NCT03549806

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
11

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jun 2018

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 25, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

June 8, 2018

Completed
13 days until next milestone

Study Start

First participant enrolled

June 21, 2018

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 11, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 11, 2021

Completed
Last Updated

December 2, 2024

Status Verified

November 1, 2024

Enrollment Period

2.6 years

First QC Date

April 25, 2018

Last Update Submit

November 26, 2024

Conditions

Atrial FibrillationAtrial TachycardiaAtrial FlutterArrhythmias, Cardiac

Keywords

Atrium, tachyarrhythmias

Outcome Measures

Primary Outcomes (2)

  • Reduction in AF burden on follow-up

    Reduction in amount of arrhythmia per unit time, compared to prior to the procedure.

    2 years

  • Freedom from arrhythmia on follow-up

    Absence of arrhythmia, defined by clinical thresholds.

    2 years

Secondary Outcomes (1)

  • Clinical status as measured by the EQ5D

    2 years

Other Outcomes (1)

  • Acute Impact of Ablation

    Day zero (that is, during procedure).

Study Arms (1)

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.

Diagnostic Test: No Intervention. Test is computer algorithm.

Interventions

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

Prospective Cohort

Eligibility Criteria

Age21 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • Patients undergoing catheter ablation for atrial arrhythmias

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stanford Hospital

Stanford, California, 94305, United States

Location

Related 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 Electrophysiol. 2017 Jun;28(6):615-622. doi: 10.1111/jce.13177. Epub 2017 Mar 20.

    PMID: 28185348BACKGROUND

  • 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 Atrial Fibrillation Is Terminated by Localized Ablation. Circ Arrhythm Electrophysiol. 2018 Jan;11(1):e005258. doi: 10.1161/CIRCEP.117.005258.

    PMID: 29330332BACKGROUND

  • 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.

    PMID: 29214421BACKGROUND

  • 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 terminates before pulmonary vein isolation. J Cardiovasc Electrophysiol. 2018 May;29(5):687-695. doi: 10.1111/jce.13446. Epub 2018 Feb 22.

    PMID: 29377478BACKGROUND

MeSH Terms

Conditions

Atrial FibrillationAtrial FlutterArrhythmias, CardiacTachycardia

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsCardiac Conduction System Disease

Study Officials

  • Sanjiv Narayan, MD, PhD

    Stanford University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Medicine (CV Medicine)

Study Record Dates

First Submitted

April 25, 2018

First Posted

June 8, 2018

Study Start

June 21, 2018

Primary Completion

January 11, 2021

Study Completion

January 11, 2021

Last Updated

December 2, 2024

Record last verified: 2024-11

Locations

US(1)