Temporary Pacemaker in Transcatheter Aortic Valve Implantation Patients

NCT ID: NCT02768064

Last Updated: 2016-05-11

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-06-30
• Study Completion Date: 2018-12-31

Brief Summary

During Transcatheter aortic valve implantation (TAVI) procedure, a new valve is implanted. The valve can be CoreValve (Medtronic Company) or Edward SAPIENS (Edwards Company).

All TAVI patients require a temporary pacemaker(PMK), which is usually performed by insertion of a standard temporary electrode through the femoral vein. The temporary PMK is associated with a small but significant rate of complications.

The PMK is usually removed immediately at the end of the TAVI procedure, only when using the Edward SAPIENS valve. The CoreValve valve is more associated with conduction complications, and thus the PMK is later removed in these cases.

PMK Complications seen include:

• Right Ventricle perforation by temporary electrode, leading to Pericardial bleeding, in some cases with Tamponade
• Infection
• Electrode dislocation causing In-effective pacing (and/or sensing)
• Prolonged bed rest
• Prolonged hospitalization
• Access related problems (hematoma, pneumothorax) In a review of a large cohort (1) of patients from Milan (JACC 2012) the rate of tamponade was 4.3% most of which was associated with the temporary PMK.

Detailed Description

The investigators had experienced not infrequent occurrences of temporary electrode associated tamponade, either acutely after Transcatheter aortic valve implantation (TAVI) completion, or delayed, in association with the electrode removal.

The tamponade rate in patients with a temporary pacemaker(PMK) was 14/150 (9.3%). Not all tamponade cases were related to the temporary PMK, 2 occurred in the setting of catastrophic annular rupture and one of the first cases was related to the Left Ventricle stiff wire.

The investigators also noted a significant prolongation of bed rest and hospital stay in patients with temporary PMK.

Using a flexible permanent pacing electrode which is actively fixed to the Right Ventricle and is placed through the jugular vein will reduce pacing-related complication rates (due to the flexibility of the electrode), time to ambulation (due to the fixation of the electrode), hospital stay and also unnecessary PMK. Cost will also be reduced due to prevention of complications and reduction in Intensive Cardiac Care Unit time.

Procedure time might be slightly prolonged since the placement of the standard electrode is more timely, however this prolongation is negligible, and the benefits of the flexible permanent pacing electrode are worth this prolongation

Conditions

Aortic Stenosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Flexible screwed electrode

In the TAVI patients, during the intervention procedure, a temporary pacemaker will be implanted, using a flexible screwed electrode.

Group Type: EXPERIMENTAL

temporary pacemaker insertion

Intervention Type: DEVICE

Insertion of pacemaker electrode (Medtronic flow direct pacing catheter), connect to external pacemaker (Medtronic).

Stiff standard electrode

In the TAVI patients, during the intervention procedure, a temporary pacemaker will be implanted, using a stiff standard temporary electrode

Group Type: ACTIVE_COMPARATOR

temporary pacemaker insertion

Intervention Type: DEVICE

Insertion of pacemaker electrode (Medtronic flow direct pacing catheter), connect to external pacemaker (Medtronic).

Interventions

temporary pacemaker insertion

Insertion of pacemaker electrode (Medtronic flow direct pacing catheter), connect to external pacemaker (Medtronic).

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• All TAVI patients

Exclusion Criteria

• Existing contraindication for either femoral or jugular venous access
• Refused informed consent
• Permanent PMK
• Platelets count less than 50 K.

• Minimum Eligible Age: 60 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hadassah Medical Organization

OTHER

Sponsor Role: lead

Responsible Party

Orlev Amir

Dr

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Amir Orlev, Dr

Role: PRINCIPAL_INVESTIGATOR

Hadassah Medical Organization

Central Contacts

Amir Orlev, Dr

Role: CONTACT

amir.orlev@gmail.com

972-2-6776564

David Luria, Dr

Role: CONTACT

dluria33@gmail.com

972-2-6776564

References

Webb JG, Wood DA. Current status of transcatheter aortic valve replacement. J Am Coll Cardiol. 2012 Aug 7;60(6):483-92. doi: 10.1016/j.jacc.2012.01.071. Epub 2012 Jun 27.

Reference Type: BACKGROUND

PMID: 22749306 (View on PubMed)

Barbash IM, Waksman R, Pichard AD. Prevention of right ventricular perforation due to temporary pacemaker lead during transcatheter aortic valve replacement. JACC Cardiovasc Interv. 2013 Apr;6(4):427. doi: 10.1016/j.jcin.2013.01.135. No abstract available.

Reference Type: BACKGROUND

PMID: 23597613 (View on PubMed)

Rezq A, Basavarajaiah S, Latib A, Takagi K, Hasegawa T, Figini F, Cioni M, Franco A, Montorfano M, Chieffo A, Maisano F, Corvaja N, Alfieri O, Colombo A. Incidence, management, and outcomes of cardiac tamponade during transcatheter aortic valve implantation: a single-center study. JACC Cardiovasc Interv. 2012 Dec;5(12):1264-72. doi: 10.1016/j.jcin.2012.08.012.

Reference Type: BACKGROUND

PMID: 23257375 (View on PubMed)

Other Identifiers

065015-HMO-CTIL

Identifier Type: -

Identifier Source: org_study_id