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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.


- candidate number27981
- NTR NumberNTR6730
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR4-okt-2017
- Secondary IDsNL- 62264  METC Academisch Medisch Centrum te Amsterdam
- Public TitleA 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.
- Scientific TitleA Prospective, rAndomized Comparison of tEmporary transvenous pacing and leadless paciNg therapy in pOst-TAVI patients With conduction abnormalities
- ACRONYMthe PACE NOW trial
- hypothesis1. Leadless Pacemaker (LP) therapy is superior to current standard-of-care (SOC) with regard to procedure-related complications in Transcatheter Aortic Valve Replacement (TAVI) patients who develop conduction abnomalies (CA).
2. LP therapy reduces hospital admission, re-interventions and mortality compared to current SOC.
3. LP therapy has a positive impact on Health-Related Quality of Life, and patients satisfaction post-TAVI.
4. LP therapy is a cost-effective therapy in TAVI patients.
- Healt Condition(s) or Problem(s) studiedTranscatheter aortic valve replacement, Leadless pacemaker, Conduction disturbance
- 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 criteriaA 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
- mec approval receivedno
- multicenter trialyes
- randomisedyes
- masking/blindingDouble
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-dec-2017
- planned closingdate1-dec-2020
- Target number of participants210
- Interventions1) 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 are indicated for temporary pacing therapy post-TAVI implantation, and subsequent conventional transvenous permanent pacemaker therapy if applicable.
- Primary outcomeDifference in intervention-related complications
- Secondary outcomeAll-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
- TimepointsShort-term, and mid-term for primary and secondary endpoint
Possible outside scope of study long-term differences between arms.
- Trial web site
- statusplanned
- CONTACT FOR PUBLIC QUERIESMD Niek E.G. Beurskens
- CONTACT for SCIENTIFIC QUERIESMD Niek E.G. Beurskens
- Sponsor/Initiator Academic Medical Center
- Funding
(Source(s) of Monetary or Material Support)
Academic Medical Center (AMC)
- Publications
- Brief summaryIn 6-28% of patients undergoing transcatheter aortic valve implantation (TAVI), there is a need for temporary and subsequent permanent pacing therapy, and it is difficult to predict which patients will develop this need. Patients requiring transvenous temporary pacing (TV-TP) are mandated bed rest and therefore at risk for infections, cardiac perforation, lead malfunction, delirium, re-intervention and prolonged hospitalization. In up to 67% of these patients who received TV-TP the pacing need persists, hence requiring a second procedure, the implantation of a permanent pacemaker (PPM). Conventional PPM therapy has evolved substantially since its introduction, however reported serious adverse events rates are ∼20% at 5 years, with highest contributions related to the pacing lead (∼11%) and pocket (∼8%). Temporary and subsequent permanent transvenous pacing therapy complications can be reduced by replacing it with leadless pacemaker (LP) therapy, a recently introduced technology aimed to reduce complications related to conventional PPM. LP therapy enables the possibility to treat TAVI patients with conduction disturbances in a single procedure. Patients do not longer require TV-TP, and a second procedure because the LP serves as a permanent solution. This strategy has the potential to decrease the high complication rates in TV-TP, shorten hospital admissions, and provide permanent pacing with potentially lower complication rates than conventional transvenous PPM systems.
- Main changes (audit trail)
- RECORD4-okt-2017 - 28-okt-2017


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