Temporary Pacemaker in Transcatheter Aortic Valve Implantation Patients

NCT02768064 | Unknown

• 1 other identifier: 065015-HMO-CTIL
• Study Type: interventional
• Target: 120
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Aortic Stenosis

Outcome Measures

Primary Outcomes (7)

• Number of participants with pericardial effusion with or without tamponade

  Pericardial effusion estimated by echocardiography, will be done during the hospitalization. It will be described as minimal/mild/moderate/large

  1 week

• Number of participants with Electrode Dislocation

  Electrode Dislocation (sensing / pacing problems, requiring lead re-positioning). The dislocation will be diagnosed by chest X ray or by sensing / pacing parameters.

  1 week

• Number of participants with Bleeding complications

  Bleeding complications, described as local hematoma within the area of the electrode insertion, during the procedure or the hospitalization.

  1 week

• Number of participants with Infections complications

  Infections complications, described as fever above 38.0 celsius degree or positive blood culture during the hospitalization after the procedure.

  1 week

• Number of participants with access site complications

  Access site complications describe as perforation of near organs (jugular artery)

  1 week

• Number of participants with Pneumothorax

  Pneumothorax diagnosed by clinical examination and CXR within 3 days after the procedure.

  1 week

• Number of participants with pacemaker failure

  Rates of Pacing or sensing failure during the procedure, or the days after,

  1 week

Secondary Outcomes (7)

• An implantation of permanent pacemaker

  one year

• The time (in days) the patient was able to get down from his bed to a chair, after the procedure

  week

• The time (in days) the patients has stayed in Intensive Cardiac Care Unit

  2 weeks

• The Cost of Pacing equipment

  1 week

• The TAVI procedure time

  1 day

Study Arms (2)

Flexible screwed electrode

EXPERIMENTAL

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

Device: temporary pacemaker insertion

Stiff standard electrode

ACTIVE COMPARATOR

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

Device: temporary pacemaker insertion

Interventions

temporary pacemaker insertion DEVICE

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

Flexible screwed electrode; Stiff standard electrode

Eligibility Criteria

• Age: 60 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All TAVI patients

You may not qualify if:

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

Sponsors & Collaborators

• Hadassah Medical Organization: lead

Related Publications (3)

• 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.

  PMID: 22749306 BACKGROUND

• 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.

  PMID: 23597613 BACKGROUND

• 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.

  PMID: 23257375 BACKGROUND

MeSH Terms

Conditions

Aortic Valve Stenosis

Condition Hierarchy (Ancestors)

Aortic Valve Disease; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Ventricular Outflow Obstruction

Study Officials

• Amir Orlev, Dr

  Hadassah Medical Organization

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Amir Orlev, Dr

CONTACT

972-2-6776564; amir.orlev@gmail.com

David Luria, Dr

CONTACT

972-2-6776564; dluria33@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: February 10, 2016
• First Posted: May 11, 2016
• Study Start: June 1, 2016
• Primary Completion: January 1, 2018
• Study Completion: December 1, 2018
• Last Updated: May 11, 2016

Record last verified: 2016-05

Data Sharing

• IPD Sharing: Will not share