Prevention of Inappropriate Therapies and MACCE. Single-chamber ICD Clinical Trial
— PREVENT-DXOfficial 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
| NCT number | NCT04344704 |
| Other study ID # | DX01 |
| Secondary ID | |
| Status | Recruiting |
| Phase | |
| First received | |
| Last updated | |
| Start date | November 2, 2018 |
| Est. completion date | March 2023 |
Prevention of inappropriate therapies and serious adverse cardiac and cerebrovascular events with a single chamber implantable defibrillator with DX floating dipole atrial detection
| Status | Recruiting |
| Enrollment | 462 |
| Est. completion date | March 2023 |
| Est. primary completion date | September 2022 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - 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 Exclusion Criteria: - 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. - 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. |
| Country | Name | City | State |
|---|---|---|---|
| Spain | Complejo Hospitalario Universitario A Coruña | A Coruña | |
| Spain | Hospital Universitario Germans Trias i Pujol | Badalona | Barcelona |
| Spain | Hospital Universitario de Donostia | Donostia | Guipúzcoa |
| Spain | Hospital Universitario de Araba | Gasteiz / Vitoria | Alava |
| Spain | Hospital Universitario Josep Trueta | Girona | |
| Spain | Hospital Universitario de Bellvitge | L'Hospitalet De Llobregat | Barcelona |
| Spain | Hospital San Pedro | Logroño | |
| Spain | Hospital Universitario La Paz | Madrid | |
| Spain | Hospital Universitario Puerta de Hierro | Majadahonda | Madrid |
| Spain | Hospital Universitario Virgen de la Victoria | Málaga | |
| Spain | Complejo Hospitalario Universitario de Canarias | Santa Cruz De Tenerife | Tenerife |
| Spain | Hospital Universitario Clínico de Santiago | Santiago De Compostela | A Coruña |
| Spain | Hospital Universitario de Tarragona Joan XXIII | Tarragona | |
| Spain | Hospital Universitario y Politécnico La Fe | Valencia | |
| Spain | Hospital Clínico y Universitario de Valladolid | Valladolid | |
| Spain | Hospital Álvaro Cunqueiro | Vigo | Pontevedra |
| Lead Sponsor | Collaborator |
|---|---|
| Trialance SCCL |
Spain,
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):197 — View Citation
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-Defibrillat — View Citation
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 defibrilla — View Citation
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 R — View Citation
Defaye P, Boveda S, Klug D, Beganton F, Piot O, Narayanan K, Périer 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 preven — View Citation
Friedman PA, Bradley D, Koestler C, Slusser J, Hodge D, Bailey K, Kusumoto F, Munger TM, Militanu A, Glikson M. A prospective randomized trial of single- or dual-chamber implantable cardioverter-defibrillators to minimize inappropriate shock risk in prima — View Citation
Guédon-Moreau L, Kouakam C, Klug D, Marquié C, Brigadeau F, Boulé S, Blangy H, Lacroix D, Clémenty J, Sadoul N, Kacet S. Decreased delivery of inappropriate shocks achieved by remote monitoring of ICD: a substudy of the ECOST trial. J Cardiovasc Electroph — View Citation
Healey JS, Connolly SJ, Gold MR, Israel CW, Van Gelder IC, Capucci A, Lau CP, Fain E, Yang S, Bailleul C, Morillo CA, Carlson M, Themeles E, Kaufman ES, Hohnloser SH; ASSERT Investigators. Subclinical atrial fibrillation and the risk of stroke. N Engl J M — View Citation
Kloppe A, Proclemer A, Arenal A, Lunati M, Martìnez Ferrer JB, Hersi A, Gulaj M, Wijffels MC, Santi E, Manotta L, Mangoni L, Gasparini M. Efficacy of long detection interval implantable cardioverter-defibrillator settings in secondary prevention populatio — View Citation
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 — View Citation
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 — View Citation
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 Electrophys — View Citation
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. d — View Citation
Miller DJ, Khan MA, Schultz LR, Simpson JR, Katramados AM, Russman AN, Mitsias PD. Outpatient cardiac telemetry detects a high rate of atrial fibrillation in cryptogenic stroke. J Neurol Sci. 2013 Jan 15;324(1-2):57-61. doi: 10.1016/j.jns.2012.10.001. Epu — View Citation
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 mort — View Citation
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 — View Citation
Schwab JO, Bonnemeier H, Kleemann T, Brachmann J, Fischer S, Birkenhauer F, Eberhardt F. Reduction of inappropriate ICD therapies in patients with primary prevention of sudden cardiac death: DECREASE study. Clin Res Cardiol. 2015 Dec;104(12):1021-32. doi: — View Citation
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 — View Citation
Sticherling C, Zabel M, Spencker S, Meyerfeldt U, Eckardt L, Behrens S, Niehaus M; ADRIA Investigators. Comparison of a novel, single-lead atrial sensing system with a dual-chamber implantable cardioverter-defibrillator system in patients without antibrad — View Citation
Tayal AH, Tian M, Kelly KM, Jones SC, Wright DG, Singh D, Jarouse J, Brillman J, Murali S, Gupta R. Atrial fibrillation detected by mobile cardiac outpatient telemetry in cryptogenic TIA or stroke. Neurology. 2008 Nov 18;71(21):1696-701. doi: 10.1212/01.w — View Citation
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.2 — View Citation
Vanhees L, Kornaat M, Defoor J, Aufdemkampe G, Schepers D, Stevens A, Van Exel H, Van Den Beld J, Heidbüchel H, Fagard R. Effect of exercise training in patients with an implantable cardioverter defibrillator. Eur Heart J. 2004 Jul;25(13):1120-6. — View Citation
Wilkoff BL, Fauchier L, Stiles MK, Morillo CA, Al-Khatib SM, Almendral J, Aguinaga L, Berger RD, Cuesta A, Daubert JP, Dubner S, Ellenbogen KA, Estes NA 3rd, Fenelon G, Garcia FC, Gasparini M, Haines DE, Healey JS, Hurtwitz JL, Keegan R, Kolb C, Kuck KH, — View Citation
Worden NE, Alqasrawi M, Krothapalli SM, Mazur A. "Two for the Price of One": A Single-Lead Implantable Cardioverter-Defibrillator System with a Floating Atrial Dipole. J Atr Fibrillation. 2016 Apr 30;8(6):1396. doi: 10.4022/jafib.1396. eCollection 2016 Ap — View Citation
Ziegler PD, Rogers JD, Ferreira SW, Nichols AJ, Richards M, Koehler JL, Sarkar S. Long-term detection of atrial fibrillation with insertable cardiac monitors in a real-world cryptogenic stroke population. Int J Cardiol. 2017 Oct 1;244:175-179. doi: 10.101 — View Citation
* Note: There are 25 references in all — Click here to view all references
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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. | 24 months | |
| Secondary | Inappropriate therapies distribution | According to the type of indication for an ICD in primary and secondary prevention | 24 months | |
| Secondary | Programming adjustment justification | Adjustments suggested by the European Heart Rhythm Association | 24 months | |
| Secondary | Distribution of inappropriate therapies by chosen schedule | 24 months | ||
| Secondary | Proportion of appropriate and inappropriate diagnoses | By diagnosis group | 24 months | |
| Secondary | Differences in events according to Onset & Stability method versus Morphmatch method | Events in single chamber programming without floating dipole | 24 months | |
| Secondary | Appropriate therapies by group and by indication | Portion of appropriate therapies | 24 months | |
| Secondary | Triggers of Inappropriate therapies | 24 months | ||
| Secondary | Patients presenting atrial fibrillation before inclusion | percentage | 24 months | |
| Secondary | Patients with no prior history of atrial fibrillation (AF) who have AF during study follow-up | Percentage | 24 months | |
| Secondary | General atrial load in patients with and without previous manifestation of atrial fibrillation | 24 months | ||
| Secondary | 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 | 24 months | |
| Secondary | Cerebrovascular events presenting previous episodes of atrial fibrillation | Rate | 24 months |