Mechanical Complication of Cardiac Electronic DeviceMILESNCT03772704
Multicenter Imaging in Lead Extraction Study
An observational study of Mechanical Complication of Cardiac Electronic Device, run by The Cleveland Clinic at 5 sites in 2 countries.
Trial summary
The primary objectives of this registry is to correlate the amount of fibrosis as documented on Electrocardiogram (ECG) gated Computed Tomography (CT) scans with ease of advancing sheaths over the leads through the SVC zone during lead extraction. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Mechanical Complication of Cardiac Electronic Device
- How many people
- 200 participants
- Where
- 5 sitesin 2 countries
- Study dates
- 13 Dec 2018to 4 Nov 2020
- How long will I take part?
- 30 Days
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Referred patients for CIED lead extraction
Who may be able to join
- Referred for CIED (Cardiac Implantable Electronic Device) lead extraction with at least 1 lead with dwell time greater than one year
- ≥ 18 years of age
- Appropriate candidate for chest/cardiac CT with contrast and full lead analysis
Who cannot join
- Atrial fibrillation with uncontrolled rate
Trial locations and contacts
5 sites in 2 countries.
5 sites in 2 countries
United States4 sites
Cleveland Clinic
Cleveland, Ohio, 44195
Duke University
Durham, North Carolina, 27710
Northwell Health
Manhasset, New York, 11030
United Heart and Vascular Clinic
Saint Paul, Minnesota, 55102
About this study
The primary objectives of this registry is to correlate the amount of fibrosis as documented on Electrocardiogram (ECG) gated Computed Tomography (CT) scans with ease of advancing sheaths over the leads through the SVC zone during lead extraction.
Read the detailed description
This is a multi-center, prospective, observational registry study which plans to enroll approximately 200 patients referred for Cardiac Implantable Electronic Device(CIED) lead extraction at one of the five study centers. The objective of this study is to determine whether a correlation exists between fibrosis detected on ECG gated cardiac CT and the ease of lead extraction as measured by need for extraction energy. All patients will be followed for 30 days post-lead extraction to assess vital status and re-hospitalizations via phone call
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation of the presence and degree of fibrosis as determined by ECG gated cardiac CT with the presence and degree of fibrosis determined by ease of extraction sheath advancement
The presence and degree of fibrosis determined by the ease of extraction sheath advancement will be evaluated in three zones. Zone 1 will be the area before the Superior Vena Cava (SVC), Zone 2 in the SVC and Zone 3 after the SVC
Measured: 30 days
Secondary outcomes (8)
Percentage of ECG gated CT scans that show fibrosis
The percentage of ECG gated CT scans will be determined by scans that show little to no SVC (Zone 2) fibrosis, show little to no Zone 1 fibrosis, show little to no Zone 3 fibrosis, cardiac perforation, extravascular lead location
Measured: 30 days
Major complications as defined by Heart Rhythm Society (HRS) 2017 consensus guidelines
major complications
Measured: 30 days
Minor complications as defined by HRS 2017 consensus guidelines
minor complications
Measured: 30 days
Mortality
Death assessed
Measured: 30 days
Procedural outcomes
Operator ease of extraction (grade 1-5)
Measured: 30 days
Fluoroscopy time
Fluoroscopy duration of time
Measured: 30 days
Pathological reports from extracted leads
Pathology reports from extracted leads if available
Measured: 30 days
Hospitalizations directly related to the extraction of leads or procedure related
Number of hospitalizations related to the extraction of leads or procedure related within 30 days post procedure
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2018
- Study start13 Dec 2018
- Primary completion4 Nov 2020
- Study completion4 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Mechanical Complication of Cardiac Electronic DeviceStudies of the same condition, open and under way.
- More trials run by The Cleveland ClinicThe 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 200 participants (actual)
- Target duration
- 30 Days
Sponsor and investigators
- Lead sponsor
- The Cleveland Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- Philips Healthcare
- Responsible party
- Sponsor
- Investigators
- Bruce Wilkoff, MD, Principal investigator, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03772704
- Sponsor's protocol ID
- 18-1480
- Acronym
- MILES
- Status last verified
- Nov 2020
- First submitted
- 7 Dec 2018
- Last updated
- 18 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Patel D, Vatterott P, Piccini J, Epstein LM, Hakmi S, Syed I, Koweek LM, Bolen M, Schoenhagen P, Tarakji KG, Francis N, Shao M, Wilkoff BL. Prospective Evaluation of the Correlation Between Gated Cardiac Computed Tomography Detected Vascular Fibrosis and Ease of Transvenous Lead Extraction. Circ Arrhythm Electrophysiol. 2022 Nov;15(11):e010779. doi: 10.1161/CIRCEP.121.010779. Epub 2022 Oct 28.
PubMed 36306341
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Imaging in Lead Extraction Study
- ClinicalTrials.gov ID
- NCT03772704
- Acronym / sponsor ID
- MILES / 18-1480
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- The Cleveland ClinicUniversity, hospital or other
- Collaborators
- Philips Healthcare
- Study start
- 13 Dec 2018 (actual)
- Primary completion
- 4 Nov 2020 (actual)
- Study completion
- 4 Nov 2020 (actual)
- First posted
- 11 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objectives of this registry is to correlate the amount of fibrosis as documented on Electrocardiogram (ECG) gated Computed Tomography (CT) scans with ease of advancing sheaths over the leads through the SVC zone during lead extraction.
Detailed description
This is a multi-center, prospective, observational registry study which plans to enroll approximately 200 patients referred for Cardiac Implantable Electronic Device(CIED) lead extraction at one of the five study centers. The objective of this study is to determine whether a correlation exists between fibrosis detected on ECG gated cardiac CT and the ease of lead extraction as measured by need for extraction energy. All patients will be followed for 30 days post-lead extraction to assess vital status and re-hospitalizations via phone call
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 30 Days
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Referred patients for CIED lead extraction
Key inclusion criteria (3 listed)
- Referred for CIED (Cardiac Implantable Electronic Device) lead extraction with at least 1 lead with dwell time greater than one year
- ≥ 18 years of age
- Appropriate candidate for chest/cardiac CT with contrast and full lead analysis
Key exclusion criteria (1 listed)
- Atrial fibrillation with uncontrolled rate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Correlation of the presence and degree of fibrosis as determined by ECG gated cardiac CT with the presence and degree of fibrosis determined by ease of extraction sheath advancement
Time frame: 30 days
The presence and degree of fibrosis determined by the ease of extraction sheath advancement will be evaluated in three zones. Zone 1 will be the area before the Superior Vena Cava (SVC), Zone 2 in the SVC and Zone 3 after the SVC
8 secondary outcomes
Percentage of ECG gated CT scans that show fibrosis
Time frame: 30 days
Major complications as defined by Heart Rhythm Society (HRS) 2017 consensus guidelines
Time frame: 30 days
Minor complications as defined by HRS 2017 consensus guidelines
Time frame: 30 days
Mortality
Time frame: 30 days
Procedural outcomes
Time frame: 30 days
Fluoroscopy time
Time frame: 30 days
Pathological reports from extracted leads
Time frame: 30 days
Hospitalizations directly related to the extraction of leads or procedure related
Time frame: 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2020.
- Derived from this study: PubMed 36306341Patel D, Vatterott P, Piccini J, Epstein LM, Hakmi S, Syed I, Koweek LM, Bolen M, Schoenhagen P, Tarakji KG, Francis N, Shao M, Wilkoff BL. Prospective Evaluation of the Correlation Between Gated Cardiac Computed Tomography Detected Vascular Fibrosis and Ease of Transvenous Lead Extraction. Circ Arrhythm Electrophysiol. 2022 Nov;15(11):e010779. doi: 10.1161/CIRCEP.121.010779. Epub 2022 Oct 28.
- Individual participant dataSharing planned: No
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.
Bruce Wilkoff, MD principal investigator
The Cleveland Clinic
5 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mechanical Complication of Cardiac Electronic Device, run by The Cleveland Clinic at 5 sites in 2 countries.
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 3 inclusion and 1 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 18 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States, Germany. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Correlation of the presence and degree of fibrosis as determined by ECG gated cardiac CT with the presence and degree of fibrosis determined by ease of extraction sheath advancement (time frame: 30 days). 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 NCT03772704, which also lists 1 linked publication.
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 18 Nov 2020.