TReatment of Atrial Fibrillation With Dual dEfibrillator in Heart Failure Patients

Heart Failure, Congestive Clinical Trial

— TRADE HF  

Official title:

TReatment of Atrial Fibrillation With Dual dEfibrillator in Heart Failure Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00345592
• Other study ID #: 2005_TH
• Status: Completed
• Phase: Phase 4
• First received: June 27, 2006
• Last updated: May 13, 2014
• Start date: October 2006
• Est. completion date: November 2012

Study information

• Verified date: May 2014
• Source: Guidant Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ministry of Health
• Study type: Interventional

Clinical 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 of symptomatic AT/AF.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 420
• Est. completion date: November 2012
• Est. primary completion date: November 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Atrial Fibrillation
• Heart Failure
• Heart Failure, Congestive

Intervention

Device:
• Dual (atrial and ventricular) implantable defibrillator
The devices automatically applies therapy (shock) for atrial fibrillation, when atrial fibrillation is confirmed.
• Dual (atrial and ventricular) implantable defibrillator
In hospital application of anti arrhythmic therapies via the device
• Dual (atrial and ventricular) implantable defibrillator
Therapy for atrial arrhythmias will be delivered from the device through command of the physician and in a hospital environment

Locations

Country	Name	City	State
Italy	Istituto di Clinica Medica I° e Cardiologia A.O.C.	Careggi
Italy	Azienda Ospedale S. Anna	San Fermo della Battaglia (CO)

Sponsors (1)

Lead Sponsor	Collaborator
Guidant Corporation

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Unplanned Hospital Admissions for Cardiac Reasons OR Death of Cardiovascular Causes OR Progression to Chronic Atrial Fibrillation		3 years from randomization (39 months total)	No