Feb 15;12:44. doi: 10.1186/1745-6215-12-44.
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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.
Gianluca Botto, MD principal investigator
Azienda Ospedale S. Anna
Luigi Padeletti, MD principal investigator
Istituto di Clinica Medica I° e Cardiologia A.O.C. Careggi
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dual (atrial and ventricular) implantable defibrillator in people with Heart Failure, Congestive, run by Boston Scientific Corporation at 2 sites 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 3 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 28 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 Jun 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Unplanned Hospital Admissions for Cardiac Reasons OR Death of Cardiovascular Causes OR Progression to Chronic Atrial Fibrillation (time frame: 3 years from randomization (39 months total)). 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 NCT00345592, which also lists 1 linked publication.
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 28 Mar 2017.