Protecta Smart Analysis Register (ProSA)

ProSA Protecta Smart Analysis Register

ProSA is a prospective, non-randomized, multicenter, observational study investigating the utilization and effectiveness of the Smart Shock™ algorithm in ICD patients treated with a Protecta™, Protecta™ XT or any equivalent following product.

Study Overview

• Status: Completed
• Conditions: Patients With an Indication for an ICD Implantation According to the Guidelines

• Study Type: Observational
• Enrollment (Actual): 504

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients that satisfy the inclusion criteria and signed the informed consent

Description

Inclusion Criteria:

• patients implanted with an Implantable Cardioverter Defibrillator (ICD) with the smart shock algorithm (Protecta™, Protecta™ XT or any equivalent following product)
• written informed consent

Exclusion Criteria:

• patients with life expectancy less than 24 months
• patients younger than 18 years
• pregnant or breast feeding women

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
ICD patients; Patients with an indication for an ICD implantation according to the guidelines treated with a Protecta™, Protecta™ XT or any equivalent following product

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Analysis of Change of Episodes Inappropriately Treated by Shock Therapy Due to Smart Shock™ Technology.	Smart Shock technology is a suite of algorithms that are designed to prevent inappropriate shocks in ICD&CRT patients. Endpoints for the primary objective: Episodes with shock therapy; Episodes without shock delivery due to Smart Shock™ technologyEpisodes classified as supraventricular tachycardia (SVT) by PR LogicEpisodes classified as SVT by WaveletShock therapy suppressed by T-wave DiscriminationShock therapy suppressed by Lead Noise DiscriminationShock therapy suppressed by Confirmation +Episode with successful anti-tachycardia pacing (ATP) During Charging	24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Patients With All Smart Shock Algorithms Are Programmed on	Endpoint: Patients, in which none of the Smart Shock algorithms is programmed "OFF" during the first Follow-Up after a maximum length of 90 days and 180 days.	90 days or 180 days
Percentage of Patients, Without Shock Delivery Due to Smart Shock Technology	Endpoint: Patients without shock delivery due to Smart Shock technology	24 months
Analysis of the Number of Patients With Primary Preventive Indication for an ICD That Develop VF Episodes.	Endpoint: Number of primary prevention patients with at least one ventricular fibrillation (VF) episode detected and successfully treated by the ICD	24 months
Number of Patients That Developed AT/AF	Endpoint: patients with >5 min atrial tachycardia/atrial fibrillation (AT/AF) in 'Daily Log' (Cardiac Compass)	24 months
Analysis of the Proportion of Patients in Which ICD Parameters Remain on Nominal Programming.	Endpoint: Deviation of ICD parameter programming in comparison to nominal programming at the first Follow-Up ≥ 90 days post-implant. Nominals for dual chamber ICD or cardiac resynchronization therapy (CRT) devices: Lead Noise Discrimination = 'OnWithTimeout'; Lead Failure Predictor = 'On'; PR-Logic: AfibAflutter Rejection Rule = 'On'; PR-Logic: Sinus Tach Rejection Rule = 'On'; PR-Logic: Other 1:1 Rejection Rule = 'On'; High Rate Timeout = 'Off'; VF High Rate Timeout = 'Off'; Wavelet Rejection Rule = 'On'; VF Detection Interval = 320 and SVT Minimum Cycle Length = 260; T-Wave Oversensing Discrimination = 'On'; ATP During Charging = 'DuringCharging' Nominals for single chamber ICDs: Lead Noise Discrimination = 'OnWithTimeout'; Lead Failure Predictor = 'On'; High Rate Timeout = 'Off'; VF High Rate Timeout = '0.75 min'; Wavelet Rejection Rule = 'On'; VF Detection Interval = 320 and SVT Minimum Cycle Length = 260; T-Wave Oversensing D	At the first Follow-Up ≥ 90 days post-implant
Analysis of the Positive Predictive Value of the Investigated ICD Oversensing Algorithms	Endpoint: Episode classified by the device as T-wave Oversensing or 'Noise'.	through study completion

Collaborators and Investigators

• Sponsor: Medtronic Bakken Research Center
• Collaborators: Medtronic GmbH Germany

Study record dates

Study Major Dates

• Study Start (Actual): June 9, 2010
• Primary Completion (Actual): January 5, 2015
• Study Completion (Actual): January 5, 2015

Study Registration Dates

• First Submitted: October 16, 2012
• First Submitted That Met QC Criteria: October 23, 2012
• First Posted (Estimate): October 26, 2012

Study Record Updates

• Last Update Posted (Actual): November 13, 2018
• Last Update Submitted That Met QC Criteria: April 17, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: CEN_G_CA_13