Assessment of the Prognosis of Persistent Left Bundle Branch Block (LBBB)After Transcatheter Aortic Valve Implantation (TAVI ) by an Electrophysiological and Remote Monitoring Risk-adapted Algorithm

Post-TAVI Clinical Trial

— LBBB-TAVI  

Official title:

Assessment of the Prognosis of Persistent Left Bundle Branch Block (LBBB) After Transcatheter Aortic Valve Implantation (TAVI ) by an Electrophysiological and Remote Monitoring Risk-adapted Algorithm

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02482844
• Other study ID #: CHU-0239
• Secondary ID: 2015-A00271-48
• Status: Recruiting
• Phase: Phase 4
• First received: June 18, 2015
• Last updated: July 25, 2016
• Start date: June 2015
• Est. completion date: December 2017

Study information

• Verified date: July 2016
• Source: University Hospital, Clermont-Ferrand
• Contact: Patrick LACARIN
• Phone: 04 73 75 11 95
• Email: placarin[@]chu-clermontferrand.fr
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Interventional

Clinical Trial Summary

The replacement of the aortic valve by percutaneous approach (called TAVI) is a therapy which is booming in the management of aortic stenosis. It concerns patients who have a high surgical risk presenting comorbidity, for whom a classic approach by surgery of valvular replacement seems unreasonable. Beyond its feasibility, the implantation of a TAVI is less invasive and improves the patient's morbi-mortality. The appearance of a Left Bundle Branch Block (LBBB) is one of the most frequent complications of this procedure and represents an important risk of atrio-ventricular (AV) high grade conductive disorders requiring permanent pacing in 5 in 15 % of the cases in 1 year.

De novo LBBB is associated with a more important morbi-mortality in post-TAVI situation. However, there are no predictive elements of these conductive disorders. Besides, the incidence and the deadline of appearance of this AV disorders are not established. It seems relevant to propose a new stratification based on ECG and endocavitary data. The monitoring of the conductive disorders is allowed by remote monitoring thanks to the implantation of a pacemaker or an implantable holter allowing to determine the incidence and the deadline of appearance of high grade AV conduction disorders.

Description:

The aim of this protocol is to study the appearance of the high grade AV conductive disorders at 12 months by monitoring for patients with a de novo LBBB after TAVI from an adapated algorithm to the risk and based on an early electrophysiological evaluation.

The recruitment of patients takes place in each cardiology department. The project is submitted to the Ethics Committee .

The patients are informed about this study by the investigator. After a reflection period and an answer to the possible questions, the patient is included. The informed consent is signed.

Every patient included with a de novo LBBB, persistent that is observed beyond 24 hours after the TAVI procedure, will benefit from an endocavitary electrophysiological exploration . According to the meditative delay of conduction, a pacemaker will be implanted in case of delay lengthened HV (> 70 ms) or of infrahissian block, in the opposite case the implantation of an holter with remote monitoring will be made.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 2017
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients over 18 year's old

• Patient implanted by a percutaneous biological aortic valve according to the recommendations of the European society of cardiology according to the guidelines of ESC 2012

• Life expectancy upper 1-year-old

• Sinusal rhythm

• Patient with a de novo LBBB post-TAVI persitent and observed beyond 24 hours after the procedure of TAVI.

Exclusion Criteria:

• Patient with a pacemaker pre-TAVI

• Patient with LBBB pre-procedure

• Pregnancy

• Permanent atrial fibrillation

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Bundle-Branch Block
• Post-TAVI

Intervention

Other:
• pacemaker implantation

• holter implantation

Locations

Country	Name	City	State
France	Chu Clermont-Ferrand	Clermont-Ferrand

Sponsors (3)

Lead Sponsor	Collaborator
University Hospital, Clermont-Ferrand	Biotronik France, LivaNova

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To assess the aAppearance (rate and deadlinetime after TAVI) of AV high-grade conductive disorders (complete AV block and AV block II Mobitz 2) in patients with de novo LBBB induced by TAVI.		at 12 months	Yes
Secondary	To assess the appearance (rate and time after TAVI) of AV high-grade conductive disorders (complete AV block and AV block II Mobitz 2) in patients with de novo LBBB induced by TAVI		at 3 months and at 6 months	Yes
Secondary	To identify predictive factors of AV high-grade conductive disorders in patients with de novo LBBB induced by TAVI		at 3 months, 6 months and 12 months	Yes
Secondary	To assess impact of de novo LBBB induced by TAVI on mortality (cardiovascular, heart failure, all causes) and hospitalizations (cardiovascular, heart failure, all causes)		at 3 months, 6 months and 12 months	Yes
Secondary	To assess safety (adverse events) of proposed management (endocardial electrophysiological study, permanent pacemaker implantation) in such patients		at 3 months, 6 months and 12 months	Yes