Trial Outcomes & Findings for AVAI: Atrial Ventricular Arrythmia Incidence (NCT NCT00832975)

NCT ID: NCT00832975

Last Updated: 2019-02-21

Results Overview

Slow Ventricular Tachycardia episodes will be considered as a tachycardia episodes detected by the device between 120-150 bpm and with more than 30sec of duration AF Episodes will be considered only when their duration is \>30sec

• Recruitment status: COMPLETED
• Target enrollment: 157 participants
• Primary outcome timeframe: 24 months
• Results posted on: 2019-02-21

Participant Flow

Participant milestones

Measure	St Jude Medical ICD/CRT-D St Jude Medical Implantable Cardioverter Defibrillator (ICD) / Cardiac Resynchronization Therapy-Defibrillator (CRT-D) Device implanted patients
Overall Study STARTED	157
Overall Study COMPLETED	118
Overall Study NOT COMPLETED	39

Reasons for withdrawal

Measure	St Jude Medical ICD/CRT-D St Jude Medical Implantable Cardioverter Defibrillator (ICD) / Cardiac Resynchronization Therapy-Defibrillator (CRT-D) Device implanted patients
Overall Study Lost to Follow-up	7
Overall Study Protocol Violation	6
Overall Study Death	5
Overall Study Physician Decision	4
Overall Study Withdrawal by Subject	3
Overall Study Other reasons	14

Baseline Characteristics

AVAI: Atrial Ventricular Arrythmia Incidence

Baseline characteristics by cohort

Measure	St Jude Medical ICD/CRT-D n=157 Participants St Jude Medical ICD/CRT-D Device implanted patients
Age, Continuous	61.67 years STANDARD_DEVIATION 13.39 • n=5 Participants
Sex: Female, Male Female	35 Participants n=5 Participants
Sex: Female, Male Male	122 Participants n=5 Participants

PRIMARY outcome

Timeframe: 24 months

Population: 157 patients were analyzed: 118 completed 2 years of Follow Up (FU) and 39 patients were terminated before completing it

Slow Ventricular Tachycardia episodes will be considered as a tachycardia episodes detected by the device between 120-150 bpm and with more than 30sec of duration AF Episodes will be considered only when their duration is >30sec

Outcome measures

Measure	St Jude Medical ICD/CRT-D n=157 Participants St Jude Medical ICD/CRT-D Device implanted patients
Slow Ventricular Tachycardia Episodes Devices Detected (Between 120-150 Bpm and > 30sec) Atrial Fibrillation (AF) Episodes Devices Detected (> 30 Sec) Device Slow VT Episodes	3778 Episodes
Slow Ventricular Tachycardia Episodes Devices Detected (Between 120-150 Bpm and > 30sec) Atrial Fibrillation (AF) Episodes Devices Detected (> 30 Sec) Internal Investigator Slow VT Episodes	112 Episodes
Slow Ventricular Tachycardia Episodes Devices Detected (Between 120-150 Bpm and > 30sec) Atrial Fibrillation (AF) Episodes Devices Detected (> 30 Sec) External investigator Slow VT Episodes	68 Episodes
Slow Ventricular Tachycardia Episodes Devices Detected (Between 120-150 Bpm and > 30sec) Atrial Fibrillation (AF) Episodes Devices Detected (> 30 Sec) Device AF>30sec Episodes	308 Episodes
Slow Ventricular Tachycardia Episodes Devices Detected (Between 120-150 Bpm and > 30sec) Atrial Fibrillation (AF) Episodes Devices Detected (> 30 Sec) Internal Investigator AF>30sec Episodes	1900 Episodes
Slow Ventricular Tachycardia Episodes Devices Detected (Between 120-150 Bpm and > 30sec) Atrial Fibrillation (AF) Episodes Devices Detected (> 30 Sec) External Investigator AF>30sec Episodes	2864 Episodes

SECONDARY outcome

Timeframe: 24 months

Outcome measures

Measure	St Jude Medical ICD/CRT-D n=157 Participants St Jude Medical ICD/CRT-D Device implanted patients
Cardiovascular Mortality Hospitalization Rate Due to Cardiovascular Reasons or Heart Failure Cardiovascular Mortality	5 Patients
Cardiovascular Mortality Hospitalization Rate Due to Cardiovascular Reasons or Heart Failure Hospitalization due to cardiovascular reasons	31 Patients

Adverse Events

St Jude Medical ICD/CRT-D

Serious events: 67 serious events

Other events: 20 other events

Deaths: 0 deaths

Serious adverse events

Measure	St Jude Medical ICD/CRT-D n=157 participants at risk St Jude Medical ICD/CRT-D Device implanted patients
General disorders Serious AE	32.5% 51/157 • Number of events 88 • 2 years All Adverse Events (AE) in the study were classified as: * Serious AE * Serious Device Related AE * Unsuspected Serious Device Related AE * Non-Serious AE * Non-Serious Device Related AE There is not enough information available for a more detailed classification
Cardiac disorders Serious Device related AE	8.3% 13/157 • Number of events 14 • 2 years All Adverse Events (AE) in the study were classified as: * Serious AE * Serious Device Related AE * Unsuspected Serious Device Related AE * Non-Serious AE * Non-Serious Device Related AE There is not enough information available for a more detailed classification
Cardiac disorders Unspected Serious Device related AE	1.9% 3/157 • Number of events 3 • 2 years All Adverse Events (AE) in the study were classified as: * Serious AE * Serious Device Related AE * Unsuspected Serious Device Related AE * Non-Serious AE * Non-Serious Device Related AE There is not enough information available for a more detailed classification

Other adverse events

Measure	St Jude Medical ICD/CRT-D n=157 participants at risk St Jude Medical ICD/CRT-D Device implanted patients
General disorders AE	10.2% 16/157 • Number of events 19 • 2 years All Adverse Events (AE) in the study were classified as: * Serious AE * Serious Device Related AE * Unsuspected Serious Device Related AE * Non-Serious AE * Non-Serious Device Related AE There is not enough information available for a more detailed classification
General disorders Device related AE	2.5% 4/157 • Number of events 4 • 2 years All Adverse Events (AE) in the study were classified as: * Serious AE * Serious Device Related AE * Unsuspected Serious Device Related AE * Non-Serious AE * Non-Serious Device Related AE There is not enough information available for a more detailed classification

Additional Information

Dr Ignacio Fernández Lozano

Hospital Clínico Universitario Puerta de Hierro

Phone: 913445000

Email: iflozano@secardiologia.es

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place