NCT01714921: ProSA

Protecta Smart Analysis Register

Completed Results posted Last updated 2 July 2025

What this trial tests

trial in Patients With an Indication for an ICD Implantation According to the Guidelines in 504 participants. Completed in 5 January 2015.

Timeline

9 June 2010

Primary endpoint
5 January 2015

5 January 2015

Quick facts

Lead sponsor	Medtronic Cardiac Rhythm and Heart Failure
Status	Completed
Study type	OBSERVATIONAL
Enrollment	504
Start date	9 June 2010
Primary completion	5 January 2015
Estimated completion	5 January 2015

Conditions studied

• Patients With an Indication for an ICD Implantation According to the Guidelines — all drugs for Patients With an Indication for an ICD Implantation According to the Guidelines →

Sponsor

Medtronic Cardiac Rhythm and Heart Failure — full company profile →

Who can join

18 and older, any sex, with Patients With an Indication for an ICD Implantation According to the Guidelines. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Analysis of Change of Episodes Inappropriately Treated by Shock Therapy Due to Smart Shock™ Technology. Primary · 24 months

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™ technology * Episodes classified as supraventricular tachycardia (SVT) by PR Logic * Episodes classified as SVT by Wavelet * Shock therapy suppressed by T-wave Discrimination * Shock therapy suppressed by Lead Noise Discrimination * Shock therapy suppressed by Confirmation + * Episode with successful anti-tachycardia pacing (ATP) During Charg

Group	Value	95% CI
ICD Patients (Single Arm Study)	94.9

Number of Patients With All Smart Shock Algorithms Are Programmed on Secondary · 90 days or 180 days

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.

Group	Value	95% CI
ICD Patients (Single Arm Study)	300

Percentage of Patients, Without Shock Delivery Due to Smart Shock Technology Secondary · 24 months

Endpoint: Patients without shock delivery due to Smart Shock technology

Group	Value	95% CI
ICD Patients (Single Arm Study)	15.3

Analysis of the Number of Patients With Primary Preventive Indication for an ICD That Develop VF Episodes. Secondary · 24 months

Endpoint: Number of primary prevention patients with at least one ventricular fibrillation (VF) episode detected and successfully treated by the ICD

Group	Value	95% CI
ICD Patients	15

Number of Patients That Developed AT/AF Secondary · 24 months

Endpoint: patients with \>5 min atrial tachycardia/atrial fibrillation (AT/AF) in 'Daily Log' (Cardiac Compass)

Group	Value	95% CI
ICD Patients (Single Arm Study)	117

Analysis of the Proportion of Patients in Which ICD Parameters Remain on Nominal Programming. Secondary · At the first Follow-Up ≥ 90 days post-implant

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 Over

Group	Value	95% CI
ICD Patients (Single Arm Study)	421

Analysis of the Positive Predictive Value of the Investigated ICD Oversensing Algorithms Secondary · through study completion

Endpoint: Episode classified by the device as T-wave Oversensing or 'Noise'.

Group	Value	95% CI
ICD Patients (Single Arm Study)	100

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.