NCT02111993

Brief Summary

The objective of this study is to evaluate myocardial injury, if any, as quantified by cardiac markers (Troponin-T) in defibrillation threshold (DFT) testing during implantation of implantable cardioverter defibrillators (ICDs) using the upper limit of vulnerability (ULV) method vs. standard defibrillation threshold method.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2011

Longer than P75 for not_applicable

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

Study Start

First participant enrolled

August 1, 2011

Completed
2.7 years until next milestone

First Submitted

Initial submission to the registry

April 9, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 11, 2014

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2015

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
4 years until next milestone

Results Posted

Study results publicly available

May 22, 2019

Completed
Last Updated

May 22, 2019

Status Verified

May 1, 2019

Enrollment Period

3.7 years

First QC Date

April 9, 2014

Results QC Date

March 8, 2016

Last Update Submit

May 20, 2019

Conditions

CardiomyopathyHeart FailureCardiac Arrhythmia

Keywords

Defibrillation testingUpper Limit of VulnerabilityULVDFTICDimplantable cardioverter defibrillatorcardiomyopathycardiac arrhythmiacardiac device testing

Outcome Measures

Primary Outcomes (1)

  • Myocardial Damage

    Myocardial damage will be evaluated by cardiac troponin (cTNT) lab collection before and then after ULV or DFT testing at 4 hours, 8 hours, and 20 hours.

    20 hours (hr)

Secondary Outcomes (2)

  • Defibrillation Testings (DFT) vs. Upper Limit of Vulnerability (ULV) (VF Induced)

    20 hours (hr)

  • Defibrillation Testing (DFT) Versus Upper Limit of Vulnerability (ULV) (Non-induced)

    20 hours (hr)

Study Arms (2)

Standard Defibrillation Testing

ACTIVE COMPARATOR

Standard Defibrillation Threshold Testing is a procedure in which a low energy shock will be delivered to the heart to induce ventricular fibrillation (VF) followed by a rescue shock to restore sinus rhythm. Process is repeated after 5 minutes.

Device: Standard Defibrillation Testing

Upper Limit of VulnerabilityTesting

ACTIVE COMPARATOR

Upper Limit of Vulnerability Testing is a procedure in which four 18J shocks will be delivered at specified intervals. If VF is induced, then a 25 J rescue shock will be delivered.

Device: Upper Limit of Vulnerability Testing

Interventions

Standard Defibrillation TestingDEVICE

Once the ICD is implanted, Standard Defibrillation Threshold (DFT) testing will begin. A low energy shock will be delivered to the heart at the peak of the T wave to induce ventricular fibrillation (VF). Once VF is induced, a rescue shock of 25J will be delivered to restore sinus rhythm. This process will be repeated once more after 5 minutes.

Also known as: ICD implantation
Standard Defibrillation Testing
Upper Limit of Vulnerability TestingDEVICE

Once the ICD is implanted, Upper Limit of Vulnerability (ULV) testing will commence. An 18 J shock will be delivered will at different points from the t-wave. If VF is not induced with any of these shocks, then the ULV will be considered to be 18J. If VF is induced, then a 25 J rescue shock will be delivered.

Also known as: ICD implantation
Upper Limit of VulnerabilityTesting

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients eligible to receive an ICD implant or change out.
  • Patients with a single or dual coil right ventricle (RV) defibrillation lead located in the RV apex.
  • Patients greater than 18 years of age.
  • Patients willing and able to give informed consent.
  • Patients who have insurance which may cover additional hospital stay if myocardial injury resulted from testing

You may not qualify if:

  • Patients with medical conditions that would limit study participation.
  • Patients that are pregnant

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UCSD Sulpizio Cardiovascular Center

La Jolla, California, 92093, United States

Location

Related Publications (13)

  • Swerdlow CD, Shehata M, Chen PS. Using the upper limit of vulnerability to assess defibrillation efficacy at implantation of ICDs. Pacing Clin Electrophysiol. 2007 Feb;30(2):258-70. doi: 10.1111/j.1540-8159.2007.00659.x.

    PMID: 17338725BACKGROUND

  • Day JD, Doshi RN, Belott P, Birgersdotter-Green U, Behboodikhah M, Ott P, Glatter KA, Tobias S, Frumin H, Lee BK, Merillat J, Wiener I, Wang S, Grogin H, Chun S, Patrawalla R, Crandall B, Osborn JS, Weiss JP, Lappe DL, Neuman S. Inductionless or limited shock testing is possible in most patients with implantable cardioverter- defibrillators/cardiac resynchronization therapy defibrillators: results of the multicenter ASSURE Study (Arrhythmia Single Shock Defibrillation Threshold Testing Versus Upper Limit of Vulnerability: Risk Reduction Evaluation With Implantable Cardioverter-Defibrillator Implantations). Circulation. 2007 May 8;115(18):2382-9. doi: 10.1161/CIRCULATIONAHA.106.663112. Epub 2007 Apr 30.

    PMID: 17470697BACKGROUND

  • Chen PS, Shibata N, Dixon EG, Martin RO, Ideker RE. Comparison of the defibrillation threshold and the upper limit of ventricular vulnerability. Circulation. 1986 May;73(5):1022-8. doi: 10.1161/01.cir.73.5.1022.

    PMID: 3698224BACKGROUND

  • Chen PS, Feld GK, Kriett JM, Mower MM, Tarazi RY, Fleck RP, Swerdlow CD, Gang ES, Kass RM. Relation between upper limit of vulnerability and defibrillation threshold in humans. Circulation. 1993 Jul;88(1):186-92. doi: 10.1161/01.cir.88.1.186.

    PMID: 8319332BACKGROUND

  • Hwang C, Swerdlow CD, Kass RM, Gang ES, Mandel WJ, Peter CT, Chen PS. Upper limit of vulnerability reliably predicts the defibrillation threshold in humans. Circulation. 1994 Nov;90(5):2308-14. doi: 10.1161/01.cir.90.5.2308.

    PMID: 7955188BACKGROUND

  • Martin DJ, Chen PS, Hwang C, Gang ES, Mandel WJ, Peter CT, Swerdlow CD. Upper limit of vulnerability predicts chronic defibrillation threshold for transvenous implantable defibrillators. J Cardiovasc Electrophysiol. 1997 Mar;8(3):241-8. doi: 10.1111/j.1540-8167.1997.tb00786.x.

    PMID: 9083873BACKGROUND

  • Birgersdotter-Green U, Undesser K, Fujimura O, Feld GK, Kass RM, Mandel WJ, Peter CT, Chen PS. Correlation of acute and chronic defibrillation threshold with upper limit of vulnerability determined in normal sinus rhythm. J Interv Card Electrophysiol. 1999 Jul;3(2):155-61. doi: 10.1023/a:1009825731592.

    PMID: 10387143BACKGROUND

  • Swerdlow CD, Davie S, Ahern T, Chen PS. Comparative reproducibility of defibrillation threshold and upper limit of vulnerability. Pacing Clin Electrophysiol. 1996 Dec;19(12 Pt 1):2103-11. doi: 10.1111/j.1540-8159.1996.tb03285.x.

    PMID: 8994950BACKGROUND

  • Swerdlow CD, Ahern T, Kass RM, Davie S, Mandel WJ, Chen PS. Upper limit of vulnerability is a good estimator of shock strength associated with 90% probability of successful defibrillation in humans with transvenous implantable cardioverter-defibrillators. J Am Coll Cardiol. 1996 Apr;27(5):1112-8. doi: 10.1016/0735-1097(95)00603-6.

    PMID: 8609329BACKGROUND

  • Swerdlow CD. Implantation of cardioverter defibrillators without induction of ventricular fibrillation. Circulation. 2001 May 1;103(17):2159-64. doi: 10.1161/01.cir.103.17.2159.

    PMID: 11331256BACKGROUND

  • Green UB, Garg A, Al-Kandari F, Ungab G, Tone L, Feld GK. Successful implantation of cardiac defibrillators without induction of ventricular fibrillation using upper limit of vulnerability testing. J Interv Card Electrophysiol. 2003 Feb;8(1):71-5. doi: 10.1023/a:1022304417889.

    PMID: 12652181BACKGROUND

  • Swerdlow C, Shivkumar K, Zhang J. Determination of the upper limit of vulnerability using implantable cardioverter-defibrillator electrograms. Circulation. 2003 Jun 24;107(24):3028-33. doi: 10.1161/01.CIR.0000074220.19414.18. Epub 2003 Jun 16.

    PMID: 12810611BACKGROUND

  • Shehata M, Belk P, Kremers M, Saba S, Cao J, Swerdlow CD. Automatic determination of timing intervals for upper limit of vulnerability using ICD electrograms. Pacing Clin Electrophysiol. 2008 Jun;31(6):691-700. doi: 10.1111/j.1540-8159.2008.01072.x.

    PMID: 18507541BACKGROUND

MeSH Terms

Conditions

CardiomyopathiesHeart FailureArrhythmias, Cardiac

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Ulrika Birgersdotter-Green, MD
Organization
UC San Diego School of Medicine
ubgreen@ucsd.edu
858-657-5310

Study Officials

  • Ulrika Birgersdotter-Green, MD

    University of California, San Diego

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

April 9, 2014

First Posted

April 11, 2014

Study Start

August 1, 2011

Primary Completion

April 1, 2015

Study Completion

June 1, 2015

Last Updated

May 22, 2019

Results First Posted

May 22, 2019

Record last verified: 2019-05

Locations

US(1)