A comparison of traditional pacemaker systems, and the novel leadless pacing therapy in patients who develop heartrhythm disorders as a consequence of transcatheter aortic valve replacement.

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON29454

Enrollment

210

Registered

2017-10-04

Start date

2017-12-01

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Transcatheter Aortic Valve Replacement Leadless Pacemaker Pacing therapy Conduction disturbances

Interventions

1) Interventional arm: implant of LP therapy in TAVI-patients who are indicated for temporary pacing therapy post-TAVI implantation. 2) Control arm: standard pacemaker therapy in TAVI-patients who ar

Eligibility

Inclusion criteria

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

Exclusion criteria

Exclusion criteria: A potential subject who meets any of the following criteria will be excluded from participation in this study: -Patients with pre-existing pacing or defibrillation leads  -Patients with current ICD implant -Patients with current pacemaker implant -Patients unable to complete a questionnaire. -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 -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 6 12 hours after randomization with a leadless pacemaker due to any logistical issues

Design outcomes

Primary

Measure	Time frame
Difference in intervention-related complications	—

Secondary

Measure	Time frame
All-cause mortality Cardiovascular mortality Sudden cardiac death (SCD) Unexpected mortality (composite of sudden cardiac or unknown mortality) Composite of all-cause mortality and intervention-related complications Major Adverse Cardiac Event Stroke ischemic or hemorrhagic: classified as disabling or nondisabling TIA Intervention-related complications individually, defined in 6.4.1 Functional Improvement from baseline per NYHA functional classification Left ventricular function (in left ventricular ejection fraction [LVEF]) Length of in-hospital stay from randomization to discharge Time to mobilization Recurrent hospitalization due to cardiovascular event Total hospital days from the index procedure to one-year post procedure Composite of all-cause mortality, MACE, recurrent hospitalization for cardiovascular event Health Related Quality of Life Cost-effectiveness % PPM implantation in TV-TP group % Pacing in all pacemaker patients Patient satisfaction	—

Measure

Time frame

All-cause mortality Cardiovascular mortality Sudden cardiac death (SCD) Unexpected mortality (composite of sudden cardiac or unknown mortality) Composite of all-cause mortality and intervention-related complications Major Adverse Cardiac Event Stroke ischemic or hemorrhagic: classified as disabling or nondisabling TIA Intervention-related complications individually, defined in 6.4.1 Functional Improvement from baseline per NYHA functional classification Left ventricular function (in left ventricular ejection fraction [LVEF]) Length of in-hospital stay from randomization to discharge Time to mobilization Recurrent hospitalization due to cardiovascular event Total hospital days from the index procedure to one-year post procedure Composite of all-cause mortality, MACE, recurrent hospitalization for cardiovascular event Health Related Quality of Life Cost-effectiveness % PPM implantation in TV-TP group % Pacing in all pacemaker patients Patient satisfaction

—

Contacts

Public ContactNiek E.G. Beurskens

AMC Heart Center , Department of Cardiology, Academic Medical Center

n.e.beurskens@amc.nl+3120 5665550

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)