Assessment of Arrhythmic BuRdEn With Post-ProCedural COntinuous ElectRocarDiographic Monitoring in Patients Undergoing Transcatheter Aortic Valve Implantation: The RECORD Study

TAVI Clinical Trial

Official title:

Assessment of Arrhythmic BuRdEn With Post-ProCedural COntinuous ElectRocarDiographic Monitoring in Patients Undergoing Transcatheter Aortic Valve Implantation: The RECORD Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04298593
• Other study ID #: RECORD
• Status: Active, not recruiting
• Phase: N/A
• Start date: June 28, 2019
• Est. completion date: December 2025

Study information

• Verified date: December 2023
• Source: Institut universitaire de cardiologie et de pneumologie de Québec, University Laval
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

TAVI recipients exhibit a high burden of arrhythmic events early after the procedure. ECG continuous monitoring could be useful to diagnose and facilitate early implementation of specific therapeutic measures in these patients.

Description:

Prospective registry including patients accepted by the heart team for a TAVI procedure. Patients will undergo a prolonged continuous ECG monitoring using the CardioSTAT® device after hospital discharge. Following the TAVI procedure, continuous ECG monitoring will start just before hospital discharge and prolonged up to 4 weeks. There won't be any restriction regarding the type of valve and approach used for the TAVI procedure. All type of arrhythmic events will be recorded, as well as the specific therapeutic measures implemented upon the diagnosis of the arrhythmic event. Analyses of the CardioSTAT will be done at 2 and 4 weeks following hospital discharge. Clinical follow-up will be performed at 14 days (analysis of CardioSTAT® record), 28 days (analysis of CardioSTAT record), 1 year post-TAVI and yearly thereafter up to 5-year follow-up.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 200
• Est. completion date: December 2025
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients with severe aortic stenosis undergoing TAVI with either balloon or self-expandable valves.

Exclusion Criteria:

• Failure to provide informed consent.
• Prior or post-procedural pacemaker
• In-hospital death
• Logistic reasons precluding ECG monitoring within the 4 weeks after the procedure
• Participation in another continuous ECG monitoring post-TAVI trial

Related Conditions & MeSH terms

• ECG Monitoring
• TAVI

Intervention

Device:
• Cardiostat
This is a prospective observational study including patients accepted by the heart team for a TAVI procedure. There will be no restriction regarding the type of valve and approach used for the TAVI procedure. Following the TAVI procedure, the patients will be under telemetry until hospital discharge and, at hospital discharge, they will be monitorized up to 4 more weeks using the CardioSTAT® device.

Locations

Country	Name	City	State
Canada	IUCPQ	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Institut universitaire de cardiologie et de pneumologie de Québec, University Laval

Country where clinical trial is conducted

Canada, 

References & Publications (9)

Auffret V, Puri R, Urena M, Chamandi C, Rodriguez-Gabella T, Philippon F, Rodes-Cabau J. Conduction Disturbances After Transcatheter Aortic Valve Replacement: Current Status and Future Perspectives. Circulation. 2017 Sep 12;136(11):1049-1069. doi: 10.1161/CIRCULATIONAHA.117.028352. — View Citation

Baumgartner H, Falk V, Bax JJ, De Bonis M, Hamm C, Holm PJ, Iung B, Lancellotti P, Lansac E, Munoz DR, Rosenhek R, Sjogren J, Mas PT, Vahanian A, Walther T, Wendler O, Windecker S, Zamorano JL. 2017 ESC/EACTS Guidelines for the Management of Valvular Heart Disease. Rev Esp Cardiol (Engl Ed). 2018 Feb;71(2):110. doi: 10.1016/j.rec.2017.12.013. No abstract available. English, Spanish. — View Citation

MacMillan RM, Demorizi NM, Gessman LJ, Maranhao V. Correlates of prolonged HV conduction in aortic stenosis. Am Heart J. 1985 Jul;110(1 Pt 1):56-60. doi: 10.1016/0002-8703(85)90514-9. — View Citation

Mautner RK, Phillips JH. Atrioventricular and intraventricular conduction disturbances in aortic valvular disease. South Med J. 1980 May;73(5):572-8, 581. doi: 10.1097/00007611-198005000-00008. — View Citation

Moreno R, Dobarro D, Lopez de Sa E, Prieto M, Morales C, Calvo Orbe L, Moreno-Gomez I, Filgueiras D, Sanchez-Recalde A, Galeote G, Jimenez-Valero S, Lopez-Sendon JL. Cause of complete atrioventricular block after percutaneous aortic valve implantation: insights from a necropsy study. Circulation. 2009 Aug 4;120(5):e29-30. doi: 10.1161/CIRCULATIONAHA.109.849281. No abstract available. — View Citation

Rodes-Cabau J, Urena M, Nombela-Franco L, Amat-Santos I, Kleiman N, Munoz-Garcia A, Atienza F, Serra V, Deyell MW, Veiga-Fernandez G, Masson JB, Canadas-Godoy V, Himbert D, Castrodeza J, Elizaga J, Francisco Pascual J, Webb JG, de la Torre JM, Asmarats L, Pelletier-Beaumont E, Philippon F. Arrhythmic Burden as Determined by Ambulatory Continuous Cardiac Monitoring in Patients With New-Onset Persistent Left Bundle Branch Block Following Transcatheter Aortic Valve Replacement: The MARE Study. JACC Cardiovasc Interv. 2018 Aug 13;11(15):1495-1505. doi: 10.1016/j.jcin.2018.04.016. Epub 2018 Jul 18. — View Citation

Siontis GCM, Praz F, Lanz J, Vollenbroich R, Roten L, Stortecky S, Raber L, Windecker S, Pilgrim T. New-onset arrhythmias following transcatheter aortic valve implantation: a systematic review and meta-analysis. Heart. 2018 Jul;104(14):1208-1215. doi: 10.1136/heartjnl-2017-312310. Epub 2017 Dec 23. — View Citation

Urena M, Rodes-Cabau J. Conduction Abnormalities: The True Achilles' Heel of Transcatheter Aortic Valve Replacement? JACC Cardiovasc Interv. 2016 Nov 14;9(21):2217-2219. doi: 10.1016/j.jcin.2016.09.040. No abstract available. — View Citation

Widgren V, Dencker M, Juhlin T, Platonov P, Willenheimer R. Aortic stenosis and mitral regurgitation as predictors of atrial fibrillation during 11 years of follow-up. BMC Cardiovasc Disord. 2012 Oct 18;12:92. doi: 10.1186/1471-2261-12-92. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of arrhythmic events	Incidence of arrhythmic events after discharge in TAVI recipients.	within the first weeks after the procedure, an average of 4 weeks
Primary	Type of arrhythmic events	Type of arrhythmic events after discharge in TAVI recipients.	within the first weeks after the procedure, an average of 4 weeks
Primary	Incidence of arrhythmic events and treatment modification	Incidence of arrhythmic events leading to a specific change in treatment.	within the first weeks after the procedure, an average of 4 weeks
Primary	Type of arrhythmic events and treatment modification	Type of arrhythmic events leading to a specific change in treatment.	within the first weeks after the procedure, an average of 4 weeks
Secondary	Number of participants with pacemaker	Incidence of permanent pacemaker implantation after the procedure.	Through study completion, an average of 5 years
Secondary	Number of participants with treatment modification	Number of participants who required change in their medication (anticoagulation, antiarrhythmic) after the procedure.	Through study completion, an average of 5 years