Efficacy of the ATP Switch Automatic Programming in Implantable Cardioverter Defibrillator (ICD) and Cardiac Resynchronization Therapy Defibrillator (CRT-D) Implanted Patients

Efficacy of the ATP Switch Automatic Programming in ICD and CRT-D Implanted Patients

Status

Terminated

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01169246

Acronym

ASAP

Enrollment

1254

Registered

2010-07-26

Start date

2009-11-30

Completion date

2015-02-28

Last updated

2019-03-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ventricular Arrythmias

Keywords

ATP,CRT, ICD PARADYM

Brief summary

Primary objective is to assess the efficacy of the new ATP Autoswitch function in simple, dual or triple chamber ICD.

Detailed description

The efficacy rate of the ATP Auto-switch function, defined as the % of VT episodes successfully reduced, will be compared with 85%.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* The patient has been implanted (primo implantation or replacement) with an ICD model PARADYM VR 8250, DR 8550, CRT 8750, CRT 8770 models or any similar or higher range device * ATP Auto-switch function is programmed ON

Exclusion criteria

* Presence of a contra-indication to the ICD therapy * Life expectancy less than 12 months

Design outcomes

Primary

Measure	Time frame	Description
Ventricular Tachyarrhythmia episode	2 years	% of VT episode successfully reduced by the ATP Auto-switch

Secondary

Measure	Time frame	Description
Arrhythmia incidence	2 years	DEvice based data

Countries

France

Outcome results