Left Atrial VolumeiLAVNCT03141606
Left Atrial Volume as Predictor for Arrhythmic Events and CRT Response
An observational study of Left Atrial Volume, run by Ospedale Borgo Trento - Verona at 2 sites in Italy.
Trial summary
Left atrial volume role for CRT response and for arrhythmic events (VT/VF/AT/AF) onset Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Left Atrial Volume
- How many people
- 230 participants
- Where
- 2 sitesItaly
- Study dates
- Apr 2016to Feb 2020
- How long will I take part?
- 24 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients implanted with cardiac resynchronization therapy defirbillator devices and who meet the inclusion and exclusion criteria
Who may be able to join
- Patient with left ventricular ejection fraction ≤ 35%, II, III or IV NYHA Class, even if optimal medical therapy.
- Patients with standard indication to CRT according current guideline, sinus rhythm at implantation, LBBB and QRS duration >= 120 ms
- Patients who will undergo to a new CRT-defibrillator system implantation
- Patients who are able to understand and sign the informed consent
- Patients who are able to attend all required follow-up visits at the study centerfor 24 months
Who cannot join
- Age < 18 years
- Women who are pregnant or who are planning to become pregnant
- Patients with permanent Atrial Fibrillation or persistent Atrial Fibrillation in the 90 days preceding the implantation
- Patients with organic mitral valve disease
- Patients with prosthetic heart valves
- Patients who will undergo to upgrading from other devices (PM or ICD) to CRT, heart transplantation, patients with CRT devices
Trial locations and contacts
2 sites in 1 country.
Italy2 sites, 2 recruiting
- Recruiting
G. Panico Hospital
Tricase, Italy/Lecce
Pietro Palmisano, clinical-rhythmdetect@isis.it
- Recruiting
Borgo Trento Hospital
Verona
Giovanni Morani, 045 812 1111, giovanni.morani@ospedaleuniverona.it
About this study
Left atrial volume role for CRT response and for arrhythmic events (VT/VF/AT/AF) onset
- Conditions
- Left Atrial Volume
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiac remodelling
Evaluation of function and volume of left atrium (by means of echocardiographic measures) in terms of cardiac remodelling (at least 15% reduction in LVESV).
Measured: 6 months
CRT Predictor Index
Identification of left atrial index predicting CRT response
Measured: 6 months
Secondary outcomes (4)
Clinical benefit
Left atrial volume/function in terms of clinical benefit
- Clinical Composite Score evaluation
- QoL evaluation
Measured: 12 months
Cardiac remodelling
Left atrial volume/function in terms of cardiac remodelling
- LVEF
- LVESV/LVEF
Measured: 6 months
Atrial arrhythmias
Left atrial volume/function role in terms of:
- atrial arrhythmias onset
- Atrial arrhythmias burden
Measured: 24 months
Ventricular arrhythmias
Left atrial volume/function in terms of:
- ventricular arrhythmias onset
- ventricular arrhythmias burden
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2017
- Study startApr 2016
- Primary completionNov 2019 (estimated)
- Study completionFeb 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Left Atrial VolumeStudies 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
- 230 participants (estimated)
- Target duration
- 24 Months
Sponsor and investigators
- Lead sponsor
- Ospedale Borgo Trento - Verona
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Giovanni Morani, Ospedale Borgo Trento - Verona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03141606
- Sponsor's protocol ID
- 20140002277
- Acronym
- iLAV
- Status last verified
- Jul 2019
- First submitted
- 26 Apr 2017
- Last updated
- 1 Aug 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Left Atrial Volume as Predictor for Arrhythmic Events and CRT Response
- ClinicalTrials.gov ID
- NCT03141606
- Acronym / sponsor ID
- iLAV / 20140002277
- Conditions
- Left Atrial Volume
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 230 participants (estimated)
- Lead sponsor
- Ospedale Borgo Trento - VeronaUniversity, hospital or other
- Study start
- Apr 2016 (actual)
- Primary completion
- Nov 2019 (estimated)
- Study completion
- Feb 2020 (estimated)
- First posted
- 5 May 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.
Left atrial volume role for CRT response and for arrhythmic events (VT/VF/AT/AF) onset
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 24 Months
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients implanted with cardiac resynchronization therapy defirbillator devices and who meet the inclusion and exclusion criteria
Key inclusion criteria (5 listed)
- Patient with left ventricular ejection fraction ≤ 35%, II, III or IV NYHA Class, even if optimal medical therapy.
- Patients with standard indication to CRT according current guideline, sinus rhythm at implantation, LBBB and QRS duration >= 120 ms
- Patients who will undergo to a new CRT-defibrillator system implantation
- Patients who are able to understand and sign the informed consent
- Patients who are able to attend all required follow-up visits at the study centerfor 24 months
Key exclusion criteria (6 listed)
- Age < 18 years
- Women who are pregnant or who are planning to become pregnant
- Patients with permanent Atrial Fibrillation or persistent Atrial Fibrillation in the 90 days preceding the implantation
- Patients with organic mitral valve disease
- Patients with prosthetic heart valves
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Cardiac remodelling
Time frame: 6 months
Evaluation of function and volume of left atrium (by means of echocardiographic measures) in terms of cardiac remodelling (at least 15% reduction in LVESV).
CRT Predictor Index
Time frame: 6 months
Identification of left atrial index predicting CRT response
4 secondary outcomes
Clinical benefit
Time frame: 12 months
Cardiac remodelling
Time frame: 6 months
Atrial arrhythmias
Time frame: 24 months
Ventricular arrhythmias
Time frame: 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2019.
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Left Atrial Volume, run by Ospedale Borgo Trento - Verona at 2 sites in Italy.
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 6 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 1 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Italy. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cardiac remodelling (time frame: 6 months). The study lists 2 primary outcomes in all. 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 1 Aug 2019.