Data CollectionPSOTNCT03858361

Patient Specific Optimized Therapy (PSOT)

An observational study of Data Collection, run by EPD Solutions, A Philips Company at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Trial summary

Data collection from atrial flutter patients before, during and after undergoing catheter-based electrophysiological (EP) intervention in order to develop a patient specific optimized therapy (PSOT) to improve specific patient's arrhythmia treatment for Atrial Flutter. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Data Collection
What is being tested?: Atrial Flutter Ablation
Type of treatment: Medical device
How many people: 566 participants
Where: 1 siteUnited States
Study dates: 13 Sep 2019to 28 Mar 2023
How long will I take part?: 3 Months
Phase: Observational
Are there results?: None posted in the registry

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: Arrhythmia patients with Atrial Flutter indicated for EP procedures.

Who may be able to join

Subject is at least 18 years of age.
Subject signed a written Informed Consent form to participate in the study, prior to any study related procedures.
Subject is willing to comply with the protocol requirements and return to the treatment center for all required clinical evaluations.
A female subject is eligible if not of child bearing potential or has a negative pregnancy test within the previous 7 days.
Subject is deemed amenable to therapeutic ablation for atrial flutter.

Who cannot join

Any planned surgical or endovascular intervention within 30 days before or after the index procedure.
Subject is enrolled in another drug or device study protocol that has not reached its primary endpoint.
Patient had experienced previous stroke (TIA or CVA).
Thrombi detected in the heart.
Known marked valvar insufficiency.
Life expectancy less than 12 months.
Known severe renal insufficiency.

Trial locations and contacts

1 site in 1 country.

United States1 site

Baptist Health South Florida
Florida City, Florida, 33143

Other trials in United States

About this study

Official title: Patient Specific Optimized Therapy (PSOT) in Atrial Flutter Population Miami Cardiac & Vascular Institute (MCVI) Post Marketing Surveillance (PMS) Study

Read the detailed description

Prospective, single-center, non-randomized, open label, single arm study. Consented subjects who are scheduled to undergo ablation due to atrial flutter will be enrolled in the study. Data will be collected from all subjects during the ablation procedure and post procedure for a period of 3 months.

KODEX - EPD™ system will be used in all procedures during treatment of cardiac arrhythmias.

Anonymized data will be stored in an EPD database and will be used to train and test predictors for personalized optimized therapy.

Data will be collected on paper and/or electronic forms and saved in the EPD Database.

Advanced data analysis will be used to map patient specific demographics, history, current ailment, intervention to patient outcome. The technology to be utilized will help develop a method to identify the personalized treatment for a given patient (defined by: patient's demographic, history, current ailment and intervention information to achieve optimal outcome).

Data will be anonymized by removing patient protected health information, only initials will be used. The data will be integrated to an EPD data base and will be used to train and test predictors for personalized optimized therapy.

Conditions: Data Collection
Being tested: Atrial Flutter Ablation

What participants receive

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

Atrial Flutter AblationDevice
Catheter-based electrophysiological (EP) intervention.

What is being measured

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

Arrhythmia recurrence The number of Arrhythmia recurrence
The number of arrhythmia recurrence
Measured: 3 months

Timeline

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

13 Sep 201928 Mar 2023

First posted28 Feb 2019
Study start13 Sep 2019
Primary completion28 Mar 2023
Study completion28 Mar 2023

Why it stopped: Philips decided to wind down the EPD Solution business

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Data CollectionStudies 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: 566 participants (actual)
Target duration: 3 Months

IDs, dates and publications

ClinicalTrials.gov ID: NCT03858361
Sponsor's protocol ID: CLN-KODEX-0011
Acronym: PSOT
Status last verified: Jun 2023
First submitted: 20 Feb 2019
Last updated: 8 Jun 2023
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: Undecided

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 8 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Patient Specific Optimized Therapy (PSOT) in Atrial Flutter Population Miami Cardiac & Vascular Institute (MCVI) Post Marketing Surveillance (PMS) Study
ClinicalTrials.gov ID: NCT03858361
Acronym / sponsor ID: PSOT / CLN-KODEX-0011
Conditions: Data Collection
Study type: Observational
Recruitment status: TerminatedReason stopped: Philips decided to wind down the EPD Solution business
Enrolment: 566 participants (actual)
Lead sponsor: EPD Solutions, A Philips CompanyIndustry (pharma, biotech, devices)
Study start: 13 Sep 2019 (actual)
Primary completion: 28 Mar 2023 (actual)
Study completion: 28 Mar 2023 (actual)
First posted: 28 Feb 2019 (actual)
Results: Not posted in the source record

Clinical summary

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

Detailed description

KODEX - EPD™ system will be used in all procedures during treatment of cardiac arrhythmias.

Anonymized data will be stored in an EPD database and will be used to train and test predictors for personalized optimized therapy.

Data will be collected on paper and/or electronic forms and saved in the EPD Database.

Study design

Observational model: Cohort
Time perspective: Prospective
Target follow-up: 3 Months

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Arrhythmia patients with Atrial Flutter indicated for EP procedures.

Key inclusion criteria (5 listed)

Subject is at least 18 years of age.
Subject signed a written Informed Consent form to participate in the study, prior to any study related procedures.
Subject is willing to comply with the protocol requirements and return to the treatment center for all required clinical evaluations.
A female subject is eligible if not of child bearing potential or has a negative pregnancy test within the previous 7 days.
Subject is deemed amenable to therapeutic ablation for atrial flutter.

Key exclusion criteria (7 listed)

Any planned surgical or endovascular intervention within 30 days before or after the index procedure.
Subject is enrolled in another drug or device study protocol that has not reached its primary endpoint.
Patient had experienced previous stroke (TIA or CVA).
Thrombi detected in the heart.
Known marked valvar insufficiency.

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

Interventions

Intervention	Type	Arms
Atrial Flutter AblationCatheter-based electrophysiological (EP) intervention.	Device	–

Primary outcome

Arrhythmia recurrence The number of Arrhythmia recurrence
Time frame: 3 months
The number of arrhythmia recurrence

Results and safety

The study was stopped early (reason given: Philips decided to wind down the EPD Solution business). Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2023.
Individual participant dataSharing planned: Undecided

Related trials for Data Collection

Active, not recruitingObservational study
FARAPULSE™ Pulsed Field Ablation System
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RecruitingObservational study
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Chordoma
RecruitingObservational study
Collecting Information About Treatment Results for Patients With Cushing's Syndrome
Cushing's Disease, Cushing Syndrome
Not yet recruitingObservational study
Real-World Data Collection of GORE Devices Used In the Endovascular Treatment of Aortic Aneurysms Which Incorporate Visceral Arteries.
Complex Aortic Aneurysms, Thoracoabdominal Aneurysm
RecruitingObservational study
Study of Collection and Analysis of Clinical, Anamnestic, Functional, Biological Data Through the Support of Artificial Intelligence to Evaluate the Possibility of Defining a Digital Twin of the Lung (LUCE)
Thoracic Neoplasm, Pulmonary Nodules

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.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Data Collection, run by EPD Solutions, A Philips Company at 1 site in United States.

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 5 inclusion and 7 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: stopped early, as of the sponsor's last update on 8 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

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?

The study was stopped early (reason given: Philips decided to wind down the EPD Solution business). Results are not available in the source record.

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?

Arrhythmia recurrence The number of Arrhythmia recurrence (time frame: 3 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 NCT03858361.

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 8 Jun 2023.