Heart Failure With Preserved Ejection FractionLEADNCT01618981
LEft Atrial Pacing in Diastolic Heart Failure
A study testing pace make active/inactive cross over in people with Heart Failure With Preserved Ejection Fraction and Atrial Dyssynchrony Syndrome, run by Centre Hospitalier Universitaire Dijon at 1 site in France.
Trial summary
The purpose of this study is to assess left atrial pacing therapy in patients with atrial dyssynchrony syndrome and heart failure with preserved ejection fraction. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Heart Failure With Preserved Ejection Fraction, Atrial Dyssynchrony Syndrome, Left Atrio-ventricular Asynchrony
- What is being tested?
- pace make active/inactive cross over
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- Not given
- Where
- 1 siteFrance
- Study dates
- Nov 2012to Apr 2016
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Age ≥ 65
- Sinus rhythm, PR < 220ms, QRS < 110ms
- Heart failure (NYHA class III-IV or II with hospitalization for heart failure)
- Ejection Fraction > 50%, restrictive mitral inflow, Lateral E/e' > 12 or septal E/e' > 15, Left atrial index volume > 34 ml/m²
- Atrial dyssynchrony syndrome: (TTE) inter-atrial time delay ≥ 70ms (difference between tricuspid and mitral P-A intervals or between mitral and tricupsid P-A' intervals with DTI)
- Left atrio-ventricular asynchrony: Time Difference between tricupsid and mitral A wave duration ≥ 35ms.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to assess left atrial pacing therapy in patients with atrial dyssynchrony syndrome and heart failure with preserved ejection fraction.
- Conditions
- Heart Failure With Preserved Ejection Fraction, Atrial Dyssynchrony Syndrome, Left Atrio-ventricular Asynchrony
- Being tested
- pace make active/inactive cross over
- Keywords
- Heart failure with preserved ejection fraction, atrial dyssynchrony syndrome, left atrio-ventricular asynchrony, pacemaker, left atrial pacing therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pace make active/inactive cross overProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| first active | Experimental | Not described Receives: Procedure: pace make active/inactive cross over |
| first inactive | Experimental | Not described Receives: Procedure: pace make active/inactive cross over |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2012 (estimated)
- Study startNov 2012
- Primary completionApr 2016
- Study completionApr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart Failure With Preserved Ejection FractionStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire DijonThe sponsor's other registered studies.
- 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
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Dijon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01618981
- Sponsor's protocol ID
- LAURENT PHRC N 2011
- Acronym
- LEAD
- Status last verified
- Dec 2018
- First submitted
- 7 Jun 2012
- Last updated
- 27 Dec 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- LEft Atrial Pacing in Diastolic Heart Failure
- ClinicalTrials.gov ID
- NCT01618981
- Acronym / sponsor ID
- LEAD / LAURENT PHRC N 2011
- Conditions
- Heart Failure With Preserved Ejection Fraction, Atrial Dyssynchrony Syndrome, Left Atrio-ventricular Asynchrony
- Keywords
- Heart failure with preserved ejection fraction, atrial dyssynchrony syndrome, left atrio-ventricular asynchrony, pacemaker, left atrial pacing therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Centre Hospitalier Universitaire DijonUniversity, hospital or other
- Study start
- Nov 2012 (actual)
- Primary completion
- Apr 2016 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 14 Jun 2012 (estimated)
- 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 purpose of this study is to assess left atrial pacing therapy in patients with atrial dyssynchrony syndrome and heart failure with preserved ejection fraction.
Study design
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| first active | Experimental | Procedure: pace make active/inactive cross over |
| first inactive | Experimental | Procedure: pace make active/inactive cross over |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (6 listed)
- Age ≥ 65
- Sinus rhythm, PR < 220ms, QRS < 110ms
- Heart failure (NYHA class III-IV or II with hospitalization for heart failure)
- Ejection Fraction > 50%, restrictive mitral inflow, Lateral E/e' > 12 or septal E/e' > 15, Left atrial index volume > 34 ml/m²
- Atrial dyssynchrony syndrome: (TTE) inter-atrial time delay ≥ 70ms (difference between tricuspid and mitral P-A intervals or between mitral and tricupsid P-A' intervals with DTI)
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| pace make active/inactive cross over | Procedure or surgery | first active, first inactive |
Primary outcome
Not reported in the source record.
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 27 Dec 2018.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing pace make active/inactive cross over in people with Heart Failure With Preserved Ejection Fraction and Atrial Dyssynchrony Syndrome, run by Centre Hospitalier Universitaire Dijon 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 6 inclusion and 0 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 27 Dec 2018. 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?
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.
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 27 Dec 2018.