Pacing-Induced CardiomyopathyCROSS-LEFT-AFNCT05162716
Cardiac ResynchrOniSation Via Stimulation of the LEFT Bundle in AF Patients.
An observational study of Pacing-Induced Cardiomyopathy, run by Nicolas Clementy, MD, PhD at 1 site in France.
Trial summary
Permanent ventricular pacing may be complicated with ventricular dyssynchrony and subsequent pacing-induced cardiomyopathy. We hypothesized that left bundle branch area pacing may prevent the development of pacing-induced cardiomyopathy in patients with permanent atrial fibrillation requiring permanent ventricular… Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Pacing-Induced Cardiomyopathy
- What is being tested?
- Single-chamber pacemaker implantation with left bundle branch area pacing
- Type of treatment
- Medical device
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- 1 May 2020to 30 Oct 2022
- How long will I take part?
- 6 Months
- Phase
- Observational
- 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 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients indicated with pacemaker implantation and atrioventricular junction ablation for symptomatic chronic atrial arrhythmia.
Who may be able to join
- Permanent atrial arrhythmia
- Symptoms related to an insufficient rate control under optimal medical therapy
Who cannot join
- Indication of prophylactic defibrillator
- Already implanted with a cardiac device
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
CHRU de Tours
Tours, Please Select..., 37000
Nicolas CLEMENTY, MD, PhD, 0033247474747, nclementy@yahoo.fr
About this study
Permanent ventricular pacing may be complicated with ventricular dyssynchrony and subsequent pacing-induced cardiomyopathy. We hypothesized that left bundle branch area pacing may prevent the development of pacing-induced cardiomyopathy in patients with permanent atrial fibrillation requiring permanent ventricular pacing.
Patients with permanent atrial arrhythmia with an indication of cardiac pacing and atrioventricular junction ablation will be prospectively enrolled.
They will undergo the implantation of a single-chamber pacemaker with left bundle branch area pacing, and then atrioventricular junction ablation.
They will be prospectively followed during 6 months.
Read the detailed description
Patients with permanent atrial arrhythmia with an indication of cardiac pacing and atrioventricular junction ablation will be prospectively enrolled.
They will undergo the implantation of a single-chamber pacemaker with left bundle branch area pacing confirmed according to electrocardiographic parameters. Atrioventricular node ablation will be performed the following day through a femoral venous approach.
Perioperative data and potential complications will be collected. Patients will be prospectively followed during 6 months. They will have clinical examination, 12-lead ECG, and an echocardiography.
- Conditions
- Pacing-Induced Cardiomyopathy
- Being tested
- Single-chamber pacemaker implantation with left bundle branch area pacing
- Keywords
- left bundle branch area pacing; atrial fibrillation; atrioventricular ablation; pacing-induced cardiomyopathy
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Single-chamber pacemaker implantation with left bundle branch area pacingDevice
Also called Atrioventricular junction ablation
A prepectoral single-chamber pacemaker is implanted with a 3830 (Medtronic) IS-1 pacing lead screwed via the right ventricle in the deep interventricular septum in order to capture the left Purkinje system on the left ventricular endocardial side.
| Study group | Role | What they receive |
|---|---|---|
| LBBAP | Patients with permanent atrial arrhythmia with an indication of cardiac pacing and atrioventricular junction ablation will undergo the implantation of a single-chamber pacemaker with left bundle branch area pacing, and then atrioventricular junction ablation. Receives: Device: Single-chamber pacemaker implantation with left bundle branch area pacing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Heart failure hospitalization
Hospitalization for decompensated heart failure
Measured: 6 months
Secondary outcomes (4)
Mortality
Death from any cause
Measured: 6 months
Electrical remodeling
QRS width
Measured: 6 months
Complications
Perioperative complications
Measured: 30 days
Volumetric response
Left ventricular ejection fraction, left ventricular volumes
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2021
- Study start1 May 2020
- Primary completion30 May 2022 (estimated)
- Study completion30 Oct 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pacing-Induced CardiomyopathyStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Nicolas Clementy, MD, PhD
- Sponsor type
- University, hospital or other
- Collaborators
- Dr Arnaud BISSON
- Responsible party
- Sponsor-investigator, Nicolas Clementy, MD, PhD, University Hospital, Tours
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05162716
- Sponsor's protocol ID
- CROSS-LEFT AF
- Acronym
- CROSS-LEFT-AF
- Status last verified
- Dec 2021
- First submitted
- 8 Dec 2021
- Last updated
- 17 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiac ResynchrOniSation Via Stimulation of the LEFT Bundle in AF Patients.
- ClinicalTrials.gov ID
- NCT05162716
- Acronym / sponsor ID
- CROSS-LEFT-AF / CROSS-LEFT AF
- Conditions
- Pacing-Induced Cardiomyopathy
- Keywords
- left bundle branch area pacing; atrial fibrillation; atrioventricular ablation; pacing-induced cardiomyopathy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Nicolas Clementy, MD, PhDUniversity, hospital or other
- Collaborators
- Dr Arnaud BISSON
- Study start
- 1 May 2020 (actual)
- Primary completion
- 30 May 2022 (estimated)
- Study completion
- 30 Oct 2022 (estimated)
- First posted
- 17 Dec 2021 (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.
Permanent ventricular pacing may be complicated with ventricular dyssynchrony and subsequent pacing-induced cardiomyopathy. We hypothesized that left bundle branch area pacing may prevent the development of pacing-induced cardiomyopathy in patients with permanent atrial fibrillation requiring permanent ventricular pacing.
Patients with permanent atrial arrhythmia with an indication of cardiac pacing and atrioventricular junction ablation will be prospectively enrolled.
They will undergo the implantation of a single-chamber pacemaker with left bundle branch area pacing, and then atrioventricular junction ablation.
They will be prospectively followed during 6 months.
Detailed description
Patients with permanent atrial arrhythmia with an indication of cardiac pacing and atrioventricular junction ablation will be prospectively enrolled.
They will undergo the implantation of a single-chamber pacemaker with left bundle branch area pacing confirmed according to electrocardiographic parameters. Atrioventricular node ablation will be performed the following day through a femoral venous approach.
Perioperative data and potential complications will be collected. Patients will be prospectively followed during 6 months. They will have clinical examination, 12-lead ECG, and an echocardiography.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| LBBAP | – | Device: Single-chamber pacemaker implantation with left bundle branch area pacingPatients with permanent atrial arrhythmia with an indication of cardiac pacing and atrioventricular junction ablation will undergo the implantation of a single-chamber pacemaker with left bundle branch area pacing, and then atrioventricular junction ablation. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients indicated with pacemaker implantation and atrioventricular junction ablation for symptomatic chronic atrial arrhythmia.
Key inclusion criteria (2 listed)
- Permanent atrial arrhythmia
- Symptoms related to an insufficient rate control under optimal medical therapy
Key exclusion criteria (2 listed)
- Indication of prophylactic defibrillator
- Already implanted with a cardiac device
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 |
|---|---|---|
| Single-chamber pacemaker implantation with left bundle branch area pacingAlso: Atrioventricular junction ablationA prepectoral single-chamber pacemaker is implanted with a 3830 (Medtronic) IS-1 pacing lead screwed via the right ventricle in the deep interventricular septum in order to capture the left Purkinje system on the left ventricular endocardial side. | Device | LBBAP |
Primary outcome
Heart failure hospitalization
Time frame: 6 months
Hospitalization for decompensated heart failure
4 secondary outcomes
Mortality
Time frame: 6 months
Electrical remodeling
Time frame: 6 months
Complications
Time frame: 30 days
Volumetric response
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2021.
- Individual participant dataSharing planned: Undecided
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Patient Selection and Long-Term Outcomes of Pace & Ablate Strategy in Atrial Fibrillation
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Pacing Advancements With Cost and Experience VALuation for Unified Patient-Led Clinical Evidence - the PACEVALUE Study
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Not yet recruiting
Procedural Endpoint in Left Bundle Branch Area Pacing: Conduction System Capture Versus LV Septal Capture
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Comparing the Effects of Newer Pacemakers and Their Effects on the Heart and Valve Function in the Short-term.
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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. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pacing-Induced Cardiomyopathy, run by Nicolas Clementy, MD, PhD at 1 site in France.
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 2 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 17 Dec 2021. 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nicolas CLEMENTY (+33618072141, nclementy@yahoo.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Heart failure hospitalization (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Dec 2021.