NCT00345592

Brief 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 of symptomatic AT/AF.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
420

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Oct 2006

Longer than P75 for phase_4

Geographic Reach
1 country

2 active sites

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

First Submitted

Initial submission to the registry

June 27, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 28, 2006

Completed
3 months until next milestone

Study Start

First participant enrolled

October 1, 2006

Completed
6.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2012

Completed
1.6 years until next milestone

Results Posted

Study results publicly available

June 11, 2014

Completed
Last Updated

March 28, 2017

Status Verified

February 1, 2017

Enrollment Period

6.1 years

First QC Date

June 27, 2006

Results QC Date

April 4, 2014

Last Update Submit

February 27, 2017

Conditions

Heart Failure, Congestive

Outcome Measures

Primary Outcomes (1)

  • Unplanned Hospital Admissions for Cardiac Reasons OR Death of Cardiovascular Causes OR Progression to Chronic Atrial Fibrillation

    3 years from randomization (39 months total)

Study Arms (2)

Device managed arm

EXPERIMENTAL

Device-managed therapy arm. Shock therapy for atrial arrhythmias is delivered automatically from the device.

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.

Device: Dual (atrial and ventricular) implantable defibrillator

Interventions

Dual (atrial and ventricular) implantable defibrillatorDEVICE

The devices automatically applies therapy (shock) for atrial fibrillation, when atrial fibrillation is confirmed.

Device managed arm

Eligibility Criteria

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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Istituto di Clinica Medica I° e Cardiologia A.O.C.

Careggi, Italy

Location

Azienda Ospedale S. Anna

San Fermo Della Battaglia (CO), Italy

Location

Related Publications (1)

  • 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.

    PMID: 21324118DERIVED

MeSH Terms

Conditions

Heart Failure

Interventions

Defibrillators, Implantable

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

DefibrillatorsElectrodesElectrical Equipment and SuppliesEquipment and SuppliesElectrodes, ImplantedProstheses and Implants

Results Point of Contact

Title
Giovanni Luca Botto
Organization
S. Anna Hospital
gluca.botto@gmail.com
0315851

Study Officials

  • Gianluca Botto, MD

    Azienda Ospedale S. Anna

    PRINCIPAL INVESTIGATOR

  • Luigi Padeletti, MD

    Istituto di Clinica Medica I° e Cardiologia A.O.C. Careggi

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 27, 2006

First Posted

June 28, 2006

Study Start

October 1, 2006

Primary Completion

November 1, 2012

Study Completion

November 1, 2012

Last Updated

March 28, 2017

Results First Posted

June 11, 2014

Record last verified: 2017-02

Locations

IT(2)