Dual chamber and atrial tachyarrhythmias adverse events study

Completed

Conditions: Tachyarrythmia
Tachyarrythmias, automatic implantable cardioverter defibrilator (ICD)
Circulatory System

Registration Number: ISRCTN82728969

Lead Sponsor: Medtronic Inc. (USA)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 360

Inclusion Criteria

Meet Class I implantation criteria for single chamber implantable cardioverter defibrillator according to guidelines

Exclusion Criteria

1. Permanent atrial fibrillation
2. Non structural heart disease
3. Patient meets implantation criteria for dual-chamber pacing (symptomatic sinus node disease, all 2nd atrioventricular (AV) block [except asymptomatic Mobitz I] and all 3rd degree AV block)
4. Previous system implanted (ICD or pacemaker)
5. Mechanical right heart valve
6. Medical conditions that would preclude the testing required by the protocol, or limit study participation
7. Unwilling or unable to cooperate or give written informed consent, or the patient is a minor and legal guardians refuse to give informed consent
8. Inaccessible for follow-up at the study centre
9. Biventricular stimulation or re-synchronisation
10. Enrolled or planning to enrol in other clinical trials during the clinical study

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To determine whether use of DDED ICD results in a significant decrease in the number of clinically significant adverse events (CSAE) as follows: <br>1. All-cause mortality<br>2. Invasive intervention, hospitalisation (greater than 24 hours) or prolongation of hospitalisation due to cardiovascular cause<br>3. Inappropriate shocks (two or more episodes with inappropriate shocks)<br>4. Sustained symptomatic atrial tachyarrhythmias that:<br>4.1. Require urgent termination, or <br>4.2. Last more than 48 hours leading to therapeutic intervention

Secondary Outcome Measures

Name	Time	Method
1. Number of each of the components of the CSAE<br>2. Arrhythmia related: <br>2.1. Atrial tachyarrhythmia<br>2.2. Frequency and burden<br>2.3. Ventricular tachyarrhythmia frequency and burden number of appropriate shocks<br>2.4. Number of inappropriate shocks<br>2.5. Need for reprogramming<br>2.6. Need for medication/radiofrequency ablation (RFA) for arrhythmia control<br>2.7. Pacemaker syndrome<br>2.8. Development of dual chamber pacing indication<br>3. Cardiovascular related: <br>3.1. New York Heart Association (NYHA) functional class<br>3.2. Exercise capacity<br>3.3. Left ventricular ejection fraction (LVEF)<br>3.4. Reduction of medication (diuretics)<br>4. Quality of life: <br>4.1. Evaluated by the 36-item Short Form Health Survey (SF-36)<br>4.2. Minnesota living test, with heart failure and Symptom Checklist instruments