Temporary Pacemaker in Transcatheter Aortic Valve Implantation Patients (PAMIT)

Hadassah Medical Center

Status: Unknown

Conditions: Aortic Stenosis

Treatments: Device: temporary pacemaker insertion

Study type: Interventional

Funder types: Other

Identifiers

NCT02768064

065015-HMO-CTIL

Details and patient eligibility

About

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.

Full 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

Enrollment: 120 estimated patients

Sex: All

Ages: 60 to 100 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 2 patient groups

Flexible screwed electrode

Experimental group

Description:

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

Treatment:

Device: temporary pacemaker insertion

Stiff standard electrode

Active Comparator group

Description:

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

Treatment:

Device: temporary pacemaker insertion