Pacemaker Lead DysfunctionNCT04306575
Complications of a Stepwise Approach for Transvenous Lead Extraction
An observational study of Pacemaker Lead Dysfunction, run by Assiut University at 1 site in Italy.
Trial summary
It is an observational study of predictors of complications and difficulty of trans-venous lead extraction procedure. This procedure is done for patient who had a previous cardiac pacemaker or defibrillator implantation which had a dysfunction or infection so needed to be extracted. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Pacemaker Lead Dysfunction
- What is being tested?
- Trans-venous lead extraction
- How many people
- 100 participants
- Where
- 1 siteItaly
- Study dates
- Mar 2020to Aug 2021
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All ages and genders indicated for the procedure are recruited and all patient clinical background, morbidity and pacemaker related data will be collected
Who may be able to join
- All consecutive patients referred for lead extraction with class I and IIa indications according to 2017 HRS expert consensus statement on CIED lead management and extraction.
Who cannot join
- Patients primarily requiring surgical extraction
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Challenges and Complications of a Stepwise Approach for Transvenous Lead Extraction, Single High-Volume Center Study
It is an observational study of predictors of complications and difficulty of trans-venous lead extraction procedure. This procedure is done for patient who had a previous cardiac pacemaker or defibrillator implantation which had a dysfunction or infection so needed to be extracted.
Read the detailed description
The number of cardiac implantable electronic device (CIED) implantations has increased over recent years (1) with approximately 1.2-1.4 million CIEDs are being implanted annually worldwide.(2) Consequently this has been associated with increasing rates of infection and lead malfunctions, affecting approximately 1-2% of all CIED cases.(3)
Recently, it is estimated that between 10 000 and 15 000 leads are extracted worldwide each year.(4) Over the past few decades, transvenous lead extraction (TLE) has evolved as the preferred method for leads removal being less invasive compared to surgical removal by open heart surgery which is now reserved for cases with high risk procedures or a very large vegetation.
Most frequent indications for TLE are infection (accounting for 52.8%) and lead dysfunction (accounting for 38.1%) of all cases of TLE. (5)
There have been different approaches (superior and inferior approaches) and techniques for TLE. Current techniques employ mechanical and/or laser equipment with variable success rates. The locking stylet has been the principal tool in these techniques, while the telescoping (powered or non-powered) mechanical or laser sheaths serve as the most important ancillary tools.
Despite being a safe procedure with minor complications ranging from 0.06 to 6.2%, but serious complications may still arise in 0.2-1.8 % of cases in even the most experienced hands with mortality rates in several large registries amounting 0.2 - 1.2 %.(6) Although many studies have tried to identify risk factors for complications including patient/lead profile and centre/operator experience, major studies still have conflicting results.
Recently, the hybrid approach, with mini-thoracotomy or thoracoscopy, has been introduced and supposed to be associated with increased safety in challenging TLE procedures. (7, 8)
- Conditions
- Pacemaker Lead Dysfunction
- Being tested
- Trans-venous lead extraction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trans-venous lead extractionOther
Patients with a dysfunction or infection of a cardiac pacemaker or a defibrillator are indicated for extraction of these devices, so lead extraction is done transvenously to remove these leads
What is being measured
The primary outcome is the main question the study is designed to answer.
Procedural related major complications
Complications includes pericardial effusion/tamponade, arrhythmia, hypotension, pulmonary embolism and death
Measured: one year
Secondary outcomes (1)
Clinical and radiological success
clinical success means that the procedure completed with no procedural complications, Radiological success means complete extraction of the whole lead or remaining of less than 3 cm
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2020
- Study startMar 2020 (estimated)
- Primary completionMar 2021 (estimated)
- Study completionAug 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Pacemaker Lead DysfunctionStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe 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
- Other
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Aboelhassan Abdelrady Mohamed, Assiut University
- Investigators
- Antonio Curnis, Principal investigator, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04306575
- Sponsor's protocol ID
- 01020031284
- Status last verified
- Mar 2020
- First submitted
- 29 Feb 2020
- Last updated
- 13 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Curnis A, Bontempi L, Coppola G, Cerini M, Gennaro F, Vassanelli F, Lipari A, Ashofair N, Pagnoni C, Bisleri G, Munaretto C, Dei Cas L. Active-fixation coronary sinus pacing lead extraction: a hybrid approach. Int J Cardiol. 2012 May 3;156(3):e51-2. doi: 10.1016/j.ijcard.2011.08.016. Epub 2011 Sep 9. No abstract available.
PubMed 21907423Bontempi L, Vassanelli F, Cerini M, Bisleri G, Repossini A, Giroletti L, Inama L, Salghetti F, Liberto D, Giacopelli D, Raweh A, Muneretto C, Curnis A. Hybrid Minimally Invasive Approach for Transvenous Lead Extraction: A Feasible Technique in High-Risk Patients. J Cardiovasc Electrophysiol. 2017 Apr;28(4):466-473. doi: 10.1111/jce.13164. Epub 2017 Feb 9.
PubMed 28063271
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Challenges and Complications of a Stepwise Approach for Transvenous Lead Extraction, Single High-Volume Center Study
- ClinicalTrials.gov ID
- NCT04306575
- Acronym / sponsor ID
- 01020031284
- Conditions
- Pacemaker Lead Dysfunction
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Mar 2020 (estimated)
- Primary completion
- Mar 2021 (estimated)
- Study completion
- Aug 2021 (estimated)
- First posted
- 13 Mar 2020 (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.
It is an observational study of predictors of complications and difficulty of trans-venous lead extraction procedure. This procedure is done for patient who had a previous cardiac pacemaker or defibrillator implantation which had a dysfunction or infection so needed to be extracted.
Detailed description
The number of cardiac implantable electronic device (CIED) implantations has increased over recent years (1) with approximately 1.2-1.4 million CIEDs are being implanted annually worldwide.(2) Consequently this has been associated with increasing rates of infection and lead malfunctions, affecting approximately 1-2% of all CIED cases.(3)
Recently, it is estimated that between 10 000 and 15 000 leads are extracted worldwide each year.(4) Over the past few decades, transvenous lead extraction (TLE) has evolved as the preferred method for leads removal being less invasive compared to surgical removal by open heart surgery which is now reserved for cases with high risk procedures or a very large vegetation.
Most frequent indications for TLE are infection (accounting for 52.8%) and lead dysfunction (accounting for 38.1%) of all cases of TLE. (5)
There have been different approaches (superior and inferior approaches) and techniques for TLE. Current techniques employ mechanical and/or laser equipment with variable success rates. The locking stylet has been the principal tool in these techniques, while the telescoping (powered or non-powered) mechanical or laser sheaths serve as the most important ancillary tools.
Despite being a safe procedure with minor complications ranging from 0.06 to 6.2%, but serious complications may still arise in 0.2-1.8 % of cases in even the most experienced hands with mortality rates in several large registries amounting 0.2 - 1.2 %.(6) Although many studies have tried to identify risk factors for complications including patient/lead profile and centre/operator experience, major studies still have conflicting results.
Recently, the hybrid approach, with mini-thoracotomy or thoracoscopy, has been introduced and supposed to be associated with increased safety in challenging TLE procedures. (7, 8)
Study design
- Observational model
- Case only
- Time perspective
- Other
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All ages and genders indicated for the procedure are recruited and all patient clinical background, morbidity and pacemaker related data will be collected
Key inclusion criteria (1 listed)
- All consecutive patients referred for lead extraction with class I and IIa indications according to 2017 HRS expert consensus statement on CIED lead management and extraction.
Key exclusion criteria (1 listed)
- Patients primarily requiring surgical 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 |
|---|---|---|
| Trans-venous lead extractionPatients with a dysfunction or infection of a cardiac pacemaker or a defibrillator are indicated for extraction of these devices, so lead extraction is done transvenously to remove these leads | Other | – |
Primary outcome
Procedural related major complications
Time frame: one year
Complications includes pericardial effusion/tamponade, arrhythmia, hypotension, pulmonary embolism and death
1 secondary outcome
Clinical and radiological success
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2020.
- Background: PubMed 21907423Curnis A, Bontempi L, Coppola G, Cerini M, Gennaro F, Vassanelli F, Lipari A, Ashofair N, Pagnoni C, Bisleri G, Munaretto C, Dei Cas L. Active-fixation coronary sinus pacing lead extraction: a hybrid approach. Int J Cardiol. 2012 May 3;156(3):e51-2. doi: 10.1016/j.ijcard.2011.08.016. Epub 2011 Sep 9. No abstract available.
- Background: PubMed 28063271Bontempi L, Vassanelli F, Cerini M, Bisleri G, Repossini A, Giroletti L, Inama L, Salghetti F, Liberto D, Giacopelli D, Raweh A, Muneretto C, Curnis A. Hybrid Minimally Invasive Approach for Transvenous Lead Extraction: A Feasible Technique in High-Risk Patients. J Cardiovasc Electrophysiol. 2017 Apr;28(4):466-473. doi: 10.1111/jce.13164. Epub 2017 Feb 9.
- Individual participant dataSharing planned: Undecided
Related trials for Pacemaker Lead Dysfunction
Active, not recruitingObservational study
Safety, Performance, and Clinical Benefit of Pacing the Left Bundle Branch Area - Post-Market Clinical Follow-up
Bradycardia, Atrioventricular Block
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.
Antonio Curnis principal investigator
Assiut University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pacemaker Lead Dysfunction, run by Assiut University at 1 site in Italy.
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 1 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: status not confirmed, as of the sponsor's last update on 13 Mar 2020. 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 Italy. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mohamed A Abdelrady (0020102201284, mabolhassan10@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Procedural related major complications (time frame: one year). 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 NCT04306575, which also lists 2 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 13 Mar 2020.