Atrial FibrillationSCIENCENCT03549806
Stanford Cardiac Invasive Electrophysiology Novel Computer Experience
An observational study of Atrial Fibrillation and Atrial Tachycardia, run by Stanford University at 1 site in United States.
Trial summary
This study will test the ability of computer algorithms to predict successful ablation therapy for atrial arrhythmias. Read more about this study
- Who is it for?
- Ages 21 to 80 years
- Conditions the study is for
- Atrial Fibrillation, Atrial Tachycardia, Atrial Flutter
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Jun 2018to 11 Jan 2021
- 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 21 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients undergoing clinically prescribed ablation for complex atrial arrhythmias will be approached for enrollment. Most are anticipated to be atrial fibrillation or atrial tachyarrhythmias such as post-ablation flutter. Men and women over 21 years and up to 80 years of age will be included.
Who may be able to join
- Patients undergoing catheter ablation for atrial arrhythmias
Who cannot join
- Inability to sign informed consent
- Expected survival < 1 year
- Extreme comorbidity, such as advanced NYHA Class III/IV heart failure, dialysis, series stroke.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Stanford Cardiac Invasive Electrophysiology Novel Computer Experience (SCIENCE)
This study will test the ability of computer algorithms to predict successful ablation therapy for atrial arrhythmias.
Read the detailed description
Patients will be recruited prospectively from among those undergoing ablation for atrial fibrillation (AF) or atrial tachycardias (AT) which may be reentrant or focal. Each patient will undergo careful data collection, including electrogram data and sites of ablation lesions. Ablation will proceed in operator-dependent fashion, and will not be modified in any way for this study. The research question is whether algorithms based on data such as electrograms and details of the ablation performed can predict which patients will have a successful case. Primary endpoints are measures of clinical success defined by (a) acute termination of atrial arrhythmia during the case; (b) long-term reduction in arrhythmia burden; (c) long-term freedom from arrhythmia. Secondary endpoints include (a) identification of sites of arrhythmia termination; (b) improved clinical status.
- Being tested
- No Intervention. Test is computer algorithm.
- Keywords
- Atrium, tachyarrhythmias
- Medical subject headings
- Atrial Fibrillation, Atrial Flutter, Arrhythmias, Cardiac, Tachycardia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No Intervention. Test is computer algorithm.Diagnostic test
Diagnostic algorithms (test) will be run on already acquired clinical data. No study intervention in operator-prescribed clinical ablation. Predictive accuracy of test for study outcome will then be determined in follow-up
| Study group | Role | What they receive |
|---|---|---|
| Prospective Cohort | No study intervention. Patients referred for ablation of atrial arrhythmias will be treated as per operator preference with no study intervention. Data will be collected in de-identified fashion. Receives: Diagnostic Test: No Intervention. Test is computer algorithm. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in AF burden on follow-up
Reduction in amount of arrhythmia per unit time, compared to prior to the procedure.
Measured: 2 years
Freedom from arrhythmia on follow-up
Absence of arrhythmia, defined by clinical thresholds.
Measured: 2 years
Secondary outcomes (1)
Clinical status as measured by the EQ5D
Patient feeling better subjectively in EQ5D
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2018
- Study start21 Jun 2018
- Primary completion11 Jan 2021
- Study completion11 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- 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
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sanjiv Narayan, MD, PhD, Stanford University
- Investigators
- Sanjiv Narayan, MD, PhD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03549806
- Sponsor's protocol ID
- SCIENCE
- Acronym
- SCIENCE
- Status last verified
- Nov 2024
- First submitted
- 25 Apr 2018
- Last updated
- 2 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Alhusseini M, Vidmar D, Meckler GL, Kowalewski CA, Shenasa F, Wang PJ, Narayan SM, Rappel WJ. Two Independent Mapping Techniques Identify Rotational Activity Patterns at Sites of Local Termination During Persistent Atrial Fibrillation. J Cardiovasc Electrophysiol. 2017 Jun;28(6):615-622. doi: 10.1111/jce.13177. Epub 2017 Mar 20.
PubMed 28185348Zaman JAB, Sauer WH, Alhusseini MI, Baykaner T, Borne RT, Kowalewski CAB, Busch S, Zei PC, Park S, Viswanathan MN, Wang PJ, Brachmann J, Krummen DE, Miller JM, Rappel WJ, Narayan SM, Peters NS. Identification and Characterization of Sites Where Persistent Atrial Fibrillation Is Terminated by Localized Ablation. Circ Arrhythm Electrophysiol. 2018 Jan;11(1):e005258. doi: 10.1161/CIRCEP.117.005258.
PubMed 29330332Sahli Costabal F, Zaman JAB, Kuhl E, Narayan SM. Interpreting Activation Mapping of Atrial Fibrillation: A Hybrid Computational/Physiological Study. Ann Biomed Eng. 2018 Feb;46(2):257-269. doi: 10.1007/s10439-017-1969-3. Epub 2017 Dec 6.
PubMed 29214421Navara R, Leef G, Shenasa F, Kowalewski C, Rogers AJ, Meckler G, Zaman JAB, Baykaner T, Park S, Turakhia MP, Zei P, Viswanathan M, Wang PJ, Narayan SM. Independent mapping methods reveal rotational activation near pulmonary veins where atrial fibrillation terminates before pulmonary vein isolation. J Cardiovasc Electrophysiol. 2018 May;29(5):687-695. doi: 10.1111/jce.13446. Epub 2018 Feb 22.
PubMed 29377478
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stanford Cardiac Invasive Electrophysiology Novel Computer Experience (SCIENCE)
- ClinicalTrials.gov ID
- NCT03549806
- Acronym / sponsor ID
- SCIENCE / SCIENCE
- Keywords
- Atrium, tachyarrhythmias
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- 21 Jun 2018 (actual)
- Primary completion
- 11 Jan 2021 (actual)
- Study completion
- 11 Jan 2021 (actual)
- First posted
- 8 Jun 2018 (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.
This study will test the ability of computer algorithms to predict successful ablation therapy for atrial arrhythmias.
Detailed description
Patients will be recruited prospectively from among those undergoing ablation for atrial fibrillation (AF) or atrial tachycardias (AT) which may be reentrant or focal. Each patient will undergo careful data collection, including electrogram data and sites of ablation lesions. Ablation will proceed in operator-dependent fashion, and will not be modified in any way for this study. The research question is whether algorithms based on data such as electrograms and details of the ablation performed can predict which patients will have a successful case. Primary endpoints are measures of clinical success defined by (a) acute termination of atrial arrhythmia during the case; (b) long-term reduction in arrhythmia burden; (c) long-term freedom from arrhythmia. Secondary endpoints include (a) identification of sites of arrhythmia termination; (b) improved clinical status.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Prospective Cohort | – | Diagnostic Test: No Intervention. Test is computer algorithm.No study intervention. Patients referred for ablation of atrial arrhythmias will be treated as per operator preference with no study intervention. Data will be collected in de-identified fashion. |
Who may qualify
- Ages
- 21 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing clinically prescribed ablation for complex atrial arrhythmias will be approached for enrollment. Most are anticipated to be atrial fibrillation or atrial tachyarrhythmias such as post-ablation flutter. Men and women over 21 years and up to 80 years of age will be included.
Key inclusion criteria (1 listed)
- Patients undergoing catheter ablation for atrial arrhythmias
Key exclusion criteria (3 listed)
- Inability to sign informed consent
- Expected survival < 1 year
- Extreme comorbidity, such as advanced NYHA Class III/IV heart failure, dialysis, series stroke.
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 |
|---|---|---|
| No Intervention. Test is computer algorithm.Diagnostic algorithms (test) will be run on already acquired clinical data. No study intervention in operator-prescribed clinical ablation. Predictive accuracy of test for study outcome will then be determined in follow-up | Diagnostic test | Prospective Cohort |
Primary outcome
Reduction in AF burden on follow-up
Time frame: 2 years
Reduction in amount of arrhythmia per unit time, compared to prior to the procedure.
Freedom from arrhythmia on follow-up
Time frame: 2 years
Absence of arrhythmia, defined by clinical thresholds.
1 secondary outcome
Clinical status as measured by the EQ5D
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2024.
- Results publication: PubMed 28185348Alhusseini M, Vidmar D, Meckler GL, Kowalewski CA, Shenasa F, Wang PJ, Narayan SM, Rappel WJ. Two Independent Mapping Techniques Identify Rotational Activity Patterns at Sites of Local Termination During Persistent Atrial Fibrillation. J Cardiovasc Electrophysiol. 2017 Jun;28(6):615-622. doi: 10.1111/jce.13177. Epub 2017 Mar 20.
- Results publication: PubMed 29330332Zaman JAB, Sauer WH, Alhusseini MI, Baykaner T, Borne RT, Kowalewski CAB, Busch S, Zei PC, Park S, Viswanathan MN, Wang PJ, Brachmann J, Krummen DE, Miller JM, Rappel WJ, Narayan SM, Peters NS. Identification and Characterization of Sites Where Persistent Atrial Fibrillation Is Terminated by Localized Ablation. Circ Arrhythm Electrophysiol. 2018 Jan;11(1):e005258. doi: 10.1161/CIRCEP.117.005258.
- Results publication: PubMed 29214421Sahli Costabal F, Zaman JAB, Kuhl E, Narayan SM. Interpreting Activation Mapping of Atrial Fibrillation: A Hybrid Computational/Physiological Study. Ann Biomed Eng. 2018 Feb;46(2):257-269. doi: 10.1007/s10439-017-1969-3. Epub 2017 Dec 6.
- Results publication: PubMed 29377478Navara R, Leef G, Shenasa F, Kowalewski C, Rogers AJ, Meckler G, Zaman JAB, Baykaner T, Park S, Turakhia MP, Zei P, Viswanathan M, Wang PJ, Narayan SM. Independent mapping methods reveal rotational activation near pulmonary veins where atrial fibrillation terminates before pulmonary vein isolation. J Cardiovasc Electrophysiol. 2018 May;29(5):687-695. doi: 10.1111/jce.13446. Epub 2018 Feb 22.
- Individual participant dataSharing planned: Undecided
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Atrial Fibrillation (AF)
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.
Sanjiv Narayan, MD, PhD principal investigator
Stanford University
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 Atrial Fibrillation and Atrial Tachycardia, run by Stanford University 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 1 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 Dec 2024. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Reduction in AF burden on follow-up (time frame: 2 years). The study lists 2 primary outcomes in all. 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 NCT03549806, which also lists 4 linked publications.
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 Dec 2024.