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

NCT02482844 | Unknown Phase 4

• 2 other identifiers: CHU-02392015-A00271-48
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Post-TAVI

Keywords

TAVI; de novo and persistent LBBB; electrophysiology; Holter; pacemaker

Outcome Measures

Primary Outcomes (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.

  at 12 months

Secondary Outcomes (4)

• 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

• 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

• 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

• 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

Study Arms (2)

Pacemaker

OTHER

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

OTHER

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

Interventions

pacemaker implantation OTHER

Pacemaker

holter implantation OTHER

holter implantable

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Patient with a pacemaker pre-TAVI
• Patient with LBBB pre-procedure
• Pregnancy
• Permanent atrial fibrillation

Sponsors & Collaborators

• University Hospital, Clermont-Ferrand: lead
• LivaNova: collaborator
• Biotronik France: collaborator

Study Sites (1)

Chu Clermont-Ferrand

Clermont-Ferrand, 63003, France

RECRUITING

Related Publications (1)

• 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.

  PMID: 27797979 DERIVED

Study Officials

• Romain ESCHALIER

  University Hospital, Clermont-Ferrand

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Patrick LACARIN

CONTACT

04 73 75 11 95; placarin@chu-clermontferrand.fr

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 18, 2015
• First Posted: June 26, 2015
• Study Start: June 1, 2015
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2017
• Last Updated: July 26, 2016

Record last verified: 2016-07

Locations

FR (1)