Left Bundle-Branch BlockCOME-TAVINCT03303612
Clinical Monitoring Strategy Versus Electrophysiology-guided Algorithmic Approach With a New LBBB After TAVI
A study testing Pacemaker implant and Transcutaneous cardiac monitor in people with Left Bundle-Branch Block and Aortic Valve Stenosis, run by Montreal Heart Institute at 10 sites in 2 countries.
Trial summary
The primary hypothesis of the proposed study is that an electrophysiology-based algorithmic approach is superior to standard clinical follow-up with 30-day monitoring in reducing the combined endpoint of syncope, hospitalization, and death in patients in patients with new of left bundle branch block following… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Left Bundle-Branch Block, Aortic Valve Stenosis
- What is being tested?
- Pacemaker implant and Transcutaneous cardiac monitor
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 10 sitesin 2 countries
- Study dates
- 15 Oct 2017to Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Informed consent to participate
- Persistent new-onset LBBB after TAVI implantation (i.e. present at day 2)
Who cannot join
- Prior pacemaker or implantable cardioverter-defibrillator
- Pre-existing right bundle branch block (RBBB) or LBBB (i.e., prior to TAVI)
- Class I or IIA indication for PPM implantation according to management guidelines
Trial locations and contacts
10 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
10 sites in 2 countries
Canada9 sites, 9 recruiting
- Recruiting
Mazankowski Alberta Heart Institute
Edmonton, Alberta
Kenneth Quadros, MD
- Recruiting
QEII Health Sciences Center
Halifax, Nova Scotia
Ratika Parkash, MD
- Recruiting
Hamilton Health Sciences Corporation
Hamilton, Ontario
Madhu Natarajan, MD
- Recruiting
London Health Sciences Center (LHSC)
London, Ontario
Jaimie Manlucu, MD
- Recruiting
Montreal Heart Institute
Montreal, Quebec, H1T1C8
lena Rivard, MD, MSc, 514-376-3330 ext. 2120, lena.rivard@icm-mhi.org
Caroline Girard, 514-376-3330 ext. 4058, caroline.girard@icm-mhi.org
- Recruiting
CIUSSS du Nord de l'Île de Mtl
Montreal, Quebec
Rémi Kouz, MD
- Recruiting
University of Ottawa Heart Institute (UOHI)
Ottawa, Ontario
Mehrdad Golian, MD
- Not yet recruiting
New Brunswick Heart Center
Saint John, New Brunswick
Satish Toal, MD
- Recruiting
Centre hospitalier universitaire de Sherbrooke
Sherbrooke, Quebec, Canada, J1J 3H5
Benoît Daneault, MD
France1 site, 1 recruiting
- Not yet recruiting
Centre Hospitalier Universitaire de Nantes
Nantes, Cedex 01
Jean-Baptiste Gourraud, MD
About this study
Official title: Comparison of a Clinical Monitoring Strategy Versus Electrophysiology-guided Algorithmic Approach in Patients With a New Left Bundle Branch Block After Transcatheter Aortic Valve Implantation (TAVI) a Bayesian Randomized Trial (COME-TAVI)
The primary hypothesis of the proposed study is that an electrophysiology-based algorithmic approach is superior to standard clinical follow-up with 30-day monitoring in reducing the combined endpoint of syncope, hospitalization, and death in patients in patients with new of left bundle branch block following transcatheter aortic valve implantation (TAVI).
Read the detailed description
The study population consists of pacemaker-free patients that are 18 years or older undergoing a TAVI with new onset left bundle branch block. Patient consent is required.
Patients who meet inclusion/exclusion criteria will be randomized to an EP-based algorithmic approach (Group 1) or standard clinical follow-up with 30-day transcutaneous cardiac monitoring (Group 2), as defined below. Based on Bayesian approaches, the probability of being assigned to either group is unknown, as it will be adjusted throughout the study.
- Conditions
- Left Bundle-Branch Block, Aortic Valve Stenosis
- Being tested
- Pacemaker implant, Transcutaneous cardiac monitor
- Medical subject headings
- Bundle-Branch Block, Aortic Valve Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pacemaker implantDevice
Patient will be in the electrophysiology laboratory. The doctor will freeze the groin area and a medication may be given to help the patient relax. A catheter will be inserted into the groin up to the heart and the heart's electrical system will be recorded.
Transcutaneous cardiac monitorDevice
Transcutaneous cardiac patches will allow continuous electrocardiographic monitoring for a 30-day period. For the first randomized patients at the Montreal Heart Institute, Icentia was used and then was changed to a m-Health® device which allows continuous cardiac monitoring. The PocketECG from m-Health® is attached to 3 electrodes on the chest and contains a SIM card that transmits to a server located in Burlington, Ontario .The COME-TAVI coordinating center and the associated site will be informed rapidly of any events that occur . These events include:
Ventricular fibrillation; Sustained ventricular tachycardia Any RR interval >5 sec; Third-degree AV block or Mobitz 2 AV block;
| Study group | Role | What they receive |
|---|---|---|
| EP-based approach/pacemaker implant | Other | Subjects will undergo an EP study prior to hospital discharge and will receive a pacemaker implantation if the HV interval is ≥65 msec.
In the case where the electrical slowdown is not confirmed by the electrophysiological study, the participant will not have a pacemaker implantation. Receives: Device: Pacemaker implant |
| Compared transcutaneous cardiac monitor | Other | Subjects will undergo a minimum of 72 hour ECG monitoring in hospital and receive transcutaneous monitoring prior to hospital discharge for a duration of 30 days. Receives: Device: Transcutaneous cardiac monitor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with cardiovascular hospitalization, and/or syncope, and/or death after TAVI.
This is the number of participants who experienced cardiovascular hospitalizations, and/or syncope, and/or death after TAVI.
Measured: 12 months
Secondary outcomes (7)
Number of participants with cardiovascular hospitalizations.
This is the number of participants who were hospitalized for cardiovascular reasons within one-year post-TAVI.
Measured: 12 months
Number of participants with hospitalisations (Total)
This is the number of participants who were hospitalized one-year post-TAVI.
Measured: 12 months
Number of participants with emergency visits.
This is the number of participants who had emergency visits after TAVI.
Measured: 12 months
Number of participants experiencing syncope
This is the number of participants who experienced syncope after TAVI.
Measured: 12 months
Cost-effectiveness of EP-guided procedure compared to cardiac monitoring [incremental cost effectiveness ratio (ICER)].
This is the incremental cost effectiveness ratio (ICER) for one strategy compared to the other.
Measured: 12 months
Number of procedural complications in the group of EP-guided procedure compared to the group of cardiac monitoring.
This is the number of procedural complications in the group of EP-guided approach compared to cardiac monitoring within 30 days.
Measured: 30 days
Number of atrio-ventricular blocks in the group of EP-guided procedure compared to the group of transcutaneous cardiac monitoring.
This is the number of atrio-ventricular blocks in the EP-guided procedure group compared to the transcutaneous cardiac monitoring group within 12 months of TAVI
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2017
- Study start15 Oct 2017
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Left Bundle-Branch BlockStudies 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
- Masking
- None (open label)
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Montreal Heart Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Léna Rivard, MD, MSC, Principal investigator, Montreal Heart Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03303612
- Sponsor's protocol ID
- ICM#2015-1949
- Acronym
- COME-TAVI
- Status last verified
- Oct 2026
- First submitted
- 6 May 2016
- Last updated
- 14 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Rivard L, Nault I, Krahn AD, Daneault B, Roux JF, Natarajan M, Healey JS, Quadros K, Sandhu RK, Kouz R, Greiss I, Leong-Sit P, Gourraud JB, Ben Ali W, Asgar A, Aguilar M, Bonan R, Cadrin-Tourigny J, Cartier R, Dorval JF, Dubuc M, Durrleman N, Dyrda K, Guerra P, Ibrahim M, Ibrahim R, Macle L, Mondesert B, Moss E, Raymond-Paquin A, Roy D, Tadros R, Thibault B, Talajic M, Nozza A, Guertin MC, Khairy P. Rationale and Design of the Randomized Bayesian Multicenter COME-TAVI Trial in Patients With a New Onset Left Bundle Branch Block. CJC Open. 2023 Jul 13;5(8):611-618. doi: 10.1016/j.cjco.2023.05.009. eCollection 2023 Aug.
PubMed 37720184
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of a Clinical Monitoring Strategy Versus Electrophysiology-guided Algorithmic Approach in Patients With a New Left Bundle Branch Block After Transcatheter Aortic Valve Implantation (TAVI) a Bayesian Randomized Trial (COME-TAVI)
- ClinicalTrials.gov ID
- NCT03303612
- Acronym / sponsor ID
- COME-TAVI / ICM#2015-1949
- Conditions
- Left Bundle-Branch Block, Aortic Valve Stenosis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Montreal Heart InstituteUniversity, hospital or other
- Study start
- 15 Oct 2017 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 6 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary hypothesis of the proposed study is that an electrophysiology-based algorithmic approach is superior to standard clinical follow-up with 30-day monitoring in reducing the combined endpoint of syncope, hospitalization, and death in patients in patients with new of left bundle branch block following transcatheter aortic valve implantation (TAVI).
Detailed description
The study population consists of pacemaker-free patients that are 18 years or older undergoing a TAVI with new onset left bundle branch block. Patient consent is required.
Patients who meet inclusion/exclusion criteria will be randomized to an EP-based algorithmic approach (Group 1) or standard clinical follow-up with 30-day transcutaneous cardiac monitoring (Group 2), as defined below. Based on Bayesian approaches, the probability of being assigned to either group is unknown, as it will be adjusted throughout the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EP-based approach/pacemaker implant | Other | Device: Pacemaker implantSubjects will undergo an EP study prior to hospital discharge and will receive a pacemaker implantation if the HV interval is ≥65 msec. In the case where the electrical slowdown is not confirmed by the electrophysiological study, the participant will not have a pacemaker implantation. |
| Compared transcutaneous cardiac monitor | Other | Device: Transcutaneous cardiac monitorSubjects will undergo a minimum of 72 hour ECG monitoring in hospital and receive transcutaneous monitoring prior to hospital discharge for a duration of 30 days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age ≥18 years
- Informed consent to participate
- Persistent new-onset LBBB after TAVI implantation (i.e. present at day 2)
Key exclusion criteria (3 listed)
- Prior pacemaker or implantable cardioverter-defibrillator
- Pre-existing right bundle branch block (RBBB) or LBBB (i.e., prior to TAVI)
- Class I or IIA indication for PPM implantation according to management guidelines
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pacemaker implantPatient will be in the electrophysiology laboratory. The doctor will freeze the groin area and a medication may be given to help the patient relax. A catheter will be inserted into the groin up to the heart and the heart's electrical system will be recorded. | Device | EP-based approach/pacemaker implant |
| Transcutaneous cardiac monitorTranscutaneous cardiac patches will allow continuous electrocardiographic monitoring for a 30-day period. For the first randomized patients at the Montreal Heart Institute, Icentia was used and then was changed to a m-Health® device which allows continuous cardiac monitoring. The PocketECG from m-Health® is attached to 3 electrodes on the chest and contains a SIM card that transmits to a server located in Burlington, Ontario .The COME-TAVI coordinating center and the associated site will be informed rapidly of any events that occur . These events include: Ventricular fibrillation; Sustained ventricular tachycardia Any RR interval >5 sec; Third-degree AV block or Mobitz 2 AV block; | Device | Compared transcutaneous cardiac monitor |
Primary outcome
Number of patients with cardiovascular hospitalization, and/or syncope, and/or death after TAVI.
Time frame: 12 months
This is the number of participants who experienced cardiovascular hospitalizations, and/or syncope, and/or death after TAVI.
7 secondary outcomes
Number of participants with cardiovascular hospitalizations.
Time frame: 12 months
Number of participants with hospitalisations (Total)
Time frame: 12 months
Number of participants with emergency visits.
Time frame: 12 months
Number of participants experiencing syncope
Time frame: 12 months
Cost-effectiveness of EP-guided procedure compared to cardiac monitoring [incremental cost effectiveness ratio (ICER)].
Time frame: 12 months
Number of procedural complications in the group of EP-guided procedure compared to the group of cardiac monitoring.
Time frame: 30 days
Number of atrio-ventricular blocks in the group of EP-guided procedure compared to the group of transcutaneous cardiac monitoring.
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2026.
- Derived from this study: PubMed 37720184Rivard L, Nault I, Krahn AD, Daneault B, Roux JF, Natarajan M, Healey JS, Quadros K, Sandhu RK, Kouz R, Greiss I, Leong-Sit P, Gourraud JB, Ben Ali W, Asgar A, Aguilar M, Bonan R, Cadrin-Tourigny J, Cartier R, Dorval JF, Dubuc M, Durrleman N, Dyrda K, Guerra P, Ibrahim M, Ibrahim R, Macle L, Mondesert B, Moss E, Raymond-Paquin A, Roy D, Tadros R, Thibault B, Talajic M, Nozza A, Guertin MC, Khairy P. Rationale and Design of the Randomized Bayesian Multicenter COME-TAVI Trial in Patients With a New Onset Left Bundle Branch Block. CJC Open. 2023 Jul 13;5(8):611-618. doi: 10.1016/j.cjco.2023.05.009. eCollection 2023 Aug.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Léna Rivard, MD, MSC principal investigator
Montreal Heart Institute
10 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pacemaker implant and Transcutaneous cardiac monitor in people with Left Bundle-Branch Block and Aortic Valve Stenosis, run by Montreal Heart Institute at 10 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Canada, France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Léna Rivard, MD, MSc (514-376-3330 ext. 2120, lena.rivard@umontreal.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients with cardiovascular hospitalization, and/or syncope, and/or death after TAVI. (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03303612, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2026.