Complications of a Stepwise Approach for Transvenous Lead Extraction
Challenges and Complications of a Stepwise Approach for Transvenous Lead Extraction, Single High-Volume Center Study
1 other identifier
observational
100
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Mar 2020
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 29, 2020
CompletedStudy Start
First participant enrolled
March 1, 2020
CompletedFirst Posted
Study publicly available on registry
March 13, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2021
CompletedMarch 13, 2020
March 1, 2020
1 year
February 29, 2020
March 10, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Procedural related major complications
Complications includes pericardial effusion/tamponade, arrhythmia, hypotension, pulmonary embolism and death
one year
Secondary Outcomes (1)
Clinical and radiological success
3 months
Interventions
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
Eligibility Criteria
All ages and genders indicated for the procedure are recruited and all patient clinical background, morbidity and pacemaker related data will be collected
You may qualify if:
- 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.
You may not qualify if:
- Patients primarily requiring surgical extraction
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Brescia university hospital
Brescia, Italy
Related Publications (2)
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.
PMID: 21907423BACKGROUNDBontempi 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.
PMID: 28063271BACKGROUND
Study Officials
- PRINCIPAL INVESTIGATOR
Antonio Curnis
Assiut University
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- OTHER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant lecturer
Study Record Dates
First Submitted
February 29, 2020
First Posted
March 13, 2020
Study Start
March 1, 2020
Primary Completion
March 1, 2021
Study Completion
August 1, 2021
Last Updated
March 13, 2020
Record last verified: 2020-03