Systematic Ambulatory ECG Monitoring Following TAVI (RECORDII)

July 27, 2026 updated by: Josep Rodes-Cabau, Institut universitaire de cardiologie et de pneumologie de Québec, University Laval

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
754

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Canada
    • Quebec
      • Québec, Quebec, Canada, G1Y 4G5
        • Institut universitaire de cardiologie et de pneumologie de Québec - UL
        • Contact:
        • Principal Investigator:
          • Josep Rodés-Cabau, MD, PhD
        • Sub-Investigator:
          • Francois Philippon, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Ambulatory ECG monitoring
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.
Device: Ambulatory ECG monitoring
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.
No Intervention: Standard care (no ambulatory ECG monitoring device).
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 the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Rate of the combined endpoint (sudden death, symptomatic arrhythmias or stroke)
Time Frame: Within the year following the TAVI procedure
Composite endpoint including sudden death, symptomatic arrhythmias, or stroke.
Within the year following the TAVI procedure

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Incidence of sudden death
Time Frame: 1 year after TAVI
Sudden death
1 year after TAVI
Incidence of symptomatic arrhythmias
Time Frame: 1 year after TAVI
All symptomatic arrhythmias events
1 year after TAVI
Incidence of stroke
Time Frame: 1 year after TAVI
All stroke events
1 year after TAVI
Incidence of PPI
Time Frame: 30 days after TAVI
Number of patients with PPI
30 days after TAVI
Incidence of PPI
Time Frame: 1 year after TAVI
Number of patients with PPI
1 year after TAVI
Incidence of the combined endpoint (sudden death, symptomatic arrhythmias or stroke) at 30 days
Time Frame: 30 days after TAVI
Composite endpoint including sudden death, symptomatic arrhythmias, or stroke.
30 days after TAVI
Incidence of sudden death
Time Frame: 30 days after TAVI
Sudden death
30 days after TAVI
Incidence of symptomatic arrhytmias
Time Frame: 30 days after TAVI
All symptomatic arrhythmias events
30 days after TAVI
Incidence of stroke
Time Frame: 30 days after TAVI
All stroke events
30 days after TAVI
Incidence of the combined endpoint (sudden death, symptomatic arrhythmias, stroke) according to patient sex
Time Frame: 1 year after TAVI
Composite endpoint including sudden death, symptomatic arrhythmias, or stroke, analyzed according to patient sex.
1 year after TAVI
Incidence of the combined endpoint of sudden death, symptomatic arrhythmias, or stroke) according to ECG abnormalities
Time Frame: 1 year after TAVI
Composite endpoint including sudden death, symptomatic arrhythmias, or stroke, analyzed according to ECG abnormality status (pre-existing versus new-onset after TAVI).
1 year after TAVI
Incidence of the combined endpoint according to baseline ECG abnormality type
Time Frame: 1 year after TAVI
Composite endpoint (sudden death, symptomatic arrhythmias, or stroke) analyzed according to the type of ECG abnormality present before TAVI.
1 year after TAVI
Incidence of sudden death according to baseline ECG abnormality type
Time Frame: 1 year after TAVI
Sudden death analyzed according to the type of ECG abnormality present before TAVI.
1 year after TAVI
Incidence of symptomatic arrhythmias according to baseline ECG abnormality type
Time Frame: 1 year after TAVI
Symptomatic arrhythmias according to the type of ECG abnormality present before TAVI.
1 year after TAVI
Incidence of stroke according to baseline ECG abnormality type
Time Frame: 1 year after TAVI
Stroke according to the type of ECG abnormality present before TAVI.
1 year after TAVI
Incidence of the combined endpoint according to discharge ECG abnormality type
Time Frame: 1 year after TAVI
Composite endpoint (sudden death, symptomatic arrhythmias, or stroke) according to the type of ECG abnormality present at hospital discharge.
1 year after TAVI
Incidence of sudden death according to discharge ECG abnormality type
Time Frame: 1 year after TAVI
Sudden death according to the type of ECG abnormality present at hospital discharge.
1 year after TAVI
Incidence of symptomatic arrhythmias according to discharge ECG abnormality type
Time Frame: 1 year after TAVI
Symptomatic arrhythmias according to the type of ECG abnormality present at hospital discharge.
1 year after TAVI
Incidence of stroke according to discharge ECG abnormality type
Time Frame: 1 year after TAVI
Stroke according to the type of ECG abnormality present at hospital discharge.
1 year after TAVI
Change in quality of life
Time Frame: Baseline to 1 year after TAVI
Quality of life assessed using the EQ-5D-5L questionnaire.
Baseline to 1 year after TAVI
Percentage of ventricular pacing
Time Frame: 1 year after TAVI
Ventricular pacing burden in participants with permanent pacemakers.
1 year after TAVI
Incidence of all-cause mortality
Time Frame: 30 days after TAVI
All-cause mortality
30 days after TAVI
Incidence of cardiovascular mortality
Time Frame: 30 days after TAVI
Cardiovascular mortality
30 days after TAVI
Incidence of all-cause mortality
Time Frame: 1 year after TAVI
All cause mortality
1 year after TAVI
Incidence of cardiovasculare mortality
Time Frame: 1 year after TAVI
Cardiovascular mortality
1 year after TAVI

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Institut universitaire de cardiologie et de pneumologie de Québec, University Laval

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Josep Rodes-Cabau, MSc, Fondation IUCPQ

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 21, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 27, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 31, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 31, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 27, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • RECORDII- MP-10-2026-4441

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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