Complications of a Stepwise Approach for Transvenous Lead... | NCT04306575

Studies
Complications of a Stepwise Approach for Transvenous Lead Extraction

NCT04306575

Sponsor

Assiut University

Status

Unknown status

Last Update Posted

Mar 13, 2020Actual

Enrollment

100Estimated

Phase

Not provided

Conditions

Pacemaker Lead Dysfunction

Interventions

Trans-venous lead extraction

Countries

Italy

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2020

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2020Estimated

Primary Completion Date

Mar 2021Estimated

Completion Date

Aug 2021Estimated

First Submitted Date

Feb 29, 2020

First Submission Date that Met QC Criteria

Mar 10, 2020

First Posted Date

Mar 13, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 10, 2020

Last Update Posted Date

Mar 13, 2020Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Mohamed Aboelhassan Abdelrady Mohamed, Assistant lecturer, Assiut UniversityPrincipal Investigator

Lead Sponsor

Assiut UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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)

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Trans-venous lead extraction	Other	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

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Procedural related major complications	Complications includes pericardial effusion/tamponade, arrhythmia, hypotension, pulmonary embolism and death	one year

Secondary Outcomes

Measure	Description	Time Frame
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	3 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

Patients primarily requiring surgical extraction

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder 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

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Mohamed A Abdelrady	Contact	0020102201284		mabolhassan10@gmail.com

Overall Officials

Name	Affiliation	Role
Antonio Curnis	Assiut University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Brescia university hospital		Brescia			Italy

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
21907423	Background	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.
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