Clinical trial NCT02482844: 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
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Post-TAVI
Keywords: TAVI
de novo and persistent LBBB
electrophysiology
Holter
pacemaker
Lead sponsor: University Hospital, Clermont-Ferrand
Sponsor class: OTHER
Collaborators: name: LivaNova
name: Biotronik France
First posted: 2015-06-26
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: 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.
timeFrame: at 12 months
Secondary outcomes:
measure: 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
timeFrame: at 3 months and at 6 months
measure: To identify predictive factors of AV high-grade conductive disorders in patients with de novo LBBB induced by TAVI
timeFrame: at 3 months, 6 months and 12 months
measure: To assess impact of de novo LBBB induced by TAVI on mortality (cardiovascular, heart failure, all causes) and hospitalizations (cardiovascular, heart failure, all causes)
timeFrame: at 3 months, 6 months and 12 months
measure: To assess safety (adverse events) of proposed management (endocardial electrophysiological study, permanent pacemaker implantation) in such patients
timeFrame: at 3 months, 6 months and 12 months
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: Chu Clermont-Ferrand
Study officials:
affiliation: University Hospital, Clermont-Ferrand
name: Romain ESCHALIER
role: PRINCIPAL_INVESTIGATOR
References:
citation: Massoullie G, Bordachar P, Irles D, Caussin C, Da Costa A, Defaye P, Jean F, Mechulan A, Mondoly P, Souteyrand G, Pereira B, Ploux S, Eschalier R. Prognosis assessment of persistent left bundle branch block after TAVI by an electrophysiological and remote monitoring risk-adapted algorithm: rationale and design of the multicentre LBBB-TAVI Study. BMJ Open. 2016 Oct 26;6(10):e010485. doi: 10.1136/bmjopen-2015-010485.