Device MalfunctionISEENCT04055740

Intravascular Ultrasound (IVUS) Imaging During Transvenous Lead Extraction

A study testing IVUS Imaging in people with Device Malfunction and ICD, run by University of Chicago at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 21 years and older
Conditions the study is for: Device Malfunction, ICD, Pacemaker Lead Dysfunction
What is being tested?: IVUS Imaging
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 31 participants
Where: 1 siteUnited States
Study dates: 13 Sep 2019to 31 Oct 2021
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 21 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Patients at least 21 years of age
Patients with at least one lead over 1 year dwell time requiring extraction

Who cannot join

Inability of patient capacity to provide consent for themselves either due to medical or psychiatric comorbidity
Venous occlusion to the extent that the IVUS catheter cannot pass
Leads < 1 year dwell time requiring extraction

Trial locations and contacts

1 site in 1 country.

United States1 site

The University of Chicago
Chicago, Illinois, 60637

Other trials in United States

About this study

Official title: Intravascular ultraSound (IVUS) Imaging During transvEnous Lead Extraction (ISEE)

The purpose of this study is to prospectively evaluate intravascular ultrasound (IVUS) imaging as a tool for grading the presence and characterization of intravascular lead adherence (ILA, or scarring) to cardiovascular implantable electronic device (CIED) leads during transvenous lead extraction (TLE) procedures in a multi-center study. IVUS should identify the location and severity of these adhesions, which the investigators will then correlate to difficulty of the extraction procedure using metrics like pulses of laser energy delivered and time required to traverse an area of fibrosis or ILA. The investigators will be focusing primarily on the section from innominate vein (INNV) down through the superior vena cava (SVC) to the right atrium.

Using IVUS to view blood vessels and the heart structure is approved by the Food and Drug Administration (FDA). Using it as described in this study is off label because of the manner in which it is advanced to the SVC, through the right atrium. While it is not restricted from use in this way, it is not specifically on-label. It should be noted that the use of IVUS during TLE procedures as proposed in this study is routine at the University of Chicago and patients will undergo this procedure regardless of participation in this study. The EP physician team regards the use of IVUS during TLE to be nonsignificant risk.

Conditions: Device Malfunction, ICD, Pacemaker Lead Dysfunction
Being tested: IVUS Imaging
Keywords: CIED

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

IVUS ImagingDevice
IVUS or radial-ICE (intracardiac echocardiography) is a visualization tool used in many cardiac procedures including electrophysiology procedures (catheter ablation). Its utility in identifying ILA will be assessed in this study.

Study groups in NCT04055740
Study group	Role	What they receive
IVUS imaging	Experimental	IVUS imaging will be used each patient undergoing transvenous lead extraction to visualize ILA Receives: Device: IVUS Imaging

What is being measured

The primary outcome is the main question the study is designed to answer.

IVUS Grades
Operators will be able to successfully grade the degree of intravascular lead adherence (ILA) seen using IVUS imaging.
Using the following scale, grading of ILA in each zone of interest, based on relative motion of lead will be performed:
1. Grade 1: Freely mobile, Rarely adjacent to vasculature ii. Grade 2: Restricted mobility, Frequently adjacent to vasculature iii. Grade 3: Immobile, Always adjacent to vasculature iv. Grade L, added to number: Lead-to-lead binding
Measured: 6 hours

Secondary outcomes (1)

Extraction Difficulty Metrics
Operators will record the energy and time necessary to traverse binding sites and will be able to correlate these two metrics to IVUS ILA grade
Extraction difficulty was measured by correlating IVUS ILA grade to lead dwell time - the amount of time it took to extract the lead.
Using the following scale, grading of ILA in each zone of interest, based on relative motion of lead was performed:
1. Grade 1: Freely mobile, Rarely adjacent to vasculature ii. Grade 2: Restricted mobility, Frequently adjacent to vasculature iii. Grade 3: Immobile, Always adjacent to vasculature iv. Grade L, added to number: Lead-to-lead binding
Measured: Through study completion, expected to be 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

13 Sep 201931 Oct 2021

First posted14 Aug 2019
Study start13 Sep 2019
Primary completion31 Oct 2021
Study completion31 Oct 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (19)Papers the sponsor has linked to this study.
Other trials for Device MalfunctionStudies of the same condition, open and under way.
More trials run by University of ChicagoThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Model description: Single cohort of patients undergoing transvenous lead extraction
Masking: None (open label)
Enrolment: 31 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04055740
Sponsor's protocol ID: IRB18-1600
Acronym: ISEE
Status last verified: Aug 2023
First submitted: 7 Aug 2019
Last updated: 3 Sep 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Publications

Greenspon AJ, Patel JD, Lau E, Ochoa JA, Frisch DR, Ho RT, Pavri BB, Kurtz SM. 16-year trends in the infection burden for pacemakers and implantable cardioverter-defibrillators in the United States 1993 to 2008. J Am Coll Cardiol. 2011 Aug 30;58(10):1001-6. doi: 10.1016/j.jacc.2011.04.033.
PubMed 21867833
Mond HG, Irwin M, Ector H, Proclemer A. The world survey of cardiac pacing and cardioverter-defibrillators: calendar year 2005 an International Cardiac Pacing and Electrophysiology Society (ICPES) project. Pacing Clin Electrophysiol. 2008 Sep;31(9):1202-12. doi: 10.1111/j.1540-8159.2008.01164.x.
PubMed 18834475
Joy PS, Kumar G, Poole JE, London B, Olshansky B. Cardiac implantable electronic device infections: Who is at greatest risk? Heart Rhythm. 2017 Jun;14(6):839-845. doi: 10.1016/j.hrthm.2017.03.019. Epub 2017 Mar 16.
PubMed 28315744
Kusumoto FM, Schoenfeld MH, Wilkoff BL, Berul CI, Birgersdotter-Green UM, Carrillo R, Cha YM, Clancy J, Deharo JC, Ellenbogen KA, Exner D, Hussein AA, Kennergren C, Krahn A, Lee R, Love CJ, Madden RA, Mazzetti HA, Moore JC, Parsonnet J, Patton KK, Rozner MA, Selzman KA, Shoda M, Srivathsan K, Strathmore NF, Swerdlow CD, Tompkins C, Wazni O. 2017 HRS expert consensus statement on cardiovascular implantable electronic device lead management and extraction. Heart Rhythm. 2017 Dec;14(12):e503-e551. doi: 10.1016/j.hrthm.2017.09.001. Epub 2017 Sep 15. No abstract available.
PubMed 28919379
Brunner MP, Cronin EM, Wazni O, Baranowski B, Saliba WI, Sabik JF, Lindsay BD, Wilkoff BL, Tarakji KG. Outcomes of patients requiring emergent surgical or endovascular intervention for catastrophic complications during transvenous lead extraction. Heart Rhythm. 2014 Mar;11(3):419-25. doi: 10.1016/j.hrthm.2013.12.004. Epub 2013 Dec 4.
PubMed 24315967
Bracke F. Complications and lead extraction in cardiac pacing and defibrillation. Neth Heart J. 2008 Oct;16(Suppl 1):S28-31.
PubMed 18958266
Mazzone P, Tsiachris D, Marzi A, Ciconte G, Paglino G, Sora N, Sala S, Vergara P, Gulletta S, Della Bella P. Predictors of advanced lead extraction based on a systematic stepwise approach: results from a high volume center. Pacing Clin Electrophysiol. 2013 Jul;36(7):837-44. doi: 10.1111/pace.12119. Epub 2013 Mar 19.
PubMed 23510021
Maytin M, Epstein LM, John RM. Lead implant duration does not always predict ease of extraction: extraction sheath may be required at < 1 year. Pacing Clin Electrophysiol. 2011 Dec;34(12):1615-20. doi: 10.1111/j.1540-8159.2011.03225.x. Epub 2011 Oct 20.
PubMed 22017453
Enriquez A, Saenz LC, Rosso R, Silvestry FE, Callans D, Marchlinski FE, Garcia F. Use of Intracardiac Echocardiography in Interventional Cardiology: Working With the Anatomy Rather Than Fighting It. Circulation. 2018 May 22;137(21):2278-2294. doi: 10.1161/CIRCULATIONAHA.117.031343.
PubMed 29784681
Bongiorni MG, Di Cori A, Soldati E, Zucchelli G, Arena G, Segreti L, De Lucia R, Marzilli M. Intracardiac echocardiography in patients with pacing and defibrillating leads: a feasibility study. Echocardiography. 2008 Jul;25(6):632-8. doi: 10.1111/j.1540-8175.2008.00656.x.
PubMed 18652009
Sadek MM, Cooper JM, Frankel DS, Santangeli P, Epstein AE, Marchlinski FE, Schaller RD. Utility of intracardiac echocardiography during transvenous lead extraction. Heart Rhythm. 2017 Dec;14(12):1779-1785. doi: 10.1016/j.hrthm.2017.08.023. Epub 2017 Aug 24.
PubMed 28843419
Santoshi RKN, Lakhanpal S, Satwah V, Lakhanpal G, Malone M, Pappas PJ. Iliac vein stenosis is an underdiagnosed cause of pelvic venous insufficiency. J Vasc Surg Venous Lymphat Disord. 2018 Mar;6(2):202-211. doi: 10.1016/j.jvsv.2017.09.007. Epub 2017 Dec 29.
PubMed 29292119
Ganguli S, Hawkins BM, Abtahian F, Abu-Fadel MS, Walker TG, MacKay C, Jaff MR, Weinberg I. Comparison of Inferior Vena Cava Filters Placed at the Bedside via Intravenous Ultrasound Guidance Versus Fluoroscopic Guidance. Ann Vasc Surg. 2017 Feb;39:250-255. doi: 10.1016/j.avsg.2016.06.013. Epub 2016 Aug 28.
PubMed 27581130
Kassavin DS, Constantinopoulos G. The transition to IVUS-guided IVC filter deployment in the nontrauma patient. Vasc Endovascular Surg. 2011 Feb;45(2):142-5. doi: 10.1177/1538574410393753. Epub 2011 Jan 28.
PubMed 21278179
Jeyabalan G, Wallace JR, Chaer RA, Leers SA, Marone LK, Makaroun MS. Endovascular strategies for treatment of embolizing thoracoabdominal aortic lesions. J Vasc Surg. 2014 May;59(5):1256-64. doi: 10.1016/j.jvs.2013.11.068. Epub 2014 Jan 14.
PubMed 24433783

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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All Device Malfunction trials

Study at a glance

From the registry record, last updated by the sponsor on 3 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Intravascular ultraSound (IVUS) Imaging During transvEnous Lead Extraction (ISEE)
ClinicalTrials.gov ID: NCT04055740
Acronym / sponsor ID: ISEE / IRB18-1600
Conditions: Device Malfunction, ICD, Pacemaker Lead Dysfunction
Keywords: CIED
Study type: Interventional
Recruitment status: Completed
Enrolment: 31 participants (actual)
Lead sponsor: University of ChicagoUniversity, hospital or other
Study start: 13 Sep 2019 (actual)
Primary completion: 31 Oct 2021 (actual)
Study completion: 31 Oct 2021 (actual)
First posted: 14 Aug 2019 (actual)
Results: Posted 3 Sep 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1
Model description: Single cohort of patients undergoing transvenous lead extraction

Arm	Type	Receives
IVUS imaging	Experimental	Device: IVUS ImagingIVUS imaging will be used each patient undergoing transvenous lead extraction to visualize ILA

Who may qualify

Ages: 21 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

Patients at least 21 years of age
Patients with at least one lead over 1 year dwell time requiring extraction

Key exclusion criteria (3 listed)

Inability of patient capacity to provide consent for themselves either due to medical or psychiatric comorbidity
Venous occlusion to the extent that the IVUS catheter cannot pass
Leads < 1 year dwell time requiring extraction

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
IVUS ImagingIVUS or radial-ICE (intracardiac echocardiography) is a visualization tool used in many cardiac procedures including electrophysiology procedures (catheter ablation). Its utility in identifying ILA will be assessed in this study.	Device	IVUS imaging

Primary outcome

IVUS Grades
Time frame: 6 hours
Operators will be able to successfully grade the degree of intravascular lead adherence (ILA) seen using IVUS imaging. Using the following scale, grading of ILA in each zone of interest, based on relative motion of lead will be performed: i. Grade 1: Freely mobile, Rarely adjacent to vasculature ii. Grade 2: Restricted mobility, Frequently adjacent to vasculature iii. Grade 3: Immobile, Always adjacent to vasculature iv. Grade L, added to number: Lead-to-lead binding

1 secondary outcome

Extraction Difficulty Metrics
Time frame: Through study completion, expected to be 6 months

Results and safety

Results posted to the registry on 3 Sep 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
IVUS Imaging	31	31

Primary outcome: IVUS Grades

Time frame: 6 hours. Mean (Standard Deviation). Unit: Grade

Measure	IVUS Imaging n = 28
Right sided devices Zone1/2	1.33 (0.58)
Right sided devices Zone 3	1 (0)
Left sided devices Zone 1	1.57 (0.81)
Left sided devices Zone 2	1.44 (0.58)
Left sided devices Zone 3	1.32 (0.63)
All devices, all zones	1.40 (0.50)

IVUS Imaging: p = 0.2201, Spearman Correlation Coefficient
IVUS Imaging: p = 0.5157, Spearman Correlation Coefficient

Population analysed: 3 patients did not have any ILA grades.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: 1 year. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
IVUS Imaging	0 of 31 (0%)	0 of 31 (0%)	0 of 31

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 21867833Greenspon AJ, Patel JD, Lau E, Ochoa JA, Frisch DR, Ho RT, Pavri BB, Kurtz SM. 16-year trends in the infection burden for pacemakers and implantable cardioverter-defibrillators in the United States 1993 to 2008. J Am Coll Cardiol. 2011 Aug 30;58(10):1001-6. doi: 10.1016/j.jacc.2011.04.033.
Background: PubMed 18834475Mond HG, Irwin M, Ector H, Proclemer A. The world survey of cardiac pacing and cardioverter-defibrillators: calendar year 2005 an International Cardiac Pacing and Electrophysiology Society (ICPES) project. Pacing Clin Electrophysiol. 2008 Sep;31(9):1202-12. doi: 10.1111/j.1540-8159.2008.01164.x.
Background: PubMed 28315744Joy PS, Kumar G, Poole JE, London B, Olshansky B. Cardiac implantable electronic device infections: Who is at greatest risk? Heart Rhythm. 2017 Jun;14(6):839-845. doi: 10.1016/j.hrthm.2017.03.019. Epub 2017 Mar 16.
Background: PubMed 28919379Kusumoto FM, Schoenfeld MH, Wilkoff BL, Berul CI, Birgersdotter-Green UM, Carrillo R, Cha YM, Clancy J, Deharo JC, Ellenbogen KA, Exner D, Hussein AA, Kennergren C, Krahn A, Lee R, Love CJ, Madden RA, Mazzetti HA, Moore JC, Parsonnet J, Patton KK, Rozner MA, Selzman KA, Shoda M, Srivathsan K, Strathmore NF, Swerdlow CD, Tompkins C, Wazni O. 2017 HRS expert consensus statement on cardiovascular implantable electronic device lead management and extraction. Heart Rhythm. 2017 Dec;14(12):e503-e551. doi: 10.1016/j.hrthm.2017.09.001. Epub 2017 Sep 15. No abstract available.
Background: PubMed 24315967Brunner MP, Cronin EM, Wazni O, Baranowski B, Saliba WI, Sabik JF, Lindsay BD, Wilkoff BL, Tarakji KG. Outcomes of patients requiring emergent surgical or endovascular intervention for catastrophic complications during transvenous lead extraction. Heart Rhythm. 2014 Mar;11(3):419-25. doi: 10.1016/j.hrthm.2013.12.004. Epub 2013 Dec 4.
Background: PubMed 18958266Bracke F. Complications and lead extraction in cardiac pacing and defibrillation. Neth Heart J. 2008 Oct;16(Suppl 1):S28-31.
Background: PubMed 23510021Mazzone P, Tsiachris D, Marzi A, Ciconte G, Paglino G, Sora N, Sala S, Vergara P, Gulletta S, Della Bella P. Predictors of advanced lead extraction based on a systematic stepwise approach: results from a high volume center. Pacing Clin Electrophysiol. 2013 Jul;36(7):837-44. doi: 10.1111/pace.12119. Epub 2013 Mar 19.
Background: PubMed 22017453Maytin M, Epstein LM, John RM. Lead implant duration does not always predict ease of extraction: extraction sheath may be required at < 1 year. Pacing Clin Electrophysiol. 2011 Dec;34(12):1615-20. doi: 10.1111/j.1540-8159.2011.03225.x. Epub 2011 Oct 20.
Background: PubMed 29784681Enriquez A, Saenz LC, Rosso R, Silvestry FE, Callans D, Marchlinski FE, Garcia F. Use of Intracardiac Echocardiography in Interventional Cardiology: Working With the Anatomy Rather Than Fighting It. Circulation. 2018 May 22;137(21):2278-2294. doi: 10.1161/CIRCULATIONAHA.117.031343.
Background: PubMed 18652009Bongiorni MG, Di Cori A, Soldati E, Zucchelli G, Arena G, Segreti L, De Lucia R, Marzilli M. Intracardiac echocardiography in patients with pacing and defibrillating leads: a feasibility study. Echocardiography. 2008 Jul;25(6):632-8. doi: 10.1111/j.1540-8175.2008.00656.x.
Background: PubMed 28843419Sadek MM, Cooper JM, Frankel DS, Santangeli P, Epstein AE, Marchlinski FE, Schaller RD. Utility of intracardiac echocardiography during transvenous lead extraction. Heart Rhythm. 2017 Dec;14(12):1779-1785. doi: 10.1016/j.hrthm.2017.08.023. Epub 2017 Aug 24.
Background: PubMed 29292119Santoshi RKN, Lakhanpal S, Satwah V, Lakhanpal G, Malone M, Pappas PJ. Iliac vein stenosis is an underdiagnosed cause of pelvic venous insufficiency. J Vasc Surg Venous Lymphat Disord. 2018 Mar;6(2):202-211. doi: 10.1016/j.jvsv.2017.09.007. Epub 2017 Dec 29.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Hemal Nayak, MD principal investigator

University of Chicago

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing IVUS Imaging in people with Device Malfunction and ICD, run by University of Chicago at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 3 Sep 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

IVUS Grades (time frame: 6 hours). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04055740, which also lists 19 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2024.