TLE: Contemporary Transvenous Lead Extraction Outcomes

• Sponsor: Deutsches Herzzentrum Muenchen (Other)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT05037474
• Collaborator: (none)
• Enrollment: 340
• Location: 1
• Anticipated Duration (Months): 33
• Patients Per Site Per Month: 10.3

Study Details

Study Description

Brief Summary

Presentation of procedural safety and outcomes data from a high volume TLE centre

Condition or Disease	Intervention/Treatment	Phase
Pacemaker Lead Dysfunction; Pacemaker Electrode Infection; ICD; Endocarditis Infective	Procedure: TLE group

Detailed Description

Transvenous lead extraction is crucial procedure in the longterm management of patients with implanted pacemakers or cardioverter defibrillators.

Our study presents the patient and procedural characteristics as well as the outcome data of a cohort undergoing transvenous lead extraction (TLE) with olny mechanical extraction tools at a high-volume TLE centre.

Study Design

• Study Type: Observational
• Actual Enrollment: 340 participants
• Observational Model: Cohort
• Time Perspective: Retrospective
• Official Title: Contemporary Mechanical Lead Extraction Outcomes From a High-volume Center: Patient Characteristics, Procedural Characteristics and Outcomes.
• Actual Study Start Date: Apr 1, 2020
• Actual Primary Completion Date: Oct 1, 2021
• Anticipated Study Completion Date: Dec 31, 2022

Outcome Measures

Primary Outcome Measures

1. Percentage of patients with complete or clinical successful lead removal [acute setting (during the surgical procedure)]

   Removal of a lead or retention of a part less than 4cm

2. Percentage of patients undergoing TLE with major and minor complication [acute setting (during the surgical procedure)]

   procedure related major and minor complications

Secondary Outcome Measures

1. long term outcome [>12months follow up]

   survival after TLE

2. Percentage of patients encountering a major or minor sedation complication during TLE [acute setting (during the surgical procedure)]

   Complication of cardiologist-directed sedation during TLE procedures

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• all patients undergoing a lead removal procedure

Exclusion Criteria:

• minors

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Deutsches Herzzentrum München	Munich	Bayern	Germany	80636

Sponsors and Collaborators

• Deutsches Herzzentrum Muenchen

Investigators

• Principal Investigator: Carsten Lennerz, MD, German Heart Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Deutsches Herzzentrum Muenchen
• ClinicalTrials.gov Identifier: NCT05037474
• Other Study ID Numbers: GER-EP-025
• First Posted: Sep 8, 2021
• Last Update Posted: May 6, 2022
• Last Verified: Aug 1, 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Endocarditis, Bacterial; Endocarditis

Study Results

No Results Posted as of May 6, 2022