The PACE NOW Trial: A Prospective, rAndomized Comparison of tEmporary transvenous pacing and leadless paciNg therapy in pOst-TAVI patients With conduction abnormalities

Phase 3

Completed

• Conditions: abnormal heart rhythm; Conduction abnormalities; 10007521

• Registration Number: NL-OMON44244
• Lead Sponsor: Academisch Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 28 February 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 150

Inclusion Criteria

- Patients * 18 years
- TAVI patients that have a need for temporary pacing therapy, defined as:
1) intra-procedural or post-procedural (up to 48 hours) high degree AV block
2) intra-procedural or post-procedural (up to 48 hours) (sinus) bradycardia
3) intra-procedural or post-procedural (up to 48 hours) new onset of 1st degree AV block,
RBBB, LBBB

Exclusion Criteria

-Patients with pre-existing pacing or defibrillation leads
-Patients with current ICD implant
-Patients with current pacemaker implant
-Patients with pacemaker syndrome, has retrograde AV conduction, or suffers a drop in arterial blood pressure with the onset of ventricular pacing apart from rapid pacing during the TAVI implant procedure*
-Patients who are allergic or hypersensitive to <1mg of dexamethasone sodium phosphate (DSP)*
-Patients with a mechanical tricuspid valve prosthesis
-Patients with implanted vena cava filter
-Patients with a serious known concomitant disease with a life expectancy of less than one year
-Patients with a cardiac contractility modulator
-Patients with circumstances that prevent follow-up
-Patients who are unable to give informed consent
-Patents who cannot be implanted within 12 hours after randomization with a leadless pacemaker due to any logistical issues

Study & Design

• Study Type: Interventional
• Study Design: Not specified