NCT02027883

Brief Summary

As the indications for Implantable Cardioverter Defibrillator implantation expand, minimizing implant time is critical. Also, patients receiving biventricular ICDs are sometimes more unstable and minimization of sedation time is crucial. Multiple induction attempts, with a 1-Joule shock, can cause disruption in lead position. Therefore limiting the number of attempts will allow for better lead stability throughout the procedure and a more straightforward implant process. Investigator proposes a detailed documentation of success rates from various Ventriculart Fibrillation induction methods during implant of Medtronic defibrillation capable devices.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2011

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

January 1, 2011

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2012

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

December 31, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 6, 2014

Completed
12 months until next milestone

Results Posted

Study results publicly available

December 30, 2014

Completed
Last Updated

May 22, 2018

Status Verified

April 1, 2018

Enrollment Period

1.6 years

First QC Date

December 31, 2013

Results QC Date

June 24, 2014

Last Update Submit

April 23, 2018

Conditions

Cardiomyopathy

Keywords

DefibrillatorsVentricular Fibrillation Induction Testing

Outcome Measures

Primary Outcomes (1)

  • Sustained Ventricular Fibrillation

    The primary endpoint is the successful induction of sustained ventricular fibrillation.

    2 hours

Secondary Outcomes (1)

  • Factors

    2 hours

Other Outcomes (1)

  • Safety Monitoring

    2 hours

Study Arms (2)

Nominal Parameter

ACTIVE COMPARATOR

Nominal T shock setting

Device: Nominal T shock setting

Experimental Parameter

EXPERIMENTAL

Educated T shock setting

Device: Educated T shock setting

Interventions

Nominal T shock settingDEVICE

Nominal Parameter Set 1 Programming Values for EnTrust

Also known as: Medtronic ICDs
Nominal Parameter
Educated T shock settingDEVICE

Experimental Parameter Set 2 Programming Values

Also known as: Medtronic ICDs
Experimental Parameter

Eligibility Criteria

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

You may qualify if:

  • All patients undergoing Medtronic ICD or Cardiac Resynchronization Therapy-Defibrillator implant (initial implant or generator replacement) will be included.

You may not qualify if:

  • Any patient who is medically unstable and testing is deemed unsafe by physician will be excluded from this study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wellmont CVA Heart Institute

Kingsport, Tennessee, 37660, United States

Location

Related Publications (5)

  • Bardy G, Mehra R, Johnson G, Kudenchuk P, Dolack G, Poole J, Hofer B: Low energy pulsing on the T-wave: A new programming method for intentional, device mediated induction of ventricular fibrillation for defibrillation testing. PACE 15(4, Pt II): 562, 1992.

    BACKGROUND

  • Bhandari AK, Isber N, Estioko M, Ziccardi T, Cannom DS, Park Y, Lerman RD, Prejean C, Sun GW. Efficacy of low-energy T wave shocks for induction of ventricular fibrillation in patients with implantable cardioverter defibrillators. J Electrocardiol. 1998 Jan;31(1):31-7. doi: 10.1016/s0022-0736(98)90004-8.

    PMID: 9533375BACKGROUND

  • Marquis DR Reference Manual, Medtronic, Inc.

    BACKGROUND

  • Mitchell L, Yee R, Talajic M, Newman D, Sheldon R, Kerr C, Kus T, Boyle A, Canadian Jewel PCD Investigators: Low-energy, T-wave synchronous, interval shock for rapid, reliable ventricular fibrillation induction by an implantable cardioverter defibrllattor. PACE, 17(4, Pt II): 851, 1994.

    BACKGROUND

  • Swartz J, Stanton M, DeGroot P, Mehra R: Influence of T-wave shock energy on ventricular fibrillation vulnerability in humans. JACC 1995 Conference Abstracts: 214A, 1995.

    BACKGROUND

MeSH Terms

Conditions

Cardiomyopathies

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Results Point of Contact

Title
Terrie Walker, Director of Clinical Research
Organization
Wellmont CVA Heart Institute
twalker@mycva.com
423-230-5643

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
James Merrill, MD, FACC

Study Record Dates

First Submitted

December 31, 2013

First Posted

January 6, 2014

Study Start

January 1, 2011

Primary Completion

August 1, 2012

Study Completion

August 1, 2012

Last Updated

May 22, 2018

Results First Posted

December 30, 2014

Record last verified: 2018-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)