Stanford Cardiac Invasive Electrophysiology Novel Computer Experience

Atrial Fibrillation Clinical Trial

— SCIENCE  

Official title:

Stanford Cardiac Invasive Electrophysiology Novel Computer Experience (SCIENCE)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03549806
• Other study ID #: SCIENCE
• Status: Completed
• Start date: June 21, 2018
• Est. completion date: January 11, 2021

Study information

• Verified date: May 2021
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This study will test the ability of computer algorithms to predict successful ablation therapy for atrial arrhythmias.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11
• Est. completion date: January 11, 2021
• Est. primary completion date: November 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 80 Years

Eligibility

Inclusion Criteria:

• Patients undergoing catheter ablation for atrial arrhythmias

Exclusion Criteria:

• Inability to sign informed consent
• Expected survival < 1 year
• Extreme comorbidity, such as advanced NYHA Class III/IV heart failure, dialysis, series stroke.

Related Conditions & MeSH terms

• Arrhythmias, Cardiac
• Atrial Fibrillation
• Atrial Flutter
• Atrial Tachycardia
• Tachycardia

Intervention

Diagnostic Test:
• 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

Locations

Country	Name	City	State
United States	Stanford Hospital	Stanford	California

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

References & Publications (4)

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 Electr — View Citation

Navara 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 — View Citation

Sahli 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. — View Citation

Zaman 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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Acute Impact of Ablation	Documentation of whether ablation acutely eliminated atrial fibrillation	Day zero (that is, during procedure).
Primary	Reduction in AF burden on follow-up	Reduction in amount of arrhythmia per unit time, compared to prior to the procedure.	2 years
Primary	Freedom from arrhythmia on follow-up	Absence of arrhythmia, defined by clinical thresholds.	2 years
Secondary	Clinical status as measured by the EQ5D	Patient feeling better subjectively in EQ5D	2 years