Prevention of Inappropriate Therapies and MACCE. Single-chamber ICDPREVENT-DXNCT04344704

Prevention of Inappropriate Therapies and MACCE With a Single Chamber ICD With DX Floating Dipole Atrial Detection

An observational study of Prevention of Inappropriate Therapies and MACCE. Single-chamber ICD, run by Trialance SCCL at 16 sites in Spain.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

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Trial summary

Prevention of inappropriate therapies and serious adverse cardiac and cerebrovascular events with a single chamber implantable defibrillator with DX floating dipole atrial detection Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Prevention of Inappropriate Therapies and MACCE. Single-chamber ICD
What is being tested?: Single chamber DAI device with floating atrial dipole
How many people: 462 participants
Where: 16 sitesSpain
Study dates: 2 Nov 2018to Mar 2023
How long will I take part?: 24 Months
Phase: Observational
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

Study population: Population with an accepted indication for an implantable automatic defibrillator

Who may be able to join

Patients with an indication of a single chamber ICD due to high risk of sudden death.
Patients with and without a prior history of AF.
Patients with indication for primary and secondary prevention.
Device optimized for the discrimination of supraventricular events.
DX device implant with single floating cable.
Activation of "Home Monitoring" function.
Over 18 years.
Signature of informed consent

Who cannot join

Indication for permanent atrial pacing according to current pacing guidelines.
Congestive heart failure grade IV.
Candidates for Cardiac Resynchronization Therapy.
Patients with a previous device.
Permanent Atrial Fibrillation.
Life expectancy less than 12 months.

Show all 11Show fewer

Pregnant or lactating women.
Patients who are unable to understand the nature of the study.
Subjects with irreversible brain damage caused by pre-existing brain disease.
Heart transplant 6 months prior to recruitment or expected in the next 3 months.
Cardiac surgery 3 months prior to recruitment or planned for the next 3 months.

Trial locations and contacts

16 sites in 1 country.

Xavier Molina Figueras, PharmD, PhD contact

+34 689900009

xmolina@trialance.com

Marta Barbacid Hernández, PharmD, MSc contact

+34 630767668

mbarbacid@trialance.com

City, postcode or hospital

Sites recruiting now only

16 sites in 1 country

Spain16 sites, 13 recruiting

Complejo Hospitalario Universitario A Coruña
A Coruña, 15006
Xavier Molina Figueras, PharmD, PhD, +34 689900009, xmolina@trialance.com
Alicia Moreno Bisbal, MathD, MSc, +34 620 88 20 55, alicia.moreno@biotronik.com
Recruiting
Hospital Universitario Germans Trias i Pujol
Badalona, Barcelona, 08916
Xavier Molina Figueras, PharmD, PhD, +34 689900009, xmolina@trialance.com
Alicia Moreno Bisbal, MathD, MSc, +34 620 88 20 55, alicia.moreno@biotronik.com
Recruiting
Hospital Universitario de Donostia
Donostia / San Sebastian, Guipúzcoa, 20014
Xavier Molina Figueras, PharmD, PhD, +34 689900009, xmolina@trialance.com
Alicia Moreno Bisbal, MathD, MSc, +34 620 88 20 55, alicia.moreno@biotronik.com
Recruiting
Hospital Universitario Josep Trueta
Girona, 17007
Xavier Molina Figueras, PharmD, PhD, +34 689900009, xmolina@trialance.com
Alicia Moreno Bisbal, MathD, MSc, +34 620 88 20 55, alicia.moreno@biotronik.com
Recruiting
Hospital Universitario de Bellvitge
L'Hospitalet de Llobregat, Barcelona, 08907
Xavier Molina Figueras, PharmD, PhD, +34 689900009, xmolina@trialance.com
Alicia Moreno Bisbal, MathD, MSc, +34 620 88 20 55, alicia.moreno@biotronik.com
Recruiting
Hospital San Pedro
Logroño, 26006
Xavier Molina Figueras, PharmD, PhD, +34 689900009, xmolina@trialance.com
Alicia Moreno Bisbal, MathD, MSc, +34 620 88 20 55, alicia.moreno@biotronik.com
Recruiting
Hospital Universitario La Paz
Madrid, 28046
Xavier Molina Figueras, PharmD, PhD, +34 689900009, xmolina@trialance.com
Alicia Moreno bisbal, MathD, MSc, +34 620 88 20 55, alicia.moreno@biotronik.com
Recruiting
Hospital Universitario Puerta de Hierro
Majadahonda, Madrid, 28222
Xavier Molina Figueras, PharmD, PhD, +34 689900009, xmolina@trialance.com
Alicia Moreno Bisbal, MathD, MSc, +34 620 88 20 55, alicia.moreno@biotronik.com
Recruiting
Hospital Universitario Virgen de la Victoria
Málaga, 29010
Active, not recruiting
Complejo Hospitalario Universitario de Canarias
Santa Cruz de Tenerife, Tenerife, 38320
Active, not recruiting
Hospital Universitario Clínico de Santiago
Santiago de Compostela, A Coruña, 15706
Active, not recruiting
Hospital Universitario de Tarragona Joan XXIII
Tarragona, 43005
Xavier Molina Figueras, PharmD, PhD, +34 689900009, xmolina@trialance.com
Alicia Moreno bisbal, MathD, MSc, +34 620 88 20 55, alicia.moreno@biotronik.com
Recruiting
Hospital Universitario y Politécnico La Fe
Valencia, 46026
Xavier Molina Figueras, PharmD, PhD, +34 689900009, xmolina@trialance.com
Alicia Moreno Bisbal, MathD, MSc, +34 620 88 20 55, alicia.moreno@biotronik.com
Recruiting
Hospital Clínico y Universitario de Valladolid
Valladolid, 47003
Xavier Molina Figueras, PharmDF, PhD, +34 689900009, xmolina@trialance.com
Alicia Moreno Bisbal, MathD, MSc, +34 620 88 20 55, alicia.moreno@biotronik.com
Recruiting
Hospital Álvaro Cunqueiro
Vigo, Pontevedra, 36213
Xavier Molina Figueras, PharmD, PhD, +34 689900009, xmolina@trialance.com
Alicia Moreno Bisbal, MathD, MSc, +34 620 88 20 55, alicia.moreno@biotronik.com
Recruiting
Hospital Universitario de Araba
Vitoria-Gasteiz, Alava, 01009
Xavier Molina Figueras, PharmD, PhD, +34 689900009, xmolina@trialance.com
Alicia Moreno bisbal, MathD, MSc, +34 620 88 20 55, alicia.moreno@biotronik.com
Recruiting

Other trials in Spain

About this study

Official title: Prevention of Inappropriate Therapies and Serious Adverse Cardiac and Cerebrovascular Events With a Single Chamber Implantable Cardioverter Defibrillator (ICD) With DX Floating Dipole Detection. PREVENT DX

Prevention of inappropriate therapies and serious adverse cardiac and cerebrovascular events with a single chamber implantable defibrillator with DX floating dipole atrial detection

Read the detailed description

Prospective, randomized, open-label, multicenter, international study in a population with an accepted indication for an implantable automatic defibrillator.

The main objective is to know the different values of the rates of inappropriate therapies, of serious cardiac and cerebrovascular adverse events, and of the appropriate detections in single-chamber ICD devices, with optimized programming according to the patient's arrhythmic history, using the three discrimination methods. arrhythmias: Smart, Onset and Stability, and Morphmatch.

The device under investigation is a single chamber with a floating atrial dipole for the detection of atrial signals.

Patients who are included in the study will present an indication for an automatic cardioverter-defibrillator device according to clinical practice guidelines for an ICD and who also do not have an indication for permanent stimulation in the right atrium. For this reason, the indication of patients will be those that require an ICD without the implantation of an electrode in the atrium, that is, single-chamber ICDs or DX ICDs since both, from the therapeutic point of view, are equivalent.

The centers will follow standard clinical practice to diagnose patients

Conditions: Prevention of Inappropriate Therapies and MACCE. Single-chamber ICD
Being tested: Single chamber DAI device with floating atrial dipole

What participants receive

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

Single chamber DAI device with floating atrial dipoleOther
DAI for the detection of atrial signals with optimized programming, using Smart, Onset \& Stability, and Morphmatch methods

Study groups in NCT04344704
Study group	Role	What they receive
DX devices with SMART headset detection enabled		The SMART detection algorithm is designed to, with the aid of atrial rhythm assessment, discriminate between ventricular tachycardias and a variety of supraventricular tachyarrhythmias for which device intervention is not required or desired Receives: Other: Single chamber DAI device with floating atrial dipole
DX device programmed in single chamber mode		with the activation of one of the available discrimination criteria: * Onset: distinguishes slow onset or onset tachycardias from sudden onset * Stability: distinguishes between irregularly transmitted supraventricular tachycardias and ventricular tachycardias requiring therapy by continuous interval monitoring. * Morphmatch: helps to distinguish between supra and ventricular signals through analysis of episode QRS width Receives: Other: Single chamber DAI device with floating atrial dipole

What is being measured

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

The combined rate of inappropriate therapies and serious adverse cardiac and cerebrovascular events (MACCE) single-chamber devices with floating atrial dipole with the Smart function activated
determine the combined rate is not less than in single-chamber devices without atrial detection using any of the supraventricular arrhythmia discrimination modalities: Onset and Stability, and Morphmatch.
Measured: 24 months

Secondary outcomes (12)

Inappropriate therapies distribution
According to the type of indication for an ICD in primary and secondary prevention
Measured: 24 months
Programming adjustment justification
Adjustments suggested by the European Heart Rhythm Association
Measured: 24 months
Distribution of inappropriate therapies by chosen schedule
Measured: 24 months
Proportion of appropriate and inappropriate diagnoses
By diagnosis group
Measured: 24 months
Differences in events according to Onset & Stability method versus Morphmatch method
Events in single chamber programming without floating dipole
Measured: 24 months
Appropriate therapies by group and by indication
Portion of appropriate therapies
Measured: 24 months
Triggers of Inappropriate therapies
Measured: 24 months
Patients presenting atrial fibrillation before inclusion
percentage
Measured: 24 months
Patients with no prior history of atrial fibrillation (AF) who have AF during study follow-up
Percentage
Measured: 24 months
General atrial load in patients with and without previous manifestation of atrial fibrillation
Measured: 24 months
Percentage of patients with clinical AF (atrial fibrillation) versus subclinical AF (<6 minutes duration).
Clinical AF meaning > 6 minutes duration and subclinical AF meaning <6 minutes duration
Measured: 24 months
Cerebrovascular events presenting previous episodes of atrial fibrillation
Rate
Measured: 24 months

Timeline

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

2 Nov 2018Mar 2023

First posted14 Apr 2020
Study start2 Nov 2018
Primary completionSep 2022 (estimated)
Study completionMar 2023 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (25)Papers the sponsor has linked to this study.
Other trials for Prevention of Inappropriate Therapies and MACCE. Single-chamber ICDStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

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

Study design

Study type: Observational
Observational model: Other
Time perspective: Prospective
Enrolment: 462 participants (estimated)
Target duration: 24 Months

IDs, dates and publications

ClinicalTrials.gov ID: NCT04344704
Sponsor's protocol ID: DX01
Acronym: PREVENT-DX
Status last verified: Apr 2020
First submitted: 2 Apr 2020
Last updated: 14 Apr 2020
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Publications

Guedon-Moreau L, Kouakam C, Klug D, Marquie C, Brigadeau F, Boule S, Blangy H, Lacroix D, Clementy J, Sadoul N, Kacet S. Decreased delivery of inappropriate shocks achieved by remote monitoring of ICD: a substudy of the ECOST trial. J Cardiovasc Electrophysiol. 2014 Jul;25(7):763-70. doi: 10.1111/jce.12405. Epub 2014 Apr 10.
PubMed 24602062
Kolb C, Sturmer M, Sick P, Reif S, Davy JM, Molon G, Schwab JO, Mantovani G, Dan D, Lennerz C, Borri-Brunetto A, Babuty D. Reduced risk for inappropriate implantable cardioverter-defibrillator shocks with dual-chamber therapy compared with single-chamber therapy: results of the randomized OPTION study. JACC Heart Fail. 2014 Dec;2(6):611-9. doi: 10.1016/j.jchf.2014.05.015. Epub 2014 Oct 1.
PubMed 25282033
Boles U, Gul EE, Fitzgerald L, Sadiq Ali F, Nolan C, Aldworth-Gaumond K, Redfearn DR, Baranchuk A, Glover B, Simpson C, Abdollah H, Michael KA. Standardized programming to reduce the burden of inappropriate therapies in implantable cardioverter defibrillators - Single centre follow up results. Indian Pacing Electrophysiol J. 2018 Mar-Apr;18(2):56-60. doi: 10.1016/j.ipej.2017.10.010. Epub 2017 Oct 27.
PubMed 29111168
van Rees JB, Borleffs CJ, de Bie MK, Stijnen T, van Erven L, Bax JJ, Schalij MJ. Inappropriate implantable cardioverter-defibrillator shocks: incidence, predictors, and impact on mortality. J Am Coll Cardiol. 2011 Feb 1;57(5):556-62. doi: 10.1016/j.jacc.2010.06.059.
PubMed 21272746
Moss AJ, Schuger C, Beck CA, Brown MW, Cannom DS, Daubert JP, Estes NA 3rd, Greenberg H, Hall WJ, Huang DT, Kautzner J, Klein H, McNitt S, Olshansky B, Shoda M, Wilber D, Zareba W; MADIT-RIT Trial Investigators. Reduction in inappropriate therapy and mortality through ICD programming. N Engl J Med. 2012 Dec 13;367(24):2275-83. doi: 10.1056/NEJMoa1211107. Epub 2012 Nov 6.
PubMed 23131066
Kutyifa V, Moss AJ, Schuger C, McNitt S, Polonsky B, Ruwald AH, Ruwald MH, Daubert JP, Zareba W. Reduction in Inappropriate ICD Therapy in MADIT-RIT Patients Without History of Atrial Tachyarrhythmia. J Cardiovasc Electrophysiol. 2015 Aug;26(8):879-884. doi: 10.1111/jce.12692. Epub 2015 Jun 15.
PubMed 25917337
Vanhees L, Kornaat M, Defoor J, Aufdemkampe G, Schepers D, Stevens A, Van Exel H, Van Den Beld J, Heidbuchel H, Fagard R. Effect of exercise training in patients with an implantable cardioverter defibrillator. Eur Heart J. 2004 Jul;25(13):1120-6. doi: 10.1016/j.ehj.2004.04.034.
PubMed 15231370
Sterns LD, Meine M, Kurita T, Meijer A, Auricchio A, Ando K, Leng CT, Okumura K, Sapp JL, Brown ML, Lexcen DR, Gerritse B, Schloss EJ. Extended detection time to reduce shocks is safe in secondary prevention patients: The secondary prevention substudy of PainFree SST. Heart Rhythm. 2016 Jul;13(7):1489-96. doi: 10.1016/j.hrthm.2016.03.022. Epub 2016 Mar 14.
PubMed 26988379
Auricchio A, Hudnall JH, Schloss EJ, Sterns LD, Kurita T, Meijer A, Fagan DH, Rogers T. Inappropriate shocks in single-chamber and subcutaneous implantable cardioverter-defibrillators: a systematic review and meta-analysis. Europace. 2017 Dec 1;19(12):1973-1980. doi: 10.1093/europace/euw415.
PubMed 28340005
Boersma L, Barr C, Knops R, Theuns D, Eckardt L, Neuzil P, Scholten M, Hood M, Kuschyk J, Jones P, Duffy E, Husby M, Stein K, Lambiase PD; EFFORTLESS Investigator Group. Implant and Midterm Outcomes of the Subcutaneous Implantable Cardioverter-Defibrillator Registry: The EFFORTLESS Study. J Am Coll Cardiol. 2017 Aug 15;70(7):830-841. doi: 10.1016/j.jacc.2017.06.040.
PubMed 28797351
Cay S, Canpolat U, Ucar F, Ozeke O, Ozcan F, Topaloglu S, Aras D. Programming implantable cardioverter-defibrillator therapy zones to high ranges to prevent delivery of inappropriate device therapies in patients with primary prevention: results from the RISSY-ICD (Reduction of Inappropriate ShockS bY InCreaseD zones) trial. Am J Cardiol. 2015 May 1;115(9):1235-43. doi: 10.1016/j.amjcard.2015.01.558. Epub 2015 Feb 12.
PubMed 25765588
Defaye P, Boveda S, Klug D, Beganton F, Piot O, Narayanan K, Perier MC, Gras D, Fauchier L, Bordachar P, Algalarrondo V, Babuty D, Deharo JC, Leclercq C, Marijon E, Sadoul N; DAI-PP Investigators. Dual- vs. single-chamber defibrillators for primary prevention of sudden cardiac death: long-term follow-up of the Defibrillateur Automatique Implantable-Prevention Primaire registry. Europace. 2017 Sep 1;19(9):1478-1484. doi: 10.1093/europace/euw230.
PubMed 28340096
Kreuz J, Balta O, Liliegren N, Mellert F, Esmailzadeh B, Nickenig G, Schwab JO. Incidence and characteristics of appropriate and inappropriate therapies in recipients of ICD implanted for primary prevention of sudden cardiac death. Pacing Clin Electrophysiol. 2007 Jan;30 Suppl 1:S125-7. doi: 10.1111/j.1540-8159.2007.00621.x.
PubMed 17302687
Konstantino Y, Haim M, Boxer J, Goldenberg I, Feldman A, Michowitz Y, Glikson M, Suleiman M; Israeli Working Group on Pacing and Electrophysiology. Clinical Outcomes of Single- versus Dual-Chamber Implantable Cardioverter Defibrillators: Lessons from the Israeli ICD Registry. J Cardiovasc Electrophysiol. 2016 Jun;27(6):718-23. doi: 10.1111/jce.12953. Epub 2016 Mar 18.
PubMed 26852908
Oginosawa Y, Kohno R, Honda T, Kikuchi K, Nozoe M, Uchida T, Minamiguchi H, Sonoda K, Ogawa M, Ideguchi T, Kizaki Y, Nakamura T, Oba K, Higa S, Yoshida K, Tsunoda S, Fujino Y, Abe H. Superior Rhythm Discrimination With the SmartShock Technology Algorithm - Results of the Implantable Defibrillator With Enhanced Features and Settings for Reduction of Inaccurate Detection (DEFENSE) Trial. Circ J. 2017 Aug 25;81(9):1272-1277. doi: 10.1253/circj.CJ-16-1330. Epub 2017 Apr 20.
PubMed 28428489

Study at a glance

From the registry record, last updated by the sponsor on 14 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Prevention of Inappropriate Therapies and Serious Adverse Cardiac and Cerebrovascular Events With a Single Chamber Implantable Cardioverter Defibrillator (ICD) With DX Floating Dipole Detection. PREVENT DX
ClinicalTrials.gov ID: NCT04344704
Acronym / sponsor ID: PREVENT-DX / DX01
Conditions: Prevention of Inappropriate Therapies and MACCE. Single-chamber ICD
Study type: Observational
Recruitment status: Unknown status
Enrolment: 462 participants (estimated)
Lead sponsor: Trialance SCCLIndustry (pharma, biotech, devices)
Study start: 2 Nov 2018 (actual)
Primary completion: Sep 2022 (estimated)
Study completion: Mar 2023 (estimated)
First posted: 14 Apr 2020 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Prevention of inappropriate therapies and serious adverse cardiac and cerebrovascular events with a single chamber implantable defibrillator with DX floating dipole atrial detection

Detailed description

Prospective, randomized, open-label, multicenter, international study in a population with an accepted indication for an implantable automatic defibrillator.

The device under investigation is a single chamber with a floating atrial dipole for the detection of atrial signals.

The centers will follow standard clinical practice to diagnose patients

Study design

Observational model: Other
Time perspective: Prospective
Target follow-up: 24 Months
Number of arms: 2

Arm	Type	Receives
DX devices with SMART headset detection enabled	–	Other: Single chamber DAI device with floating atrial dipoleThe SMART detection algorithm is designed to, with the aid of atrial rhythm assessment, discriminate between ventricular tachycardias and a variety of supraventricular tachyarrhythmias for which device intervention is not required or desired
DX device programmed in single chamber mode	–	Other: Single chamber DAI device with floating atrial dipolewith the activation of one of the available discrimination criteria: * Onset: distinguishes slow onset or onset tachycardias from sudden onset * Stability: distinguishes between irregularly transmitted supraventricular tachycardias and ventricular tachycardias requiring therapy by continuous interval monitoring. * Morphmatch: helps to distinguish between supra and ventricular signals through analysis of episode QRS width

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Population with an accepted indication for an implantable automatic defibrillator

Key inclusion criteria (8 listed)

Patients with an indication of a single chamber ICD due to high risk of sudden death.
Patients with and without a prior history of AF.
Patients with indication for primary and secondary prevention.
Device optimized for the discrimination of supraventricular events.
DX device implant with single floating cable.

Key exclusion criteria (11 listed)

Indication for permanent atrial pacing according to current pacing guidelines.
Congestive heart failure grade IV.
Candidates for Cardiac Resynchronization Therapy.
Patients with a previous device.
Permanent Atrial Fibrillation.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Single chamber DAI device with floating atrial dipoleDAI for the detection of atrial signals with optimized programming, using Smart, Onset \& Stability, and Morphmatch methods	Other	DX device programmed in single chamber mode, DX devices with SMART headset detection enabled

Primary outcome

The combined rate of inappropriate therapies and serious adverse cardiac and cerebrovascular events (MACCE) single-chamber devices with floating atrial dipole with the Smart function activated
Time frame: 24 months
determine the combined rate is not less than in single-chamber devices without atrial detection using any of the supraventricular arrhythmia discrimination modalities: Onset and Stability, and Morphmatch.

12 secondary outcomes

Inappropriate therapies distribution
Time frame: 24 months
Programming adjustment justification
Time frame: 24 months
Distribution of inappropriate therapies by chosen schedule
Time frame: 24 months
Proportion of appropriate and inappropriate diagnoses
Time frame: 24 months
Differences in events according to Onset & Stability method versus Morphmatch method
Time frame: 24 months
Appropriate therapies by group and by indication
Time frame: 24 months
Triggers of Inappropriate therapies
Time frame: 24 months
Patients presenting atrial fibrillation before inclusion
Time frame: 24 months
Patients with no prior history of atrial fibrillation (AF) who have AF during study follow-up
Time frame: 24 months
General atrial load in patients with and without previous manifestation of atrial fibrillation
Time frame: 24 months
Percentage of patients with clinical AF (atrial fibrillation) versus subclinical AF (<6 minutes duration).
Time frame: 24 months
Cerebrovascular events presenting previous episodes of atrial fibrillation
Time frame: 24 months

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2020.
Results publication: PubMed 24602062Guedon-Moreau L, Kouakam C, Klug D, Marquie C, Brigadeau F, Boule S, Blangy H, Lacroix D, Clementy J, Sadoul N, Kacet S. Decreased delivery of inappropriate shocks achieved by remote monitoring of ICD: a substudy of the ECOST trial. J Cardiovasc Electrophysiol. 2014 Jul;25(7):763-70. doi: 10.1111/jce.12405. Epub 2014 Apr 10.
Results publication: PubMed 25282033Kolb C, Sturmer M, Sick P, Reif S, Davy JM, Molon G, Schwab JO, Mantovani G, Dan D, Lennerz C, Borri-Brunetto A, Babuty D. Reduced risk for inappropriate implantable cardioverter-defibrillator shocks with dual-chamber therapy compared with single-chamber therapy: results of the randomized OPTION study. JACC Heart Fail. 2014 Dec;2(6):611-9. doi: 10.1016/j.jchf.2014.05.015. Epub 2014 Oct 1.
Results publication: PubMed 29111168Boles U, Gul EE, Fitzgerald L, Sadiq Ali F, Nolan C, Aldworth-Gaumond K, Redfearn DR, Baranchuk A, Glover B, Simpson C, Abdollah H, Michael KA. Standardized programming to reduce the burden of inappropriate therapies in implantable cardioverter defibrillators - Single centre follow up results. Indian Pacing Electrophysiol J. 2018 Mar-Apr;18(2):56-60. doi: 10.1016/j.ipej.2017.10.010. Epub 2017 Oct 27.
Results publication: PubMed 21272746van Rees JB, Borleffs CJ, de Bie MK, Stijnen T, van Erven L, Bax JJ, Schalij MJ. Inappropriate implantable cardioverter-defibrillator shocks: incidence, predictors, and impact on mortality. J Am Coll Cardiol. 2011 Feb 1;57(5):556-62. doi: 10.1016/j.jacc.2010.06.059.
Results publication: PubMed 23131066Moss AJ, Schuger C, Beck CA, Brown MW, Cannom DS, Daubert JP, Estes NA 3rd, Greenberg H, Hall WJ, Huang DT, Kautzner J, Klein H, McNitt S, Olshansky B, Shoda M, Wilber D, Zareba W; MADIT-RIT Trial Investigators. Reduction in inappropriate therapy and mortality through ICD programming. N Engl J Med. 2012 Dec 13;367(24):2275-83. doi: 10.1056/NEJMoa1211107. Epub 2012 Nov 6.
Results publication: PubMed 25917337Kutyifa V, Moss AJ, Schuger C, McNitt S, Polonsky B, Ruwald AH, Ruwald MH, Daubert JP, Zareba W. Reduction in Inappropriate ICD Therapy in MADIT-RIT Patients Without History of Atrial Tachyarrhythmia. J Cardiovasc Electrophysiol. 2015 Aug;26(8):879-884. doi: 10.1111/jce.12692. Epub 2015 Jun 15.
Results publication: PubMed 15231370Vanhees L, Kornaat M, Defoor J, Aufdemkampe G, Schepers D, Stevens A, Van Exel H, Van Den Beld J, Heidbuchel H, Fagard R. Effect of exercise training in patients with an implantable cardioverter defibrillator. Eur Heart J. 2004 Jul;25(13):1120-6. doi: 10.1016/j.ehj.2004.04.034.
Results publication: PubMed 26988379Sterns LD, Meine M, Kurita T, Meijer A, Auricchio A, Ando K, Leng CT, Okumura K, Sapp JL, Brown ML, Lexcen DR, Gerritse B, Schloss EJ. Extended detection time to reduce shocks is safe in secondary prevention patients: The secondary prevention substudy of PainFree SST. Heart Rhythm. 2016 Jul;13(7):1489-96. doi: 10.1016/j.hrthm.2016.03.022. Epub 2016 Mar 14.
Results publication: PubMed 28340005Auricchio A, Hudnall JH, Schloss EJ, Sterns LD, Kurita T, Meijer A, Fagan DH, Rogers T. Inappropriate shocks in single-chamber and subcutaneous implantable cardioverter-defibrillators: a systematic review and meta-analysis. Europace. 2017 Dec 1;19(12):1973-1980. doi: 10.1093/europace/euw415.
Results publication: PubMed 28797351Boersma L, Barr C, Knops R, Theuns D, Eckardt L, Neuzil P, Scholten M, Hood M, Kuschyk J, Jones P, Duffy E, Husby M, Stein K, Lambiase PD; EFFORTLESS Investigator Group. Implant and Midterm Outcomes of the Subcutaneous Implantable Cardioverter-Defibrillator Registry: The EFFORTLESS Study. J Am Coll Cardiol. 2017 Aug 15;70(7):830-841. doi: 10.1016/j.jacc.2017.06.040.
Results publication: PubMed 25765588Cay S, Canpolat U, Ucar F, Ozeke O, Ozcan F, Topaloglu S, Aras D. Programming implantable cardioverter-defibrillator therapy zones to high ranges to prevent delivery of inappropriate device therapies in patients with primary prevention: results from the RISSY-ICD (Reduction of Inappropriate ShockS bY InCreaseD zones) trial. Am J Cardiol. 2015 May 1;115(9):1235-43. doi: 10.1016/j.amjcard.2015.01.558. Epub 2015 Feb 12.
Results publication: PubMed 28340096Defaye P, Boveda S, Klug D, Beganton F, Piot O, Narayanan K, Perier MC, Gras D, Fauchier L, Bordachar P, Algalarrondo V, Babuty D, Deharo JC, Leclercq C, Marijon E, Sadoul N; DAI-PP Investigators. Dual- vs. single-chamber defibrillators for primary prevention of sudden cardiac death: long-term follow-up of the Defibrillateur Automatique Implantable-Prevention Primaire registry. Europace. 2017 Sep 1;19(9):1478-1484. doi: 10.1093/europace/euw230.

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Xavier Molina Figueras, PharmD, PhD contact

+34 689900009

xmolina@trialance.com

Marta Barbacid Hernández, PharmD, MSc contact

+34 630767668

mbarbacid@trialance.com

Ignacio Fernández Lozano, MD principal investigator

Hospital Universitario Puerta de Hierro (HUPH)

16 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Prevention of Inappropriate Therapies and MACCE. Single-chamber ICD, run by Trialance SCCL at 16 sites in Spain.

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 8 inclusion and 11 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: status not confirmed, as of the sponsor's last update on 14 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 16 sites in Spain. 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?

Results are not available in the source record.

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

Contact Xavier Molina Figueras, PharmD, PhD (+34 689900009, xmolina@trialance.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The combined rate of inappropriate therapies and serious adverse cardiac and cerebrovascular events (MACCE) single-chamber devices with floating atrial dipole with the Smart function activated (time frame: 24 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 NCT04344704, which also lists 25 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 14 Apr 2020.