Clinical trial NCT01528657: Ventricular Pace Suppression Versus Intrinsic Rhythm Support Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sick Sinus Syndrome
Keywords: Sick Sinus Syndrome
Ventricular pacing
Minimal ventricular pacing
Ventricular pacing suppression
Intrinsic rhythm support
Long term AV
Lead sponsor: Biotronik SE & Co. KG
Sponsor class: INDUSTRY
First posted: 2012-02-08
Enrollment: 230
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The objective of this study is to intra-individually compare the performances of two pacemaker algorithms designed to reduce unnecessary right ventricular pacing: Intrinsic Rhythm Support Plus (IRSplus) and Ventricular Pace Suppression (VpS). The study will compare ventricular pacing percentage, long-term atrio-ventricular conduction time, occurrences of atrial tachyarrhythmic events and atrial fibrillation burden percentage in patients implanted with a pacemaker for Sick Sinus Syndrome.


Eligibility criteria: Inclusion Criteria:

* Patients over 18 years of age;
* Patient has proven informed consent;
* Subject with indication of dual chamber pacemaker due to Sinus Node Dysfunction;
* Subjects with a dual chamber pacemaker already implanted within six months from enrollment, provided that ventricular pacing percentage ≤ 40% and with the right ventricular lead in the apical position;
* Stable medical situation;
* Stable geographical situation;

Exclusion Criteria:

* Permanent or paroxysmal AV block ≥ II;
* Permanent Atrial fibrillation/Atrial flutter;
* Device Replacement;
* Patient with a poor echocardiographic window;
* Patient already implanted with the right ventricular lead not in the apical position;
* Subjects with a dual chamber pacemaker, implanted later than six months;
* Subjects with a dual chamber pacemaker with ventricular pacing percentage ≥ 40%;
* Contraindication for DDD(R)-ADI(R) or DDD(R) pacing modes;
* VpS or IRSplus algorithm contraindications;
* Age \< 18 years;
* Life expectancy \< 12 months;
* Cardiac surgery planned within the FU period;
* Participation to another clinical investigation;

Primary outcomes:
measure: Ventricular pacing percentage
timeFrame: 6 months
Secondary outcomes:
measure: Long-term atrio-ventricular conduction delay
timeFrame: 6 Months
measure: Occurrence of atrial tachycardia or atrial fibrillation events
timeFrame: 6 Months
measure: Burden of atrial fibrillation
timeFrame: 6 Months
Other outcomes:
Locations:
city: Seriate
country: Italy
facility: Ospedale Bolognini
state: Bergamo
city: Casarano
country: Italy
facility: P.O. F. Ferrari
state: Lecce
city: Pieve di Coriano
country: Italy
facility: A.O. Destra Secchia
state: Mantova
city: Castellammare
country: Italy
facility: Ospedale San Leonardo
state: Napoli
city: Borgomanero
country: Italy
facility: Ospedale SS. Trinità
state: Novara
city: Pescia
country: Italy
facility: Ospedale SS. Cosma e Damiano
state: Pistoia
city: Moncalieri
country: Italy
facility: Ospedale Santa Croce
state: Torino
city: Gallarate
country: Italy
facility: Ospedale S.Antonio Abate
state: Varese
city: Mestre
country: Italy
facility: Ospedale Dell'Angelo
state: Venezia
city: Ancona
country: Italy
facility: A.O.U. Ospedali Riuniti di Ancona
city: Biella
country: Italy
facility: Ospedale Degli Infermi
city: Catania
country: Italy
facility: A.O.U. Policlinico-Vittorio Emanuele
city: Empoli
country: Italy
facility: Ospedale S. Giuseppe
city: Isernia
country: Italy
facility: Osp. Civile F. Veneziale
city: Lecce
country: Italy
facility: P.O. Vito Fazzi
city: Napoli
country: Italy
facility: A.O.R.N. dei Colli - PO "V. Monaldi"
city: Pordenone
country: Italy
facility: A.O. Santa Maria Degli Angeli
city: Potenza
country: Italy
facility: A.O. San Carlo
city: Rimini
country: Italy
facility: Ospedale Degli Infermi
city: Venezia
country: Italy
facility: Ospedale SS. Giovanni e Paolo
Study officials:
affiliation: A.O.U. Ospedali Riuniti, Ancona
name: Alessandro Capucci
role: PRINCIPAL_INVESTIGATOR
affiliation: A.O.U. Policlinico-Vittorio Emanuele, Catania
name: Valeria Calvi
role: PRINCIPAL_INVESTIGATOR
affiliation: A.O. Santa Maria degli Angeli, Pordenone
name: Marco Brieda
role: PRINCIPAL_INVESTIGATOR
affiliation: P.O. Vito Fazzi, Lecce
name: Ennio Pisanò
role: PRINCIPAL_INVESTIGATOR
affiliation: Ospedale Bolognini, Seriate
name: Vittorio Giudici
role: PRINCIPAL_INVESTIGATOR
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citation: Calvi V, Pisano EC, Brieda M, Melissano D, Castaldi B, Guastaferro C, Nigro G, Madalosso M, Orsida D, Rovai N, Gargaro A, Capucci A. Atrioventricular Interval Extension Is Highly Efficient in Preventing Unnecessary Right Ventricular Pacing in Sinus Node Disease: A Randomized Cross-Over Study Versus Dual- to Atrial Single-Chamber Mode Switch. JACC Clin Electrophysiol. 2017 May;3(5):482-490. doi: 10.1016/j.jacep.2016.11.011. Epub 2017 Feb 1.