Aortic StenosisRECORDIINCT07739316
Systematic Ambulatory ECG Monitoring Following TAVI
A study testing Ambulatory ECG monitoring in people with Aortic Stenosis and Conduction Disturbances, run by Institut universitaire de cardiologie et de pneumologie de Québec, University Laval at 1 site in Canada.
Trial summary
This multicenter, prospective, randomized superiority trial will evaluate whether systematic 14-day ambulatory ECG monitoring following hospital discharge after transcatheter aortic valve implantation (TAVI) reduces the risk of sudden death, symptomatic arrhythmic events, or stroke within 1 year compared with standard… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aortic Stenosis, Conduction Disturbances
- What is being tested?
- Ambulatory ECG monitoring
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 754 participants
- Where
- 1 siteCanada
- Study dates
- Aug 2026to Dec 2028
- Phase
- Interventional
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
- Age >18 years
- Successful TAVI procedure.
- Hospitalization discharge ≤72 hrs following the TAVI procedure.
- Presence of at least 1 ECG abnormality at hospital discharge (QRS ≥120 ms OR PR ≥200 ms)
Who cannot join
- Pacemaker implantation (pre- TAVI or during hospitalization after the procedure).
- TAVI valve-in-valve procedure
- Any complication or logistic reason precluding hospital discharge ≤72 hrs following the TAVI procedure.
- Impossibility to obtain signed informed consent.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site
Institut universitaire de cardiologie et de pneumologie de Québec - UL
Québec, Quebec, G1Y 4G5
Emilie Pelletier beaumont, MSc, 4186568711 ext. 3929, emilie.pelletier-beaumont@criucpq.ulaval.ca
Josep Rodes-Cabau, MD, PhD
About this study
Official title: Systematic Ambulatory ECG Monitoring Following TAVI: A Prospective Randomized Trial.
This multicenter, prospective, randomized superiority trial will evaluate whether systematic 14-day ambulatory ECG monitoring following hospital discharge after transcatheter aortic valve implantation (TAVI) reduces the risk of sudden death, symptomatic arrhythmic events, or stroke within 1 year compared with standard post-discharge care. Patients undergoing successful TAVI without permanent pacemaker implantation and presenting with at least one ECG conduction abnormality at hospital discharge will be randomized to receive either ambulatory ECG monitoring or standard follow-up. All participants will undergo routine clinical follow-up at 30 days and 1 year after TAVI.
Read the detailed description
Transcatheter aortic valve implantation (TAVI) is an established treatment for severe aortic stenosis. Despite advances in transcatheter heart valve technology and procedural techniques, conduction disturbances remain among the most frequent complications following TAVI. High-grade atrioventricular block, complete heart block, and new-onset bundle branch block may occur after the procedure and can lead to delayed permanent pacemaker implantation or life-threatening arrhythmic events. The increasing adoption of minimalist TAVI pathways with hospital discharge within 24-72 hours raises concerns that clinically significant arrhythmias may develop after discharge and remain undetected.
Ambulatory electrocardiographic (ECG) monitoring provides continuous rhythm surveillance during daily activities and enables the early detection of both symptomatic and asymptomatic bradyarrhythmias and tachyarrhythmias. Previous observational studies have demonstrated that clinically significant bradyarrhythmias occur in approximately 5-10% of patients during the first weeks after TAVI, particularly among those with baseline or new-onset conduction abnormalities. Ambulatory ECG monitoring has also identified previously unrecognized atrial fibrillation, allowing timely initiation of anticoagulation therapy in patients at high risk of thromboembolic events.
Although several prospective studies have evaluated ambulatory ECG monitoring after TAVI, most have been observational and were designed primarily to describe the incidence of post-procedural arrhythmias rather than to assess their impact on clinical outcomes. Preliminary evidence from the RECORD pilot study suggested that systematic ambulatory ECG monitoring after hospital discharge was associated with earlier identification and treatment of clinically significant arrhythmias and a reduction in the composite of sudden death, symptomatic arrhythmic events, and stroke during 1-year follow-up, with the greatest benefit observed among patients with conduction abnormalities at hospital discharge.
This randomized trial has been designed to provide definitive evidence regarding the clinical value of systematic ambulatory ECG monitoring after TAVI in patients at increased risk of post-procedural conduction disturbances. The study will evaluate whether early detection and management of clinically significant arrhythmias can improve clinical outcomes during the year following the procedure.
- Conditions
- Aortic Stenosis, Conduction Disturbances
- Being tested
- Ambulatory ECG monitoring
- Keywords
- TAVI, Ambulatory Electrocardiographic Monitoring
- Medical subject headings
- Aortic Valve Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ambulatory ECG monitoringDevice
Participants randomized to the intervention arm will undergo systematic ambulatory ECG monitoring at hospital discharge following the TAVI procedure. A wearable ambulatory ECG monitoring device will be applied for continuous rhythm monitoring during a 14-day period. The device will allow detection of clinically significant bradyarrhythmias and tachyarrhythmias. Detected arrhythmic events will be reviewed by the study team, and appropriate clinical management, including further evaluation or therapeutic intervention, will be performed according to the nature of the detected abnormality and standard clinical practice.
| Study group | Role | What they receive |
|---|---|---|
| Ambulatory ECG monitoring | Experimental | Participants will undergo ambulatory ECG monitoring at hospital discharge following TAVI. Continuous ECG monitoring will be performed for 14 days using an ambulatory ECG monitoring device. Clinically significant bradyarrhythmias or tachyarrhythmias detected during monitoring will be reviewed and managed according to clinical practice, including appropriate therapeutic interventions when indicated. Receives: Device: Ambulatory ECG monitoring |
| Standard care (no ambulatory ECG monitoring device). | No intervention | Participants will receive standard post-TAVI care without systematic ambulatory ECG monitoring at hospital discharge. Clinical follow-up will be performed according to routine practice. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of the combined endpoint (sudden death, symptomatic arrhythmias or stroke)
Composite endpoint including sudden death, symptomatic arrhythmias, or stroke.
Measured: Within the year following the TAVI procedure
Secondary outcomes (25)
Incidence of sudden death
Sudden death
Measured: 1 year after TAVI
Incidence of symptomatic arrhythmias
All symptomatic arrhythmias events
Measured: 1 year after TAVI
Incidence of stroke
All stroke events
Measured: 1 year after TAVI
Incidence of PPI
Number of patients with PPI
Measured: 30 days after TAVI
Incidence of PPI
Number of patients with PPI
Measured: 1 year after TAVI
Incidence of the combined endpoint (sudden death, symptomatic arrhythmias or stroke) at 30 days
Composite endpoint including sudden death, symptomatic arrhythmias, or stroke.
Measured: 30 days after TAVI
Incidence of sudden death
Sudden death
Measured: 30 days after TAVI
Incidence of symptomatic arrhytmias
All symptomatic arrhythmias events
Measured: 30 days after TAVI
Incidence of stroke
All stroke events
Measured: 30 days after TAVI
Incidence of the combined endpoint (sudden death, symptomatic arrhythmias, stroke) according to patient sex
Composite endpoint including sudden death, symptomatic arrhythmias, or stroke, analyzed according to patient sex.
Measured: 1 year after TAVI
Incidence of the combined endpoint of sudden death, symptomatic arrhythmias, or stroke) according to ECG abnormalities
Composite endpoint including sudden death, symptomatic arrhythmias, or stroke, analyzed according to ECG abnormality status (pre-existing versus new-onset after TAVI).
Measured: 1 year after TAVI
Incidence of the combined endpoint according to baseline ECG abnormality type
Composite endpoint (sudden death, symptomatic arrhythmias, or stroke) analyzed according to the type of ECG abnormality present before TAVI.
Measured: 1 year after TAVI
Incidence of sudden death according to baseline ECG abnormality type
Sudden death analyzed according to the type of ECG abnormality present before TAVI.
Measured: 1 year after TAVI
Incidence of symptomatic arrhythmias according to baseline ECG abnormality type
Symptomatic arrhythmias according to the type of ECG abnormality present before TAVI.
Measured: 1 year after TAVI
Incidence of stroke according to baseline ECG abnormality type
Stroke according to the type of ECG abnormality present before TAVI.
Measured: 1 year after TAVI
Incidence of the combined endpoint according to discharge ECG abnormality type
Composite endpoint (sudden death, symptomatic arrhythmias, or stroke) according to the type of ECG abnormality present at hospital discharge.
Measured: 1 year after TAVI
Incidence of sudden death according to discharge ECG abnormality type
Sudden death according to the type of ECG abnormality present at hospital discharge.
Measured: 1 year after TAVI
Incidence of symptomatic arrhythmias according to discharge ECG abnormality type
Symptomatic arrhythmias according to the type of ECG abnormality present at hospital discharge.
Measured: 1 year after TAVI
Incidence of stroke according to discharge ECG abnormality type
Stroke according to the type of ECG abnormality present at hospital discharge.
Measured: 1 year after TAVI
Change in quality of life
Quality of life assessed using the EQ-5D-5L questionnaire.
Measured: Baseline to 1 year after TAVI
Percentage of ventricular pacing
Ventricular pacing burden in participants with permanent pacemakers.
Measured: 1 year after TAVI
Incidence of all-cause mortality
All-cause mortality
Measured: 30 days after TAVI
Incidence of cardiovascular mortality
Cardiovascular mortality
Measured: 30 days after TAVI
Incidence of all-cause mortality
All cause mortality
Measured: 1 year after TAVI
Incidence of cardiovasculare mortality
Cardiovascular mortality
Measured: 1 year after TAVI
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2026
- Study startAug 2026 (estimated)
- Primary completionDec 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (28)Papers the sponsor has linked to this study.
- Other trials for Aortic StenosisStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled trial comparing AECG monitoring for 14 days, vs. no AECG monitoring in patients undergoing succesfull TAVI.
- Masking
- None (open label)
- Enrolment
- 754 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institut universitaire de cardiologie et de pneumologie de Québec, University Laval
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Josep Rodes-Cabau, Institut universitaire de cardiologie et de pneumologie de Québec, University Laval
- Investigators
- Josep Rodes-Cabau, MSc, Principal investigator, Fondation IUCPQ
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07739316
- Sponsor's protocol ID
- RECORDII- MP-10-2026-4441
- Acronym
- RECORDII
- Status last verified
- Jul 2026
- First submitted
- 21 Jul 2026
- Last updated
- 31 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: A decision regarding IPD sharing has not yet been made. Following study completion, requests for access to de-identified individual participant data may be considered by the sponsor on a case-by-case basis, subject to ethical, legal, and institutional requirements.
Publications
Priori SG, Blomstrom-Lundqvist C, Mazzanti A, Blom N, Borggrefe M, Camm J, Elliott PM, Fitzsimons D, Hatala R, Hindricks G, Kirchhof P, Kjeldsen K, Kuck KH, Hernandez-Madrid A, Nikolaou N, Norekval TM, Spaulding C, Van Veldhuisen DJ; ESC Scientific Document Group. 2015 ESC Guidelines for the management of patients with ventricular arrhythmias and the prevention of sudden cardiac death: The Task Force for the Management of Patients with Ventricular Arrhythmias and the Prevention of Sudden Cardiac Death of the European Society of Cardiology (ESC). Endorsed by: Association for European Paediatric and Congenital Cardiology (AEPC). Eur Heart J. 2015 Nov 1;36(41):2793-2867. doi: 10.1093/eurheartj/ehv316. Epub 2015 Aug 29. No abstract available.
PubMed 26320108Al-Khatib SM, Stevenson WG, Ackerman MJ, Bryant WJ, Callans DJ, Curtis AB, Deal BJ, Dickfeld T, Field ME, Fonarow GC, Gillis AM, Granger CB, Hammill SC, Hlatky MA, Joglar JA, Kay GN, Matlock DD, Myerburg RJ, Page RL. 2017 AHA/ACC/HRS Guideline for Management of Patients With Ventricular Arrhythmias and the Prevention of Sudden Cardiac Death: Executive Summary: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines and the Heart Rhythm Society. Circulation. 2018 Sep 25;138(13):e210-e271. doi: 10.1161/CIR.0000000000000548. No abstract available.
PubMed 29084733Kaplan RM, Koehler J, Ziegler PD, Sarkar S, Zweibel S, Passman RS. Stroke Risk as a Function of Atrial Fibrillation Duration and CHA2DS2-VASc Score. Circulation. 2019 Nov 12;140(20):1639-1646. doi: 10.1161/CIRCULATIONAHA.119.041303. Epub 2019 Sep 30.
PubMed 31564126Writing Committee Members; Joglar JA, Chung MK, Armbruster AL, Benjamin EJ, Chyou JY, Cronin EM, Deswal A, Eckhardt LL, Goldberger ZD, Gopinathannair R, Gorenek B, Hess PL, Hlatky M, Hogan G, Ibeh C, Indik JH, Kido K, Kusumoto F, Link MS, Linta KT, Marcus GM, McCarthy PM, Patel N, Patton KK, Perez MV, Piccini JP, Russo AM, Sanders P, Streur MM, Thomas KL, Times S, Tisdale JE, Valente AM, Van Wagoner DR. 2023 ACC/AHA/ACCP/HRS Guideline for the Diagnosis and Management of Atrial Fibrillation: A Report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines. J Am Coll Cardiol. 2024 Jan 2;83(1):109-279. doi: 10.1016/j.jacc.2023.08.017. Epub 2023 Nov 30.
PubMed 38043043Kusumoto FM, Schoenfeld MH, Barrett C, Edgerton JR, Ellenbogen KA, Gold MR, Goldschlager NF, Hamilton RM, Joglar JA, Kim RJ, Lee R, Marine JE, McLeod CJ, Oken KR, Patton KK, Pellegrini CN, Selzman KA, Thompson A, Varosy PD. 2018 ACC/AHA/HRS Guideline on the Evaluation and Management of Patients With Bradycardia and Cardiac Conduction Delay: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines and the Heart Rhythm Society. J Am Coll Cardiol. 2019 Aug 20;74(7):e51-e156. doi: 10.1016/j.jacc.2018.10.044. Epub 2018 Nov 6. No abstract available.
PubMed 30412709Nuche J, Soliman F, Chavarria J, Okoh AK, Alvarado Mora H, Nault I, Natarajan MK, Russo M, Philippon F, Rodes-Cabau J. New-onset atrial fibrillation detected by ambulatory ECG monitoring after transcatheter aortic valve implantation. EuroIntervention. 2024 May 10;20(9):591-601. doi: 10.4244/EIJ-D-23-01014.
PubMed 38726722Muntane-Carol G, 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 Hernandez JM, Asmarats L, Pelletier-Beaumont E, Philippon F, Rodes-Cabau J. Arrhythmic burden in patients with new-onset persistent left bundle branch block after transcatheter aortic valve replacement: 2-year results of the MARE study. Europace. 2021 Feb 5;23(2):254-263. doi: 10.1093/europace/euaa213.
PubMed 33083813Fischer Q, Urena M, Muntane-Carol G, Alperi A, Nombela-Franco L, Veiga G, Regueiro A, Suc G, Romaguera R, Avanzas P, Tirado-Conte G, de la Torre Hernandez JM, Cepas-Guillen P, Cote M, Philippon F, Rodes-Cabau J. Same-Day Permanent Pacemaker Implantation Following Transcatheter Aortic Valve Replacement. JACC Cardiovasc Interv. 2025 Jul 28;18(14):1776-1785. doi: 10.1016/j.jcin.2025.05.041.
PubMed 40738576Fischer Q, Nombela-Franco L, Muntane-Carol G, Veiga G, Regueiro A, Nazif T, Serra V, Asmarats L, Ribeiro HB, Latib A, Poulin A, Cheema AN, Jimenez-Quevedo P, Gomez-Hospital JA, Gil Ongay A, Ruberti A, Arzamendi D, Brener M, Calabuig A, Scotti A, Gelain MAS, Labinaz M, Cepas-Guillen P, Cote M, Del Portillo JH, Philippon F, Rodes-Cabau J. Risk of delayed atrioventricular block in patients without procedural conduction disturbances during transcatheter aortic valve replacement. Heart Rhythm. 2026 Apr;23(4):955-962. doi: 10.1016/j.hrthm.2025.04.017. Epub 2025 Apr 14.
PubMed 40239910Natarajan MK, Sheth TN, Wijeysundera HC, Chavarria J, Rodes-Cabau J, Velianou JL, Radhakrishnan S, Newman T, Smith A, Wong JA, Schwalm JD, Duong M, Mian RI, Bishop MG, Healey JS. Remote ECG monitoring to reduce complications following transcatheter aortic valve implantations: the Redirect TAVI study. Europace. 2022 Oct 13;24(9):1475-1483. doi: 10.1093/europace/euac042.
PubMed 35699482Muntane-Carol G, Okoh AK, Chen C, Nault I, Kassotis J, Mohammadi S, Coromilas J, Lee LY, Alperi A, Philippon F, Russo MJ, Rodes-Cabau J. Ambulatory Electrocardiographic Monitoring Following Minimalist Transcatheter Aortic Valve Replacement. JACC Cardiovasc Interv. 2021 Dec 27;14(24):2711-2722. doi: 10.1016/j.jcin.2021.08.039.
PubMed 34949396Winter JL, Healey JS, Sheth TN, Velianou JL, Schwalm JD, Smith A, Reza S, Natarajan MK. Remote Ambulatory Cardiac Monitoring Before and After Transcatheter Aortic Valve Replacement. CJC Open. 2020 Apr 25;2(5):416-419. doi: 10.1016/j.cjco.2020.04.006. eCollection 2020 Sep.
PubMed 32995727Skaf M, Makki N, Coressel A, Matre N, O'Neill S, Boudoulas K, Rushing G, Lilly SM. Rhythm Disturbances After Transcatheter Aortic Valve Replacement: A Strategy of Surveillance. Cardiovasc Revasc Med. 2020 Apr;21(4):475-478. doi: 10.1016/j.carrev.2019.07.017. Epub 2019 Jul 30. No abstract available.
PubMed 31431323Tian Y, Padmanabhan D, McLeod CJ, Zhang P, Xiao P, Sandhu GS, Greason KL, Gulati R, Nkomo VT, Rihal CS, Polk LE, Sanvick C, Liu XP, Friedman PA, Cha YM. Utility of 30-Day Continuous Ambulatory Monitoring to Identify Patients With Delayed Occurrence of Atrioventricular Block After Transcatheter Aortic Valve Replacement. Circ Cardiovasc Interv. 2019 Dec;12(12):e007635. doi: 10.1161/CIRCINTERVENTIONS.118.007635. Epub 2019 Dec 13.
PubMed 31833417Ream K, Sandhu A, Valle J, Weber R, Kaizer A, Wiktor DM, Borne RT, Tumolo AZ, Kunkel M, Zipse MM, Schuller J, Tompkins C, Rosenberg M, Nguyen DT, Cleveland JC Jr, Fullerton D, Carroll JD, Messenger J, Sauer WH, Aleong RG, Tzou WS. Ambulatory Rhythm Monitoring to Detect Late High-Grade Atrioventricular Block Following Transcatheter Aortic Valve Replacement. J Am Coll Cardiol. 2019 May 28;73(20):2538-2547. doi: 10.1016/j.jacc.2019.02.068.
PubMed 31118148