NCT04655443

Brief Summary

This is a prospective clinical research study. The objective of this study is to evaluate if clinical risk factors as well as structural features on echocardiography affect the maintenance of sinus rhythm after electrical cardioversion at 30 days. The investigators anticipate 140 patients to be enrolled in the study.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
77

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2017

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
terminated

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

Study Start

First participant enrolled

August 29, 2017

Completed
3.3 years until next milestone

First Submitted

Initial submission to the registry

November 30, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 7, 2020

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 3, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 3, 2021

Completed
Last Updated

July 14, 2021

Status Verified

July 1, 2021

Enrollment Period

3.4 years

First QC Date

November 30, 2020

Last Update Submit

July 8, 2021

Conditions

Atrial Fibrillation

Outcome Measures

Primary Outcomes (1)

  • Transthoracic Echocardiography and Transesophageal Echocardiography findings

    Left ventricular ejection fraction, left ventricular size, left ventricular hypertrophy, left atrial volume index, mitral valve early diastolic inflow velocity E, mitral valve tissue Doppler velocity e', E/e' ratio and pulmonary arterial pressure will be collected from transthoracic echocardiography findings in medical record. Left atrial size, left atrial appendage ejection fraction, left atrial appendage exit velocity, pulmonary venous flow with S/D ratio, and presence of spontaneous echo contrast will be collected from transesophageal echocardiography findings in medical record. Transthoracic Echocardiography and Transesophageal Echocardiography findings between participants that maintained sinus rhythm and participants that developed persistent atrial fibrillation will be compared to create a prediction model to identify specific risk factors, which may contribute to persistent atrial fibrillation.

    30 days post electrical cardioversion

Secondary Outcomes (1)

  • Clinical risk factors

    30 days post electrical cardioversion

Study Arms (2)

Control Group

Patients will be scheduled for an electrocardiogram thirty days after their electrical cardioversion. Based on the electrocardiogram result, patients that maintained sinus rhythm will be assigned to "Control".

Other: Standard Care

Afib Group

Patients will be scheduled for an electrocardiogram thirty days after their electrical cardioversion. Based on the electrocardiogram result, patients that developed persistent atrial fibrillation will be assigned to "Afib".

Other: Standard Care

Interventions

Standard CareOTHER

Standard cardiovascular care

Afib GroupControl Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Adults undergoing electrical cardioversion for atrial fibrillation

You may qualify if:

  • Age \>18 years
  • Documented atrial fibrillation by electrocardiogram (ECG)
  • Patients undergoing electrical cardioversion for atrial fibrillation
  • Patients with a baseline transthoracic echocardiography within 1 month prior to the cardioversion

You may not qualify if:

  • Patients who did not convert to normal sinus rhythm after electrical cardioversion
  • Patients who are found to have a LAA thrombus on TEE
  • Patients who do not have a follow up ECG

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Danbury Hospital

Danbury, Connecticut, 06810, United States

Location

Related Publications (10)

  • January CT, Wann LS, Alpert JS, Calkins H, Cigarroa JE, Cleveland JC Jr, Conti JB, Ellinor PT, Ezekowitz MD, Field ME, Murray KT, Sacco RL, Stevenson WG, Tchou PJ, Tracy CM, Yancy CW; ACC/AHA Task Force Members. 2014 AHA/ACC/HRS guideline for the management of patients with atrial fibrillation: a report of the American College of Cardiology/American Heart Association Task Force on practice guidelines and the Heart Rhythm Society. Circulation. 2014 Dec 2;130(23):e199-267. doi: 10.1161/CIR.0000000000000041. Epub 2014 Mar 28. No abstract available.

    PMID: 24682347RESULT

  • Vlachos K, Letsas KP, Korantzopoulos P, Liu T, Georgopoulos S, Bakalakos A, Karamichalakis N, Xydonas S, Efremidis M, Sideris A. Prediction of atrial fibrillation development and progression: Current perspectives. World J Cardiol. 2016 Mar 26;8(3):267-76. doi: 10.4330/wjc.v8.i3.267.

    PMID: 27022458RESULT

  • Wyse DG, Waldo AL, DiMarco JP, Domanski MJ, Rosenberg Y, Schron EB, Kellen JC, Greene HL, Mickel MC, Dalquist JE, Corley SD; Atrial Fibrillation Follow-up Investigation of Rhythm Management (AFFIRM) Investigators. A comparison of rate control and rhythm control in patients with atrial fibrillation. N Engl J Med. 2002 Dec 5;347(23):1825-33. doi: 10.1056/NEJMoa021328.

    PMID: 12466506RESULT

  • Kim MH, Johnston SS, Chu BC, Dalal MR, Schulman KL. Estimation of total incremental health care costs in patients with atrial fibrillation in the United States. Circ Cardiovasc Qual Outcomes. 2011 May;4(3):313-20. doi: 10.1161/CIRCOUTCOMES.110.958165. Epub 2011 May 3.

    PMID: 21540439RESULT

  • Gilbert KA, Hogarth AJ, MacDonald W, Lewis NT, Tan LB, Tayebjee MH. Restoration of sinus rhythm results in early and late improvements in the functional reserve of the heart following direct current cardioversion of persistent AF: FRESH-AF. Int J Cardiol. 2015 Nov 15;199:121-5. doi: 10.1016/j.ijcard.2015.07.020. Epub 2015 Jul 11.

    PMID: 26188832RESULT

  • Ecker V, Knoery C, Rushworth G, Rudd I, Ortner A, Begley D, Leslie SJ. A review of factors associated with maintenance of sinus rhythm after elective electrical cardioversion for atrial fibrillation. Clin Cardiol. 2018 Jun;41(6):862-870. doi: 10.1002/clc.22931. Epub 2018 Jun 7.

    PMID: 29878481RESULT

  • Malik S, Hicks WJ, Schultz L, Penstone P, Gardner J, Katramados AM, Russman AN, Mitsias P, Silver B. Development of a scoring system for atrial fibrillation in acute stroke and transient ischemic attack patients: the LADS scoring system. J Neurol Sci. 2011 Feb 15;301(1-2):27-30. doi: 10.1016/j.jns.2010.11.011. Epub 2010 Dec 4.

    PMID: 21130468RESULT

  • European Heart Rhythm Association; Heart Rhythm Society; Fuster V, Ryden LE, Cannom DS, Crijns HJ, Curtis AB, Ellenbogen KA, Halperin JL, Le Heuzey JY, Kay GN, Lowe JE, Olsson SB, Prystowsky EN, Tamargo JL, Wann S, Smith SC Jr, Jacobs AK, Adams CD, Anderson JL, Antman EM, Hunt SA, Nishimura R, Ornato JP, Page RL, Riegel B, Priori SG, Blanc JJ, Budaj A, Camm AJ, Dean V, Deckers JW, Despres C, Dickstein K, Lekakis J, McGregor K, Metra M, Morais J, Osterspey A, Zamorano JL; American College of Cardiology; American Heart Association Task Force on Practice Guidelines; European Society of Cardiology Committee for Practice Guidelines; Writing Committee to Revise the 2001 Guidelines for the Management of Patients With Atrial Fibrillation. ACC/AHA/ESC 2006 guidelines for the management of patients with atrial fibrillation--executive summary: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines and the European Society of Cardiology Committee for Practice Guidelines (Writing Committee to Revise the 2001 Guidelines for the Management of Patients With Atrial Fibrillation). J Am Coll Cardiol. 2006 Aug 15;48(4):854-906. doi: 10.1016/j.jacc.2006.07.009. No abstract available.

    PMID: 16904574RESULT

  • Akdemir B, Altekin RE, Kucuk M, Yanikoglu A, Karakas MS, Aktas A, Demir I, Ermis C. The significance of the left atrial volume index in cardioversion success and its relationship with recurrence in patients with non-valvular atrial fibrillation subjected to electrical cardioversion: a study on diagnostic accuracy. Anadolu Kardiyol Derg. 2013 Feb;13(1):18-25. doi: 10.5152/akd.2013.003. Epub 2012 Oct 12.

    PMID: 23070632RESULT

  • Antonielli E, Pizzuti A, Palinkas A, Tanga M, Gruber N, Michelassi C, Varga A, Bonzano A, Gandolfo N, Halmai L, Bassignana A, Imran MB, Delnevo F, Csanady M, Picano E. Clinical value of left atrial appendage flow for prediction of long-term sinus rhythm maintenance in patients with nonvalvular atrial fibrillation. J Am Coll Cardiol. 2002 May 1;39(9):1443-9. doi: 10.1016/s0735-1097(02)01800-4.

    PMID: 11985905RESULT

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Quality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Study Officials

  • Ira Galin, MD

    Danbury Hospital, Nuvance Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 30, 2020

First Posted

December 7, 2020

Study Start

August 29, 2017

Primary Completion

February 3, 2021

Study Completion

February 3, 2021

Last Updated

July 14, 2021

Record last verified: 2021-07

Data Sharing

IPD Sharing
Will not share

Locations

US(1)