Indication of Permanent Cardiac Parcing After Tanscatheter Aortic Valve Implantation

NCT02337140 | Completed

• 1 other identifier: 9357
• Study Type: interventional
• Target: 165
• Locations: 1 country
• Sites: 1

Brief Summary

Since 2002, transcatheter aortic valve implantation (TAVI) has resulted in a dramatic change in the prognosis of patients with aortic valve stenosis illegible to surgery. However, this intervention may induce heavy conduction disorder due to the proximity of the aortic annulus and the conduction pathways. So far, there is no clear recommandation for clinical management of conduction disorder after TAVI. Standard criterion cannot be applied due to the multiple comorbidity factors observed in these patients. As described in conventional aortic valve surgery, a degree of inflammation and ischemia of the conduction pathways may be involved in the first days. This is the reason underlying the systematic implantation of epicardial electrodes. Such temporary back-up pacing is not possible in TAVI patients. The primary end-point of this study is to confirm that standard criterion for pacing are reliable in post-TAVI conduction disorders and to analyze the contribution of a systematic electrophysiological study (EPS). In TAVI patients, indications for pacing were persistent high-degree atrioventricular block (AVB) or bundle branch block appearance associated to HV interval longer than 70ms, 24 hours after the procedure. After a two-month follow-up, clinical and ECG evaluation and 24-hour holter monitoring will be realized in patients without pacemaker and compared to data obtained from the devices in pacemaker-implanted patients (% of ventricular pacing \> 1% ; presence of more than 1 AVB episod).

Conditions

Aortic Valve Stenosis

Keywords

TAVI; complete AV-block; HV-interval; permanent pacemaker; valve implantation; severe; conduction; disorders

Outcome Measures

Primary Outcomes (1)

• to confirm appropriate pacing indication in patients with conduction disorders after TAVI

  Pacemaker implantation will be confirmed if there is more than 1% of ventricular pacing or at least one DDD mode switch in the memories. In non-implanted patients, the non-indication for pacing was confirmed in the absence of clinical event and 24-hour Holter ECG recording abnormality.

  2 months

Secondary Outcomes (10)

• Measures electrocardiographic characteristics before and after implantation

  2 months

• Measures echographic characteristics

  2 months

• Type of bioprosthesis

  2 months

• Positioning bioprosthesis

  2 months

• Diameter of the implanted bioprosthesis and ratio with the surface of the patient's aortic valve

  2 months

Study Arms (2)

Pacemaker

EXPERIMENTAL

Patient who have been implanted with a pacemaker after TAVI

Device: Pacemaker SORIN Group KORA DR; Procedure: transcatheter aortic valve implantation (TAVI)

No Pacemaker

ACTIVE COMPARATOR

Patient who have not been implanted with a pacemaker after TAVI

Procedure: transcatheter aortic valve implantation (TAVI)

Interventions

Pacemaker SORIN Group KORA DR DEVICE

Pacemaker

transcatheter aortic valve implantation (TAVI) PROCEDURE

No Pacemaker; Pacemaker

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patient undergoing TAVI through femoral approach
• age \> 50 years
• informed and written consent
• patient with social security system

You may not qualify if:

• patient with previous pacemaker or ICD
• patient under guardianship or curatorship
• patient protected by law

Sponsors & Collaborators

• University Hospital, Montpellier: lead

Study Sites (1)

University Hospital Arnaud de Villeneuve

Montpellier, 34295, France

Location

MeSH Terms

Conditions

Aortic Valve Stenosis; Lymphoma, Follicular; Disease

Interventions

Transcatheter Aortic Valve Replacement

Condition Hierarchy (Ancestors)

Aortic Valve Disease; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Ventricular Outflow Obstruction; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Heart Valve Prosthesis Implantation; Cardiac Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Prosthesis Implantation; Thoracic Surgical Procedures

Study Officials

• THOMANN SARAH, MD

  University Hospital, Montpellier France

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 11, 2014
• First Posted: January 13, 2015
• Study Start: August 1, 2014
• Primary Completion: April 1, 2016
• Study Completion: August 1, 2016
• Last Updated: December 1, 2016

Record last verified: 2016-11

Locations

FR (1)