Patients With an Indication for an ICD Implantation According to the GuidelinesProSANCT01714921

Protecta Smart Analysis Register

An observational study of Patients With an Indication for an ICD Implantation According to the Guidelines, run by Medtronic Cardiac Rhythm and Heart Failure.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Patients With an Indication for an ICD Implantation According to the Guidelines
How many people: 504 participants
Where: No sites listed yet
Study dates: 9 Jun 2010to 5 Jan 2015
How long will I take part?: 24 Months
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Study population: Patients that satisfy the inclusion criteria and signed the informed consent

Who may be able to join

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

Who cannot join

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

About this study

Official title: ProSA Protecta Smart Analysis Register

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

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT01714921
Study group	Role	What they receive
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 being measured

The primary outcome is the main question the study is designed to answer.

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™ 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 Charging
Measured: 24 months

Secondary outcomes (6)

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.
Measured: 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
Measured: 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
Measured: 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)
Measured: 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
Measured: 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'.
Measured: through study completion

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

9 Jun 20105 Jan 2015

First posted26 Oct 2012 (estimated)
Study start9 Jun 2010
Primary completion5 Jan 2015
Study completion5 Jan 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Patients With an Indication for an ICD Implantation According to the GuidelinesStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 504 participants (actual)
Target duration: 24 Months

IDs, dates and publications

ClinicalTrials.gov ID: NCT01714921
Sponsor's protocol ID: CEN_G_CA_13
Acronym: ProSA
Status last verified: Apr 2018
First submitted: 16 Oct 2012
Last updated: 2 Jul 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Study at a glance

From the registry record, last updated by the sponsor on 2 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: ProSA Protecta Smart Analysis Register
ClinicalTrials.gov ID: NCT01714921
Acronym / sponsor ID: ProSA / CEN_G_CA_13
Conditions: Patients With an Indication for an ICD Implantation According to the Guidelines
Study type: Observational
Recruitment status: Completed
Enrolment: 504 participants (actual)
Lead sponsor: Medtronic Cardiac Rhythm and Heart FailureIndustry (pharma, biotech, devices)
Collaborators: Medtronic GmbH Germany
Study start: 9 Jun 2010 (actual)
Primary completion: 5 Jan 2015 (actual)
Study completion: 5 Jan 2015 (actual)
First posted: 26 Oct 2012 (estimated)
Results: Posted 13 Nov 2018

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Observational model: Cohort
Time perspective: Prospective
Target follow-up: 24 Months
Number of arms: 1

Arm	Type	Receives
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

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Patients that satisfy the inclusion criteria and signed the informed consent

Key inclusion criteria (2 listed)

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

Key exclusion criteria (3 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Primary outcome

Analysis of Change of Episodes Inappropriately Treated by Shock Therapy Due to Smart Shock™ Technology.
Time frame: 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 Charging

6 secondary outcomes

Number of Patients With All Smart Shock Algorithms Are Programmed on
Time frame: 90 days or 180 days
Percentage of Patients, Without Shock Delivery Due to Smart Shock Technology
Time frame: 24 months
Analysis of the Number of Patients With Primary Preventive Indication for an ICD That Develop VF Episodes.
Time frame: 24 months
Number of Patients That Developed AT/AF
Time frame: 24 months
Analysis of the Proportion of Patients in Which ICD Parameters Remain on Nominal Programming.
Time frame: At the first Follow-Up ≥ 90 days post-implant
Analysis of the Positive Predictive Value of the Investigated ICD Oversensing Algorithms
Time frame: through study completion

Results and safety

Results posted to the registry on 13 Nov 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
ICD Patients (Single Arm Study)	504	311

Primary outcome: Analysis of Change of Episodes Inappropriately Treated by Shock Therapy Due to Smart Shock™ Technology.

Time frame: 24 months. Number. Unit: % of episodes wo shock due to SmartShock

Measure	ICD Patients (Single Arm Study) n = 504
Value	94.9

Population analysed: The change of episodes of episodes inappropriately treated by shock due to Smart Shock™ was calculated as follow: change of episodes= (Episodes without shock therapy due to Smart Shock™)/(total number of episodes)

6 secondary outcomes are reported in the full results.

Adverse events

Time frame: All devices that were used in this study are market-released and were only used within their approved indication. Therefore vigilance reporting was performed in the context of Post Market Surveillance. Adverse event information was therefore not collected during this study.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
ICD Patients (Single Arm Study)	0 of 0	0 of 0	Not reported

Limitations and caveats (from the sponsor): * No electronic case report form data available / only device data used * Appropriateness of classification of Smart Shock algorithms not established; i.e. episode classification was limited to secondary endpoint 6 * No source data verification

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

Questions about this trial

What is this clinical trial studying?

An observational study of Patients With an Indication for an ICD Implantation According to the Guidelines, run by Medtronic Cardiac Rhythm and Heart Failure.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 13 Nov 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Analysis of Change of Episodes Inappropriately Treated by Shock Therapy Due to Smart Shock™ Technology. (time frame: 24 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01714921.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2025.