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Sick Sinus SyndromeVIPERSNCT01528657

Ventricular Pace Suppression Versus Intrinsic Rhythm Support Study

A study testing Ventricular Pace Suppression (Vps) and Intrinsic rhythm support (IRSplus) in people with Sick Sinus Syndrome, run by Biotronik SE & Co. KG at 20 sites in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Sick Sinus Syndrome
What is being tested?
Ventricular Pace Suppression (Vps) and Intrinsic rhythm support (IRSplus)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
230 participants
Where
20 sitesItaly
Study dates
Dec 2011to Aug 2015
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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;

Who cannot join

  • 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;
Show all 13Show fewer
  • 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;

Trial locations and contacts

20 sites in 1 country.

20 sites in 1 country

Italy20 sites

  • A.O.U. Ospedali Riuniti di Ancona

    Ancona

  • Ospedale Degli Infermi

    Biella

  • Ospedale SS. Trinità

    Borgomanero, Novara

  • P.O. F. Ferrari

    Casarano, Lecce

  • Ospedale San Leonardo

    Castellammare di Stabia, Napoli

  • A.O.U. Policlinico-Vittorio Emanuele

    Catania

  • Ospedale S. Giuseppe

    Empoli

  • Ospedale S.Antonio Abate

    Gallarate, Varese

  • Osp. Civile F. Veneziale

    Isernia

  • P.O. Vito Fazzi

    Lecce

  • Ospedale Dell'Angelo

    Mestre, Venezia

  • Ospedale Santa Croce

    Moncalieri, Torino

  • A.O.R.N. dei Colli - PO "V. Monaldi"

    Naples

  • Ospedale SS. Cosma e Damiano

    Pescia, Pistoia

  • A.O. Destra Secchia

    Pieve di Coriano, Mantova

  • A.O. Santa Maria Degli Angeli

    Pordenone

  • A.O. San Carlo

    Potenza

  • Ospedale Degli Infermi

    Rimini

  • Ospedale Bolognini

    Seriate, Bergamo

  • Ospedale SS. Giovanni e Paolo

    Venezia

Other trials in Italy

About this study

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.

Being tested
Ventricular Pace Suppression (Vps), Intrinsic rhythm support (IRSplus)
Keywords
Sick Sinus Syndrome, Ventricular pacing, Minimal ventricular pacing, Ventricular pacing suppression, Intrinsic rhythm support, Long term AV
Medical subject headings
Sick Sinus Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Ventricular Pace Suppression (Vps)Other

    Unnecessary ventricular pacing is avoided by promoting intrinsic conduction. In case of intrinsic conduction, the device switches from a DDD mode to an ADI mode.

  • Intrinsic rhythm support (IRSplus)Other

    All parameters of the AV hysteresis functions are set in a way to maintain spontaneous AV conduction of the patient's heart as long as possible.

Study groups in NCT01528657
Study groupRoleWhat they receive
Ventricular Pace Suppression (VpS)ExperimentalThe function Ventricular Pace Suppression (VpS) is activated
Receives: Other: Ventricular Pace Suppression (Vps)
Intrinsic Rhythm Support (IRSplus)ExperimentalThe function Intrinsic Rhythm Support (IRSplus) is activated
Receives: Other: Intrinsic rhythm support (IRSplus)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Ventricular pacing percentage

    Measured: 6 months

Secondary outcomes (3)

  1. Long-term atrio-ventricular conduction delay

    Measured: 6 Months

  2. Occurrence of atrial tachycardia or atrial fibrillation events

    Measured: 6 Months

  3. Burden of atrial fibrillation

    Measured: 6 Months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Feb 2012 (estimated)
  2. Study startDec 2011
  3. Primary completionAug 2015
  4. Study completionAug 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
230 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01528657
Sponsor's protocol ID
BA098
Acronym
VIPERS
Status last verified
Oct 2015
First submitted
6 Feb 2012
Last updated
22 Oct 2015
Results posted
No
Data monitoring committee
No

Publications

  • Vassallo JA, Cassidy DM, Miller JM, Buxton AE, Marchlinski FE, Josephson ME. Left ventricular endocardial activation during right ventricular pacing: effect of underlying heart disease. J Am Coll Cardiol. 1986 Jun;7(6):1228-33. doi: 10.1016/s0735-1097(86)80140-1.

    PubMed 3711479

  • Prinzen FW, Peschar M. Relation between the pacing induced sequence of activation and left ventricular pump function in animals. Pacing Clin Electrophysiol. 2002 Apr;25(4 Pt 1):484-98. doi: 10.1046/j.1460-9592.2002.00484.x.

    PubMed 11991375

  • Prinzen FW, Augustijn CH, Arts T, Allessie MA, Reneman RS. Redistribution of myocardial fiber strain and blood flow by asynchronous activation. Am J Physiol. 1990 Aug;259(2 Pt 2):H300-8. doi: 10.1152/ajpheart.1990.259.2.H300.

    PubMed 2386214

  • Thambo JB, Bordachar P, Garrigue S, Lafitte S, Sanders P, Reuter S, Girardot R, Crepin D, Reant P, Roudaut R, Jais P, Haissaguerre M, Clementy J, Jimenez M. Detrimental ventricular remodeling in patients with congenital complete heart block and chronic right ventricular apical pacing. Circulation. 2004 Dec 21;110(25):3766-72. doi: 10.1161/01.CIR.0000150336.86033.8D. Epub 2004 Dec 6.

    PubMed 15583083

  • Kanzaki H, Bazaz R, Schwartzman D, Dohi K, Sade LE, Gorcsan J 3rd. A mechanism for immediate reduction in mitral regurgitation after cardiac resynchronization therapy: insights from mechanical activation strain mapping. J Am Coll Cardiol. 2004 Oct 19;44(8):1619-25. doi: 10.1016/j.jacc.2004.07.036.

    PubMed 15489094

  • Maurer G, Torres MA, Corday E, Haendchen RV, Meerbaum S. Two-dimensional echocardiographic contrast assessment of pacing-induced mitral regurgitation: relation to altered regional left ventricular function. J Am Coll Cardiol. 1984 Apr;3(4):986-91. doi: 10.1016/s0735-1097(84)80357-5.

    PubMed 6707363

  • Vanderheyden M, Goethals M, Anguera I, Nellens P, Andries E, Brugada J, Brugada P. Hemodynamic deterioration following radiofrequency ablation of the atrioventricular conduction system. Pacing Clin Electrophysiol. 1997 Oct;20(10 Pt 1):2422-8. doi: 10.1111/j.1540-8159.1997.tb06081.x.

    PubMed 9358483

  • Nielsen JC, Kristensen L, Andersen HR, Mortensen PT, Pedersen OL, Pedersen AK. A randomized comparison of atrial and dual-chamber pacing in 177 consecutive patients with sick sinus syndrome: echocardiographic and clinical outcome. J Am Coll Cardiol. 2003 Aug 20;42(4):614-23. doi: 10.1016/s0735-1097(03)00757-5.

    PubMed 12932590

  • Nielsen JC, Andersen HR, Thomsen PE, Thuesen L, Mortensen PT, Vesterlund T, Pedersen AK. Heart failure and echocardiographic changes during long-term follow-up of patients with sick sinus syndrome randomized to single-chamber atrial or ventricular pacing. Circulation. 1998 Mar 17;97(10):987-95. doi: 10.1161/01.cir.97.10.987.

    PubMed 9529267

  • Nahlawi M, Waligora M, Spies SM, Bonow RO, Kadish AH, Goldberger JJ. Left ventricular function during and after right ventricular pacing. J Am Coll Cardiol. 2004 Nov 2;44(9):1883-8. doi: 10.1016/j.jacc.2004.06.074.

    PubMed 15519023

  • Sweeney MO, Hellkamp AS, Ellenbogen KA, Greenspon AJ, Freedman RA, Lee KL, Lamas GA; MOde Selection Trial Investigators. Adverse effect of ventricular pacing on heart failure and atrial fibrillation among patients with normal baseline QRS duration in a clinical trial of pacemaker therapy for sinus node dysfunction. Circulation. 2003 Jun 17;107(23):2932-7. doi: 10.1161/01.CIR.0000072769.17295.B1. Epub 2003 Jun 2.

    PubMed 12782566

  • 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.

    PubMed 29759604

Questions about this trial

What is this clinical trial studying?

A study testing Ventricular Pace Suppression (Vps) and Intrinsic rhythm support (IRSplus) in people with Sick Sinus Syndrome, run by Biotronik SE & Co. KG at 20 sites in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 20 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Ventricular pacing percentage (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01528657, which also lists 12 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2015.

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