Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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 (LBBB-TAVI)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02482844
Recruitment Status : Unknown
Verified July 2016 by University Hospital, Clermont-Ferrand.
Recruitment status was:  Recruiting
First Posted : June 26, 2015
Last Update Posted : July 26, 2016
Sponsor:
Collaborators:
LivaNova
Biotronik France
Information provided by (Responsible Party):
University Hospital, Clermont-Ferrand

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.


Condition or disease Intervention/treatment Phase
Post-TAVI Other: pacemaker implantation Other: holter implantation Phase 4

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.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
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 Start Date : June 2015
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Pacemaker
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, we shall hold the setting-up of a pacemaker 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
Other: pacemaker implantation
holter implantable
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, we shall hold the setting-up of a pacemaker 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
Other: holter implantation



Primary Outcome Measures :
  1. 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. [ Time Frame: at 12 months ]

Secondary Outcome Measures :
  1. 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 [ Time Frame: at 3 months and at 6 months ]
  2. To identify predictive factors of AV high-grade conductive disorders in patients with de novo LBBB induced by TAVI [ Time Frame: at 3 months, 6 months and 12 months ]
  3. To assess impact of de novo LBBB induced by TAVI on mortality (cardiovascular, heart failure, all causes) and hospitalizations (cardiovascular, heart failure, all causes) [ Time Frame: at 3 months, 6 months and 12 months ]
  4. To assess safety (adverse events) of proposed management (endocardial electrophysiological study, permanent pacemaker implantation) in such patients [ Time Frame: at 3 months, 6 months and 12 months ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02482844


Contacts
Layout table for location contacts
Contact: Patrick LACARIN 04 73 75 11 95 placarin@chu-clermontferrand.fr

Locations
Layout table for location information
France
Chu Clermont-Ferrand Recruiting
Clermont-Ferrand, France, 63003
Contact: Patrick LACARIN    04 73 75 11 95    placarin@chu-clermontferrand.fr   
Principal Investigator: Romain ESCHALIER         
Sponsors and Collaborators
University Hospital, Clermont-Ferrand
LivaNova
Biotronik France
Investigators
Layout table for investigator information
Principal Investigator: Romain ESCHALIER University Hospital, Clermont-Ferrand

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: University Hospital, Clermont-Ferrand
ClinicalTrials.gov Identifier: NCT02482844     History of Changes
Other Study ID Numbers: CHU-0239
2015-A00271-48 ( Registry Identifier: 2015-A00271-48 )
First Posted: June 26, 2015    Key Record Dates
Last Update Posted: July 26, 2016
Last Verified: July 2016
Keywords provided by University Hospital, Clermont-Ferrand:
TAVI
de novo and persistent LBBB
electrophysiology
Holter
pacemaker
Additional relevant MeSH terms:
Layout table for MeSH terms
Bundle-Branch Block
Heart Block
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Cardiac Conduction System Disease
Pathologic Processes