Physiological PacingLEVEL-ATNCT04054895

LEft VEntricuLar Activation Time Shortening With Physiological Pacing vs Biventricular Resynchronization Therapy

A study testing Lead placed in the His-Purkinje system in order to achieve QRS shortening. and Lead is placed in a tributary of the coronary sinus. in people with Physiological Pacing and Resynchronization Therapy, run by Josep Lluis Mont Girbau at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The LEVEL-AT Trial (LEft VEntricuLar Activation Time Shortening with Physiological Pacing vs Biventricular Resynchronization therapy: a randomized study) is a non-inferiority study that aims to determine if physiological pacing could decrease the left ventricular activation time compared with biventricular therapy. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Physiological Pacing, Resynchronization Therapy
What is being tested?: Lead placed in the His-Purkinje system in order to achieve QRS shortening. and Lead is placed in a tributary of the coronary sinus.
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 70 participants
Where: 1 siteSpain
Study dates: 1 Sep 2019to 30 Jun 2022
Phase: Interventional
Are there results?: None posted in the registry

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

The patient must indicate their acceptance to participate in the study by signing an informed consent document.
The patient must be ≥ 18 years of age.
Left bundle branch block, QRS ≥130 and FEVI <=35% (Indication of cardiac resynchronization IA or IB ESC Guidelines). No indication of stimulation for AV block.
Patients with indication of resynchronization therapy for ventricular dysfunction and indication of cardiac stimulation for AV block according to ESC Guidelines (IA ESC Guidelines).
Non-left bundle branch block, QRS ≥150 and FEVI <=35% (Indication of cardiac resynchronization IIaB ESC Guidelines).

Who cannot join

Myocardial infarction, unstable angina or cardiac revascularization during the previous 3 months.
Pregnancy.
Participating currently in a clinical investigation that includes an active treatment.

Trial locations and contacts

1 site in 1 country.

Spain1 site

Hospital Clinic de Barcelona
Barcelona, Select, 08036

Other trials in Spain

About this study

Official title: LEft VEntricuLar Activation Time Shortening With Physiological Pacing vs Biventricular Resynchronization Therapy: a Randomized Study (LEVEL-AT)

Read the detailed description

To date studies have showed that physiological pacing could get similar clinical and echocardiographic response to that obtained with biventricular therapy. Activation time shortening with permanent physiological pacing has not been studied.

This study will randomize 70 patients to a strategy of: biventricular pacing versus physiological pacing.

LEVEL-AT study will analyze the following parameters in the 2 groups: shortening of the QRS, activation time with electrocardiographic imaging, echocardiographic asynchrony and ventricular function and clinical parameters (NYHA functional class, mortality and heart failure hospitalization).

Clinical, electrocardiographic, echocardiographic and electrocardiographic imaging follow-up will be performed for 1 year.

Conditions: Physiological Pacing, Resynchronization Therapy
Being tested: Lead placed in the His-Purkinje system in order to achieve QRS shortening., Lead is placed in a tributary of the coronary sinus.
Keywords: Physiological pacing, Resynchronization therapy, Electrocardiographic imaging

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Lead placed in the His-Purkinje system in order to achieve QRS shortening.Device
Physiologic pacing to achieve QRS shortening. If the patient has indication of stimulation (AV block), a backup lead will be implanted in the right ventricle. All patients will have a lead placed in the right atrium (except those that have permanent atrial fibrillation).
Lead is placed in a tributary of the coronary sinus.Device
Biventricular Resynchronization Therapy is the use of a pacemaker with two endocardial leads placed in the right atrium and right ventricle. The third lead is placed in a tributary of the coronary sinus.

Study groups in NCT04054895
Study group	Role	What they receive
Physiological pacing	Experimental	Pacing the his-purkinje system. Crossover to biventricular CRT will be allowed in the following situations: failed physiological pacing lead implantation; high thresholds (>3.5V / 1ms); no shortening of QRS (shortening <20%) or failure to meet non-selective HBP criteria [Europace. 2019 Oct 9. doi: 10.1093/europace/euz275]. Receives: Device: Lead placed in the His-Purkinje system in order to achieve QRS shortening.
Biventricular resynchronization therapy	Active comparator	Pacing from the right ventricular and coronary sinus leads. Electrocardiographic optimization with fusion-optimized intervals. Crossover from biventricular CRT to physiological pacing will be allowed in the following situations: coronary sinus cannot be cannulated; no lateral or posterolateral branches; or phrenic stimulation. Receives: Device: Lead is placed in a tributary of the coronary sinus.

What is being measured

The primary outcome is the main question the study is designed to answer.

Left ventricular activation time.
Left ventricular activation time measured by eletrocardiographic imaging.
Measured: 45 days

Secondary outcomes (7)

QRS duration.
QRS duration (milliseconds) measured with a 12-lead ECG.
Measured: Implant, 6 months and 12 months.
Left ventricular activation time.
Left ventricular activation time measured by eletrocardiographic imaging
Measured: 6 months and 12 months.
Change in left ventricular function.
Left ventricular ejection fraction measured with Simpson method with echocardiography.
Measured: 6 months and 12 months.
Change in end-systolic volume.
End-systolic volume measured with echocardiography.
Measured: 6 months and 12 months.
Change in NYHA functional class.
NYHA functional class I, II, III, IV.
Measured: 6 months and 12 months.
Hospitalization due to heart failure or mortality (combined endpoint).
Hospitalization: patient hospitalization (yes/no) Mortality: mortality (yes/no)
Measured: 1 year.
Correction of septal flash
Correction of septal flash determined with echocardiography (M mode)
Measured: 15 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Sep 201930 Jun 2022

First posted13 Aug 2019
Study start1 Sep 2019
Primary completion30 Jun 2022
Study completion30 Jun 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Physiological PacingStudies 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, unicentric, simple blind.
Masking: Single blind
Who is masked: Participant
Enrolment: 70 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04054895
Sponsor's protocol ID: LEVEL-AT
Acronym: LEVEL-AT
Status last verified: Aug 2022
First submitted: 7 Aug 2019
Last updated: 4 Aug 2022
Results posted: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Publications

Pujol-Lopez M, Ferro E, Borras R, Garre P, Guasch E, Jimenez-Arjona R, Garcia-Ribas C, Doltra A, Niebla M, Carro E, Roca-Luque I, Guichard JB, Puente JL, Uribe L, Vazquez-Calvo S, Castel MA, Arbelo E, Porta-Sanchez A, Sitges M, Tolosana JM, Mont L. Stepwise application of ECG and electrogram-based criteria to ensure electrical resynchronization with left bundle branch pacing. Europace. 2023 Jun 2;25(6):euad128. doi: 10.1093/europace/euad128.
PubMed 37294671
Pujol-Lopez M, Jimenez-Arjona R, Garre P, Guasch E, Borras R, Doltra A, Ferro E, Garcia-Ribas C, Niebla M, Carro E, Puente JL, Vazquez-Calvo S, Invers-Rubio E, Roca-Luque I, Castel MA, Arbelo E, Sitges M, Brugada J, Tolosana JM, Mont L. Conduction System Pacing vs Biventricular Pacing in Heart Failure and Wide QRS Patients: LEVEL-AT Trial. JACC Clin Electrophysiol. 2022 Nov;8(11):1431-1445. doi: 10.1016/j.jacep.2022.08.001. Epub 2022 Oct 26.
PubMed 36424012

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Bachmann's Bundle Versus Right Atrial Appendage Pacing
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Physiological Pacing for AV Block to Prevent Pacemaker-induced Cardiomyopathy
Conduction System Pacing, Conventional Ventricular Pacing
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PACE Cognition Proof-of-Concept Study
Symptomatic Bradycardia, Cognitive Function
Recruiting
Posterosuperior Bundle Pacing for Prevention of Atrial Fibrillation in Patients With Sinus Node Dysfunction
Pacing Therapy, Cardiac Pacing
Recruiting
"Physiological vs Right Ventricular Pacing Outcome Trial Evaluated for bradyCardia Treatment" (PROTECT-HF)
Bradycardia, Pacing

All Physiological Pacing trials

Study at a glance

From the registry record, last updated by the sponsor on 4 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: LEft VEntricuLar Activation Time Shortening With Physiological Pacing vs Biventricular Resynchronization Therapy: a Randomized Study (LEVEL-AT)
ClinicalTrials.gov ID: NCT04054895
Acronym / sponsor ID: LEVEL-AT / LEVEL-AT
Conditions: Physiological Pacing, Resynchronization Therapy
Keywords: Physiological pacing, Resynchronization therapy, Electrocardiographic imaging
Study type: Interventional
Recruitment status: Completed
Enrolment: 70 participants (actual)
Lead sponsor: Josep Lluis Mont GirbauUniversity, hospital or other
Collaborators: Institut d'Investigacions Biomèdiques August Pi i Sunyer, Consorcio Centro de Investigación Biomédica en Red (CIBER)
Study start: 1 Sep 2019 (actual)
Primary completion: 30 Jun 2022 (actual)
Study completion: 30 Jun 2022 (actual)
First posted: 13 Aug 2019 (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.

Detailed description

This study will randomize 70 patients to a strategy of: biventricular pacing versus physiological pacing.

Clinical, electrocardiographic, echocardiographic and electrocardiographic imaging follow-up will be performed for 1 year.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 2
Model description: Randomized, unicentric, simple blind.

Arm	Type	Receives
Physiological pacing	Experimental	Device: Lead placed in the His-Purkinje system in order to achieve QRS shortening.Pacing the his-purkinje system. Crossover to biventricular CRT will be allowed in the following situations: failed physiological pacing lead implantation; high thresholds (>3.5V / 1ms); no shortening of QRS (shortening <20%) or failure to meet non-selective HBP criteria [Europace. 2019 Oct 9. doi: 10.1093/europace/euz275].
Biventricular resynchronization therapy	Active comparator	Device: Lead is placed in a tributary of the coronary sinus.Pacing from the right ventricular and coronary sinus leads. Electrocardiographic optimization with fusion-optimized intervals. Crossover from biventricular CRT to physiological pacing will be allowed in the following situations: coronary sinus cannot be cannulated; no lateral or posterolateral branches; or phrenic stimulation.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

The patient must indicate their acceptance to participate in the study by signing an informed consent document.
The patient must be ≥ 18 years of age.
Left bundle branch block, QRS ≥130 and FEVI <=35% (Indication of cardiac resynchronization IA or IB ESC Guidelines). No indication of stimulation for AV block.
Patients with indication of resynchronization therapy for ventricular dysfunction and indication of cardiac stimulation for AV block according to ESC Guidelines (IA ESC Guidelines).
Non-left bundle branch block, QRS ≥150 and FEVI <=35% (Indication of cardiac resynchronization IIaB ESC Guidelines).

Key exclusion criteria (3 listed)

Myocardial infarction, unstable angina or cardiac revascularization during the previous 3 months.
Pregnancy.
Participating currently in a clinical investigation that includes an active treatment.

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
Lead placed in the His-Purkinje system in order to achieve QRS shortening.Physiologic pacing to achieve QRS shortening. If the patient has indication of stimulation (AV block), a backup lead will be implanted in the right ventricle. All patients will have a lead placed in the right atrium (except those that have permanent atrial fibrillation).	Device	Physiological pacing
Lead is placed in a tributary of the coronary sinus.Biventricular Resynchronization Therapy is the use of a pacemaker with two endocardial leads placed in the right atrium and right ventricle. The third lead is placed in a tributary of the coronary sinus.	Device	Biventricular resynchronization therapy

Primary outcome

Left ventricular activation time.
Time frame: 45 days
Left ventricular activation time measured by eletrocardiographic imaging.

7 secondary outcomes

QRS duration.
Time frame: Implant, 6 months and 12 months.
Left ventricular activation time.
Time frame: 6 months and 12 months.
Change in left ventricular function.
Time frame: 6 months and 12 months.
Change in end-systolic volume.
Time frame: 6 months and 12 months.
Change in NYHA functional class.
Time frame: 6 months and 12 months.
Hospitalization due to heart failure or mortality (combined endpoint).
Time frame: 1 year.
Correction of septal flash
Time frame: 15 days

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2022.
Derived from this study: PubMed 37294671Pujol-Lopez M, Ferro E, Borras R, Garre P, Guasch E, Jimenez-Arjona R, Garcia-Ribas C, Doltra A, Niebla M, Carro E, Roca-Luque I, Guichard JB, Puente JL, Uribe L, Vazquez-Calvo S, Castel MA, Arbelo E, Porta-Sanchez A, Sitges M, Tolosana JM, Mont L. Stepwise application of ECG and electrogram-based criteria to ensure electrical resynchronization with left bundle branch pacing. Europace. 2023 Jun 2;25(6):euad128. doi: 10.1093/europace/euad128.
Derived from this study: PubMed 36424012Pujol-Lopez M, Jimenez-Arjona R, Garre P, Guasch E, Borras R, Doltra A, Ferro E, Garcia-Ribas C, Niebla M, Carro E, Puente JL, Vazquez-Calvo S, Invers-Rubio E, Roca-Luque I, Castel MA, Arbelo E, Sitges M, Brugada J, Tolosana JM, Mont L. Conduction System Pacing vs Biventricular Pacing in Heart Failure and Wide QRS Patients: LEVEL-AT Trial. JACC Clin Electrophysiol. 2022 Nov;8(11):1431-1445. doi: 10.1016/j.jacep.2022.08.001. Epub 2022 Oct 26.
Individual participant dataSharing planned: No

Related trials for Physiological Pacing

Recruiting
Bachmann's Bundle Versus Right Atrial Appendage Pacing
Atrial Fibrillation (AF)
Active, not recruiting
Physiological Pacing for AV Block to Prevent Pacemaker-induced Cardiomyopathy
Conduction System Pacing, Conventional Ventricular Pacing
Not yet recruiting
PACE Cognition Proof-of-Concept Study
Symptomatic Bradycardia, Cognitive Function
Recruiting
Posterosuperior Bundle Pacing for Prevention of Atrial Fibrillation in Patients With Sinus Node Dysfunction
Pacing Therapy, Cardiac Pacing
Recruiting
"Physiological vs Right Ventricular Pacing Outcome Trial Evaluated for bradyCardia Treatment" (PROTECT-HF)
Bradycardia, Pacing

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. This study is not recruiting at the moment.

Jose M Tolosana, MD, PhD principal investigator

Hospital Clinic of Barcelona

Margarida Pujol Lopez, MD principal investigator

Hospital Clinic of Barcelona

Lluis Mont Girbau, MD, PhD study director

Hospital Clinic of Barcelona

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 5 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: finished, as of the sponsor's last update on 4 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Left ventricular activation time. (time frame: 45 days). 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 NCT04054895, which also lists 2 linked publications.

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 4 Aug 2022.