Atrial FibrillationNCT04127123
Cloud-Based Mapping for Personalized Ablation
An observational study of Atrial Fibrillation and Arrhythmias, Cardiac, run by Stanford University at 1 site in United States.
Trial summary
Atrial fibrillation is a serious public health issue that affects over 5 million Americans in whom it may cause skipped beats, dizziness, stroke and even death. This study seeks to improve our understanding of the causes of atrial fibrillation and to design new and more effective therapy for this heart rhythm disorder. Read more about this study
- Who is it for?
- Ages 21 to 80 years
- Conditions the study is for
- Atrial Fibrillation, Arrhythmias, Cardiac
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Jul 2019to 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: Subjects will be men and women of any ethnicity aged 21-80 years undergoing ablation at Stanford of AF. Patients will have failed or be intolerant of ≥ 1 anti-arrhythmic drug or not willing to accept antiarrhythmic drug therapy. 50 patients will be enrolled at Stanford University over 1-2 years.
Who may be able to join
- men and women of any ethnicity
- aged 21-80 years
- undergoing ablation of atrial fibrillation at Stanford University
- failed or be intolerant of ≥ 1 anti-arrhythmic drug or not willing to accept antiarrhythmic drug therapy.
Who cannot join
- active coronary ischemia or decompensated heart failure
- atrial or ventricular clot on trans-esophageal echocardiography
- pregnancy (to minimize fluoroscopic exposure)
- inability or unwillingness to provide informed consent
- rheumatic valve disease (because it results in a unique AF phenotype)
- thrombotic disease or venous filters
- significantly reduced kidney function
Trial locations and contacts
1 site in 1 country.
About this study
Atrial fibrillation is a serious public health issue that affects over 5 million Americans in whom it may cause skipped beats, dizziness, stroke and even death. This study seeks to improve our understanding of the causes of atrial fibrillation and to design new and more effective therapy for this heart rhythm disorder.
Read the detailed description
This project will focus on the development of a novel paradigm for electrophysiologic data analysis and interpretation using cloud-based computing resources and mobile technology. Currently, electrophysiologic data gathered during a procedure is analyzed by the operator using multiple separate desk-based computer systems in the electrophysiology laboratory. The investigators propose that advances in cloud-based computing resources and network connectivity should apply a mobile paradigm to apply to invasive electrophysiologic procedures.
This project will provide proof-of-concept that open-access software the investigators have developed and made available online could be used, via a mobile phone interface, to identify sites in the heart where therapy is effective. At no time will patient therapy be guided by this system. The investigators will pursue therapy using only clinical means. In parallel, a double-blinded team will analyze data in real time using our online software visualized on a smartphone. Only when the case is concluded will the data be unblinded, to determine if the mobile system was accurate in real time.
Thus, development and testing of the cloud-based computing system is designed only to establish feasibility of the paradigm, followed by improvement of computational modeling algorithms. The data that is collected will add to the investigators' existing unique catalogue of multimodal (structural, clinical, and electrophysiologic) data.
The importance of this novel paradigm is to move from analyzing large volumes of data in isolation to creating a mobile platform, and to allow scalability to increase access, such as to underdeveloped medical centers.
- Conditions
- Atrial Fibrillation, Arrhythmias, Cardiac
- Keywords
- arrhythmia, cardiac electrophysiology, ablation
- Medical subject headings
- Atrial Fibrillation, Arrhythmias, Cardiac
What is being measured
The primary outcome is the main question the study is designed to answer.
Mapping Accuracy
Location of driver regions for AF
Measured: During Procedure (Electrophysiology Study and Ablation)
Termination of atrial fibrillation
Does ablation at any driver region lead to AF termination
Measured: During Procedure (Electrophysiology Study and Ablation)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2019
- Study start3 Jul 2019
- Primary completion30 Dec 2020
- Study completion11 Jan 2021
Why it stopped: Difficulty enrolling due to COVID closures
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 0 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
- NCT04127123
- Sponsor's protocol ID
- 49800
- Other IDs
- 49800
- Status last verified
- May 2021
- First submitted
- 1 Apr 2019
- Last updated
- 7 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cloud-Based Mapping for Personalized Ablation
- ClinicalTrials.gov ID
- NCT04127123
- Acronym / sponsor ID
- 49800
- Conditions
- Atrial Fibrillation, Arrhythmias, Cardiac
- Keywords
- arrhythmia, cardiac electrophysiology, ablation
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Difficulty enrolling due to COVID closures
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- 3 Jul 2019 (actual)
- Primary completion
- 30 Dec 2020 (actual)
- Study completion
- 11 Jan 2021 (actual)
- First posted
- 15 Oct 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.
Atrial fibrillation is a serious public health issue that affects over 5 million Americans in whom it may cause skipped beats, dizziness, stroke and even death. This study seeks to improve our understanding of the causes of atrial fibrillation and to design new and more effective therapy for this heart rhythm disorder.
Detailed description
This project will focus on the development of a novel paradigm for electrophysiologic data analysis and interpretation using cloud-based computing resources and mobile technology. Currently, electrophysiologic data gathered during a procedure is analyzed by the operator using multiple separate desk-based computer systems in the electrophysiology laboratory. The investigators propose that advances in cloud-based computing resources and network connectivity should apply a mobile paradigm to apply to invasive electrophysiologic procedures.
This project will provide proof-of-concept that open-access software the investigators have developed and made available online could be used, via a mobile phone interface, to identify sites in the heart where therapy is effective. At no time will patient therapy be guided by this system. The investigators will pursue therapy using only clinical means. In parallel, a double-blinded team will analyze data in real time using our online software visualized on a smartphone. Only when the case is concluded will the data be unblinded, to determine if the mobile system was accurate in real time.
Thus, development and testing of the cloud-based computing system is designed only to establish feasibility of the paradigm, followed by improvement of computational modeling algorithms. The data that is collected will add to the investigators' existing unique catalogue of multimodal (structural, clinical, and electrophysiologic) data.
The importance of this novel paradigm is to move from analyzing large volumes of data in isolation to creating a mobile platform, and to allow scalability to increase access, such as to underdeveloped medical centers.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 21 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects will be men and women of any ethnicity aged 21-80 years undergoing ablation at Stanford of AF. Patients will have failed or be intolerant of ≥ 1 anti-arrhythmic drug or not willing to accept antiarrhythmic drug therapy. 50 patients will be enrolled at Stanford University over 1-2 years.
Key inclusion criteria (4 listed)
- men and women of any ethnicity
- aged 21-80 years
- undergoing ablation of atrial fibrillation at Stanford University
- failed or be intolerant of ≥ 1 anti-arrhythmic drug or not willing to accept antiarrhythmic drug therapy.
Key exclusion criteria (7 listed)
- active coronary ischemia or decompensated heart failure
- atrial or ventricular clot on trans-esophageal echocardiography
- pregnancy (to minimize fluoroscopic exposure)
- inability or unwillingness to provide informed consent
- rheumatic valve disease (because it results in a unique AF phenotype)
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
Mapping Accuracy
Time frame: During Procedure (Electrophysiology Study and Ablation)
Location of driver regions for AF
Termination of atrial fibrillation
Time frame: During Procedure (Electrophysiology Study and Ablation)
Does ablation at any driver region lead to AF termination
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2021.
Related trials for Atrial Fibrillation
RecruitingObservational study
Atrial Fibrillation Patients Treated With Catheter Ablation
Atrial Fibrillation, Atrial Fibrillation Recurrent
Not yet recruiting
A Study to Predict Atrial Fibrillation (AF) Burden in Participants With PAF and PsAF Treated With the VARIPULSE™ PFA Catheter
Atrial Fibrillation
Recruiting
Anatomical Navigation for Guided Electrophysiology in AFL and AFib
Atrial Fibrillation, Atrial Flutter
Not yet recruiting
Paroxysmal Atrial Fibrillation Repeat Ablation Strategies With Durably Isolated Pulmonary Veins
Ablation Techniques, Atrial Fibrillation (Paroxysmal)
Recruiting
A Study of VARIPULSE Catheter in Participants With Persistent Atrial Fibrillation Undergoing Pulmonary Vein and Superior Vena Cava Isolation
Atrial Fibrillation
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 Arrhythmias, Cardiac, 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 4 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: withdrawn, as of the sponsor's last update on 7 May 2021. 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 withdrawn before enrolling participants, so there are no results.
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?
Mapping Accuracy (time frame: During Procedure (Electrophysiology Study and Ablation)). 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?
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 7 May 2021.