Study of Paced QRS Duration as a Marker of Sudden Cardiac Death

NCT01948206 | Terminated

• 1 other identifier: PMC001
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the study is to determine whether prolonged paced QRS duration is a marker of sudden cardiac death in subjects with implantable cardioverter-defibrillators (ICD).

Conditions

Sudden Cardiac Death

Keywords

Sudden Cardiac Death; Implantable Cardioverter-Defibrillator; Cardiomyopathy; Prolonged Paced QRS Duration

Outcome Measures

Primary Outcomes (1)

• Sudden Cardiac Death

  Subjects will be considered to have suffered SCD if they meet one of the following criteria. * An appropriate ICD therapy (shock or anti-tachycardia pacing) * Death occurring within one hour of onset of cardiac symptoms * Death during sleep * Unwitnessed death in a formerly stable patient * Death during attempted resuscitation

  Subjects will be followed for the duration of the study, an expected average of 2.5 years

Study Arms (2)

Prolonged paced QRS group

Patients with implantable cardioverter-defibrillators with Prolonged Paced(\>=150ms) QRS duration

Narrow paced QRS group

Patients with Implantable Cardioverter-Defibrillators with Narrow Paced(\<150ms) QRS duration

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects followed in the ICD clinic at Pocono Medical Center.

You may qualify if:

• years old or older
• Male or female
• Subjects followed in the ICD clinic at Pocono Medical Center who have undergone ICD implantation within 3 years prior to the date of enrollment, and those who undergo ICD implantation during the enrollment period, whether for primary prevention or for secondary prevention based on standard indications will be included in the study.
• Patients with single chamber, dual chamber and biventricular devices manufactured by all three major vendors (Boston Scientific, St Jude Medical and Medtronic) will be considered.

You may not qualify if:

• Life expectancy of less than one year
• Severe reaction to the adhesive material on ECG patches

Sponsors & Collaborators

• Pocono Medical Center: lead

Study Sites (1)

Pocono Medical Center Physicians Associates-Cardiology

East Stroudsburg, Pennsylvania, 18301, United States

Location

Related Publications (18)

• Roger VL, Go AS, Lloyd-Jones DM, Benjamin EJ, Berry JD, Borden WB, Bravata DM, Dai S, Ford ES, Fox CS, Fullerton HJ, Gillespie C, Hailpern SM, Heit JA, Howard VJ, Kissela BM, Kittner SJ, Lackland DT, Lichtman JH, Lisabeth LD, Makuc DM, Marcus GM, Marelli A, Matchar DB, Moy CS, Mozaffarian D, Mussolino ME, Nichol G, Paynter NP, Soliman EZ, Sorlie PD, Sotoodehnia N, Turan TN, Virani SS, Wong ND, Woo D, Turner MB; American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Executive summary: heart disease and stroke statistics--2012 update: a report from the American Heart Association. Circulation. 2012 Jan 3;125(1):188-97. doi: 10.1161/CIR.0b013e3182456d46. No abstract available.

  PMID: 22215894 BACKGROUND

• Greve AM, Gerdts E, Boman K, Gohlke-Baerwolf C, Rossebo AB, Devereux RB, Kober L, Ray S, Willenheimer R, Wachtell K. Impact of QRS duration and morphology on the risk of sudden cardiac death in asymptomatic patients with aortic stenosis: the SEAS (Simvastatin and Ezetimibe in Aortic Stenosis) Study. J Am Coll Cardiol. 2012 Mar 27;59(13):1142-9. doi: 10.1016/j.jacc.2011.12.020.

  PMID: 22440214 BACKGROUND

• Koyak Z, Harris L, de Groot JR, Silversides CK, Oechslin EN, Bouma BJ, Budts W, Zwinderman AH, Van Gelder IC, Mulder BJ. Sudden cardiac death in adult congenital heart disease. Circulation. 2012 Oct 16;126(16):1944-54. doi: 10.1161/CIRCULATIONAHA.112.104786. Epub 2012 Sep 18.

  PMID: 22991410 BACKGROUND

• Varma N. Left ventricular conduction delays induced by right ventricular apical pacing: effect of left ventricular dysfunction and bundle branch block. J Cardiovasc Electrophysiol. 2008 Feb;19(2):114-22. doi: 10.1111/j.1540-8167.2007.00995.x. Epub 2007 Oct 24.

  PMID: 17971145 BACKGROUND

• Sweeney MO, Hellkamp AS. Heart failure during cardiac pacing. Circulation. 2006 May 2;113(17):2082-8. doi: 10.1161/CIRCULATIONAHA.105.608356. Epub 2006 Apr 24.

  PMID: 16636167 BACKGROUND

• Hsing JM, Selzman KA, Leclercq C, Pires LA, McLaughlin MG, McRae SE, Peterson BJ, Zimetbaum PJ. Paced left ventricular QRS width and ECG parameters predict outcomes after cardiac resynchronization therapy: PROSPECT-ECG substudy. Circ Arrhythm Electrophysiol. 2011 Dec;4(6):851-7. doi: 10.1161/CIRCEP.111.962605. Epub 2011 Sep 28.

  PMID: 21956038 BACKGROUND

• Pap R, Furge P, Bencsik G, Makai A, Saghy L, Forster T. Native QRS complex duration predicts paced QRS width in patients with normal left ventricular function and right ventricular pacing for atrioventricular block. J Electrocardiol. 2007 Oct;40(4):360-4. doi: 10.1016/j.jelectrocard.2006.10.060. Epub 2007 Jan 24.

  PMID: 17254598 BACKGROUND

• Tracy CM, Epstein AE, Darbar D, Dimarco JP, Dunbar SB, Estes NA 3rd, Ferguson TB Jr, Hammill SC, Karasik PE, Link MS, Marine JE, Schoenfeld MH, Shanker AJ, Silka MJ, Stevenson LW, Stevenson WG, Varosy PD. 2012 ACCF/AHA/HRS focused update of the 2008 guidelines for device-based therapy of cardiac rhythm abnormalities: a report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines. J Am Coll Cardiol. 2012 Oct 2;60(14):1297-313. doi: 10.1016/j.jacc.2012.07.009. Epub 2012 Sep 10. No abstract available.

  PMID: 22975230 BACKGROUND

• Kurl S, Makikallio TH, Rautaharju P, Kiviniemi V, Laukkanen JA. Duration of QRS complex in resting electrocardiogram is a predictor of sudden cardiac death in men. Circulation. 2012 May 29;125(21):2588-94. doi: 10.1161/CIRCULATIONAHA.111.025577. Epub 2012 May 21.

  PMID: 22615341 RESULT

• Teodorescu C, Reinier K, Uy-Evanado A, Navarro J, Mariani R, Gunson K, Jui J, Chugh SS. Prolonged QRS duration on the resting ECG is associated with sudden death risk in coronary disease, independent of prolonged ventricular repolarization. Heart Rhythm. 2011 Oct;8(10):1562-7. doi: 10.1016/j.hrthm.2011.06.011. Epub 2011 Jun 12.

  PMID: 21699869 RESULT

• Bode-Schnurbus L, Bocker D, Block M, Gradaus R, Heinecke A, Breithardt G, Borggrefe M. QRS duration: a simple marker for predicting cardiac mortality in ICD patients with heart failure. Heart. 2003 Oct;89(10):1157-62. doi: 10.1136/heart.89.10.1157.

  PMID: 12975406 RESULT

• Morin DP, Oikarinen L, Viitasalo M, Toivonen L, Nieminen MS, Kjeldsen SE, Dahlof B, John M, Devereux RB, Okin PM. QRS duration predicts sudden cardiac death in hypertensive patients undergoing intensive medical therapy: the LIFE study. Eur Heart J. 2009 Dec;30(23):2908-14. doi: 10.1093/eurheartj/ehp321. Epub 2009 Aug 17.

  PMID: 19687165 RESULT

• Hayes JJ, Sharma AD, Love JC, Herre JM, Leonen AO, Kudenchuk PJ; DAVID Investigators. Abnormal conduction increases risk of adverse outcomes from right ventricular pacing. J Am Coll Cardiol. 2006 Oct 17;48(8):1628-33. doi: 10.1016/j.jacc.2006.05.071. Epub 2006 Sep 26.

  PMID: 17045899 RESULT

• Buxton AE, Sweeney MO, Wathen MS, Josephson ME, Otterness MF, Hogan-Miller E, Stark AJ, Degroot PJ; PainFREE Rx II Investigators. QRS duration does not predict occurrence of ventricular tachyarrhythmias in patients with implanted cardioverter-defibrillators. J Am Coll Cardiol. 2005 Jul 19;46(2):310-6. doi: 10.1016/j.jacc.2005.03.060.

  PMID: 16022960 RESULT

• Bauer A, Watanabe MA, Barthel P, Schneider R, Ulm K, Schmidt G. QRS duration and late mortality in unselected post-infarction patients of the revascularization era. Eur Heart J. 2006 Feb;27(4):427-33. doi: 10.1093/eurheartj/ehi683. Epub 2005 Dec 7.

  PMID: 16338936 RESULT

• Murkofsky RL, Dangas G, Diamond JA, Mehta D, Schaffer A, Ambrose JA. A prolonged QRS duration on surface electrocardiogram is a specific indicator of left ventricular dysfunction [see comment]. J Am Coll Cardiol. 1998 Aug;32(2):476-82. doi: 10.1016/s0735-1097(98)00242-3.

  PMID: 9708478 RESULT

• Stewart RA, Young AA, Anderson C, Teo KK, Jennings G, Cowan BR. Relationship between QRS duration and left ventricular mass and volume in patients at high cardiovascular risk. Heart. 2011 Nov;97(21):1766-70. doi: 10.1136/heartjnl-2011-300297. Epub 2011 Aug 11.

  PMID: 21835757 RESULT

• Schueller PO, Hennersdorf MG, Strauer BE. Sudden death is associated with a widened paced QRS complex in noncoronary cardiac disease. J Interv Card Electrophysiol. 2006 Mar;15(2):125-30. doi: 10.1007/s10840-006-8345-9.

  PMID: 16755342 RESULT

MeSH Terms

Conditions

Death, Sudden, Cardiac; Cardiomyopathies

Condition Hierarchy (Ancestors)

Heart Arrest; Heart Diseases; Cardiovascular Diseases; Death, Sudden; Death; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Praveer Jain, M.D.

  Pocono Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: September 12, 2013
• First Posted: September 23, 2013
• Study Start: October 1, 2013
• Primary Completion: October 1, 2016
• Study Completion: October 1, 2016
• Last Updated: December 13, 2016

Record last verified: 2016-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)