TRADE HF: TReatment of Atrial Fibrillation With Dual dEfibrillator in Heart Failure Patients

• Sponsor: Boston Scientific Corporation (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00345592
• Collaborator: (none)
• Enrollment: 420
• Locations: 2
• Arms: 2
• Duration (Months): 73
• Patients Per Site: 210
• Patients Per Site Per Month: 2.9

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Heart Failure, Congestive	Device: Dual (atrial and ventricular) implantable defibrillator; Device: Dual (atrial and ventricular) implantable defibrillator; Device: Dual (atrial and ventricular) implantable defibrillator	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 420 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: TReatment of Atrial Fibrillation With Dual dEfibrillator in Heart Failure Patients
• Study Start Date: Oct 1, 2006
• Actual Primary Completion Date: Nov 1, 2012
• Actual Study Completion Date: Nov 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Device managed arm Device-managed therapy arm. Shock therapy for atrial arrhythmias is delivered automatically from the device.	Device: Dual (atrial and ventricular) implantable defibrillator; The devices automatically applies therapy (shock) for atrial fibrillation, when atrial fibrillation is confirmed.
Active Comparator: Traditional arm 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; In hospital application of anti arrhythmic therapies via the device; 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

Outcome Measures

Primary Outcome Measures

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)]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

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

Sponsors and Collaborators

• Boston Scientific Corporation

Investigators

• Principal Investigator: Gianluca Botto, MD, Azienda Ospedale S. Anna
• Principal Investigator: Luigi Padeletti, MD, Istituto di Clinica Medica I° e Cardiologia A.O.C. Careggi

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Boston Scientific Corporation
• ClinicalTrials.gov Identifier: NCT00345592
• Other Study ID Numbers: 2005_TH
• First Posted: Jun 28, 2006
• Last Update Posted: Mar 28, 2017
• Last Verified: Feb 1, 2017

• Additional relevant MeSH terms: Heart Failure; Atrial Fibrillation

Study Results

Participant Flow

Recruitment Details	First patient was enrolled on the 3rd of October, 2006. Last patient was enrolled on the 29th of July 2009, for a total of 420 patients.
Pre-assignment Detail	24 subjects were not randomized: 7 died before randomization (causes: 3 cardiac, 2 non-cardiac, 2 unknown); 7 voluntarily withdrew; 5 withdrawn due to AF. 2 had device explanted before randomization; 1 had biventricular pacing turned OFF 1 was withdrawn from the study for inclusion criteria violation; 1 lost to follow up.

Arm/Group Title	Device Managed Arm	Traditional Arm
Arm/Group Description	Device-managed therapy arm. Shock therapy for atrial arrhythmias is delivered automatically from the device. Dual (atrial and ventricular) implantable defibrillator: The devices automatically applies therapy (shock) for atrial fibrillation, when atrial fibrillation is confirmed.	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. 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
Period Title: Overall Study
STARTED	199	197
COMPLETED	174	173
NOT COMPLETED	25	24

Baseline Characteristics

Arm/Group Title	Device Managed Arm	Traditional Arm	Total
Arm/Group Description	Device-managed therapy arm. Shock therapy for atrial arrhythmias is delivered automatically from the device. Dual (atrial and ventricular) implantable defibrillator: The devices automatically applies therapy (shock) for atrial fibrillation, when atrial fibrillation is confirmed.	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. 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	Total of all reporting groups
Overall Participants	199	197	396
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	67 (10)	68 (10)	67 (10)
Sex: Female, Male (Count of Participants)
Female	47 23.6%	38 19.3%	85 21.5%
Male	152 76.4%	159 80.7%	311 78.5%
Region of Enrollment (participants) [Number]
Italy	199 100%	197 100%	396 100%

Outcome Measures

1. Primary Outcome

Title	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)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Device Managed Arm	Traditional Arm
Arm/Group Description	Device-managed therapy arm. Shock therapy for atrial arrhythmias is delivered automatically from the device. Dual (atrial and ventricular) implantable defibrillator: The devices automatically applies therapy (shock) for atrial fibrillation, when atrial fibrillation is confirmed.	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. 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
Measure Participants	199	197
Number [participants]	43 21.6%	44 22.3%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Device Managed Arm, Traditional Arm
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	0.987
	Confidence Interval	(2-Sided) 95%; 0.684 to 1.503
	Parameter Dispersion	Type: Value:
	Estimation Comments

Adverse Events

Arm/Group Title	Device Managed Arm		Traditional Arm
Arm/Group Description	Device-managed therapy arm. Shock therapy for atrial arrhythmias is delivered automatically from the device. Dual (atrial and ventricular) implantable defibrillator: The devices automatically applies therapy (shock) for atrial fibrillation, when atrial fibrillation is confirmed.		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. 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
All Cause Mortality
	Device Managed Arm		Traditional Arm
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Device Managed Arm		Traditional Arm
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	103/199 (51.8%)		93/197 (47.2%)
Cardiac disorders
atrial fibrillation	10/199 (5%)	11	7/197 (3.6%)	9
worsening of cardiac disorders	16/199 (8%)	16	14/197 (7.1%)	14
transplant	6/199 (3%)	6	4/197 (2%)	4
General disorders
hopspitalizatin/intervention	78/199 (39.2%)	85	58/197 (29.4%)	74
worsening of non-cardiac disorders	8/199 (4%)	8	10/197 (5.1%)	10
worsening of unknown conditions leading to death	13/199 (6.5%)	13	7/197 (3.6%)	7
Other (Not Including Serious) Adverse Events
	Device Managed Arm		Traditional Arm
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	39/199 (19.6%)		22/197 (11.2%)
Cardiac disorders
device reprogramming	16/199 (8%)	17	14/197 (7.1%)	15
General disorders
clinical observation	24/199 (12.1%)	24	8/197 (4.1%)	8

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.