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

NCT04298593 | Active Not Recruiting

• 1 other identifier: RECORD
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

ECG Monitoring; TAVI

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• 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

• 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 Outcomes (2)

• Number of participants with pacemaker

  Through study completion, an average of 5 years

• Number of participants with treatment modification

  Through study completion, an average of 5 years

Study Arms (1)

ECG monitoring

OTHER

All patient will be under telemetry

Device: Cardiostat

Interventions

Cardiostat DEVICE

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.

ECG monitoring

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Institut universitaire de cardiologie et de pneumologie de Québec, University Laval: lead

Study Sites (1)

IUCPQ

Québec, Quebec, G1V 4G5, Canada

Location

Related Publications (9)

• 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.

  PMID: 29425605 BACKGROUND

• 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.

  PMID: 28893961 BACKGROUND

• 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.

  PMID: 27832847 BACKGROUND

• 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.

  PMID: 19652115 BACKGROUND

• 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.

  PMID: 29275399 BACKGROUND

• 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.

  PMID: 30031719 BACKGROUND

• 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.

  PMID: 7375971 BACKGROUND

• 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.

  PMID: 23075140 BACKGROUND

• 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.

  PMID: 4013990 BACKGROUND

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, Principal investigator

Model Details: Prospective registry

Study Record Dates

• First Submitted: January 12, 2020
• First Posted: March 6, 2020
• Study Start: June 28, 2019
• Primary Completion: December 31, 2021
• Study Completion (Estimated): December 1, 2026
• Last Updated: March 27, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)