Efficacy of the ATP Switch Automatic Programming in NCT01169246

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Clinical Trial Details — Status: Terminated

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

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

Recruitment information / eligibility
Status	Terminated
Enrollment	1254
Est. completion date	February 2015
Est. primary completion date	February 2015
Accepts healthy volunteers	No
Gender	All
Age group	18 Years and older
Eligibility	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

Locations
Country	Name	City	State
France	CHU Brest	Brest

Sponsors *(2)*
Lead Sponsor	Collaborator
MicroPort CRM	Sorin Group France SAS

France,

Outcome
Type	Measure	Description	Time frame	Safety issue
Primary	Ventricular Tachyarrhythmia episode	% of VT episode successfully reduced by the ATP Auto-switch	2 years
Secondary	Arrhythmia incidence	DEvice based data	2 years

See also
Status	Clinical Trial	Phase
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Completed	`NCT00765713` - Sleep Apnea-hypopnea Syndrome (SAHS) and Ventricular Arrhythmias	Phase 4
Active, not recruiting	`NCT00288756` - The V-Tachogram:Decreasing Ventricular Arrythmias When Injecting Contrast in the Left Ventricle	Phase 1
Withdrawn	`NCT00882622` - Effect of Remote Ischemic Preconditioning on Cardiac Function After Cardiac Surgery	Phase 1
Completed	`NCT00746356` - Safety and Efficacy of Automatic Testing Feature in New ICDs and CRT-Ds	N/A