Persistent Atrial FibrillationLAMPPNCT03242694
Left Atrial Function Analysis for Patients With Persistent Atrial Fibrillation Undergoing Pulmonary Vein Isolation
An observational study of Persistent Atrial Fibrillation and Catheter Ablation, run by Semmelweis University Heart and Vascular Center at 1 site in Hungary.
Trial summary
This prospective observational study is designed to describe the factors determining the success of pulmonary vein isolation (PVI) for patients with persistent atrial fibrillation (AF). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Persistent Atrial Fibrillation, Catheter Ablation
- What is being tested?
- LA pressure, voltage map, strain, scar-map, blood sampling and pulmonary vein isolation
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- 1 siteHungary
- Study dates
- 1 Aug 2017to 31 Dec 2019
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with persistent atrial fibrillation referred for pulmonary vein isolation at Heart and Vascular Center of Semmelweis University, Budapest, Hungary.
Who may be able to join
- documented, symptomatic persistent atrial fibrillation (AF)
- catheter ablation is indicated
- aged 18-75 years
- signed Patient Informed Consent Form
- able and willing to comply with all pre-, post-, and follow-up testing and requirements
Who cannot join
- secondary AF
- paroxysmal, long-standing persistent or permanent AF
- ejection fraction < 30%
- GFR <30 ml/min/1.73m2
- unstable angina pectoris or myocardial infarction within the past 2 months
- severe heart failure (NYHA IV)
Show all 20Show fewer
- severe COPD (GOLD III-IV)
- previous left atrial catheter ablation
- previous transthoracic cardiac surgery
- implanted cardiac device (pacemaker, ICD, CRT, VAD)
- awaiting cardiac transplantation or other cardiac surgery within the next 12 months
- any contraindication for pulmonary vein isolation, MRI or anticoagulation
- coagulopathy
- active malignancy, left atrial myxoma
- autoimmune disorder, chronic inflammatory disease
- acute illness, active systemic infection, sepsis
- women who are pregnant, breast feeding, or planning to become pregnant in the next 12 months
- aged under 18 years or above 75 years
- enrollment in other studies, which exclude participation in other studies
- patient not willing or not able to sign the informed consent form
Trial locations and contacts
1 site in 1 country.
Hungary1 site, 1 recruiting
- Recruiting
Heart and Vascular Center of Semmelweis University
Budapest, 1122
Peter Perge, MD, 0036208259612, perge.peter@med.semmelweis-univ.hu
About this study
Official title: Left Atrial Function Analysis With Multimodal Techniques for Patients With Persistent Atrial Fibrillation Undergoing Pulmonary Vein Isolation
This prospective observational study is designed to describe the factors determining the success of pulmonary vein isolation (PVI) for patients with persistent atrial fibrillation (AF). These factors - described as left atrial (LA) function - are simultaneously studied by multi-modal techniques in patients undergoing radiofrequency ablation. The simultaneous measurements are conducted before the PVI in AF and after the sinus rhythm converted due to PVI. These measurements include invasive LA pressure monitoring, LA voltage map creation, LA strain evaluation by transthoracal echocardiography, LA scar-mapping by cardiac MRI, defining biomarkers from blood samples. During the one year follow-up period rhythm monitoring is conducted by regular Holter-monitoring. Our aim is to define the predictive values of the above mentioned factors and to create a new score system for predicting PVI success in persistent AF population.
- Conditions
- Persistent Atrial Fibrillation, Catheter Ablation
- Being tested
- LA pressure, voltage map, strain, scar-map, blood sampling, pulmonary vein isolation
- Keywords
- persistent atrial fibrillation, pulmonary vein isolation, catheter ablation, left atrial function, left atrial pressure, voltage map, strain, scar, success, biomarker
- Medical subject headings
- Atrial Fibrillation, Sprains and Strains, Cicatrix
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LA pressure, voltage map, strain, scar-map, blood samplingDiagnostic test
invasive LA pressure monitoring, LA voltage map creation, LA strain evaluation by transthoracal echocardiography, LA scar-mapping by cardiac MRI, defining biomarkers from blood samples during atrial fibrillation and after pulmonary vein isolation in sinus rhythm
pulmonary vein isolationProcedure or surgery
pulmonary vein isolation without creating additional ablation lesions
| Study group | Role | What they receive |
|---|---|---|
| persistent atrial fibrillation | invasive LA pressure monitoring, LA voltage map creation, LA strain evaluation by transthoracal echocardiography, LA scar-mapping by cardiac MRI, defining biomarkers from blood samples during atrial fibrillation and after pulmonary vein isolation in sinus rhythm Receives: Diagnostic Test: LA pressure, voltage map, strain, scar-map, blood sampling; Procedure: pulmonary vein isolation |
What is being measured
The primary outcome is the main question the study is designed to answer.
one-year success of pulmonary vein isolation
one-year success without recurrent atrial fibrillation or atrial tachycardia without antiarrhythmic drugs after the three-month blanking period of pulmonary vein isolation
Measured: 3-12 months after the first pulmonary vein isolation
Secondary outcomes (6)
acute unsuccessful pulmonary vein isolation
operator is unable to disconnect pulmonary veins from the left atrium
Measured: within 5 minutes after the last application is performed at the ablation procedure
usage of antiarrhythmic drugs after the three-month blanking period
antiarrhythmic drugs: sotalol, amiodarone, propafenon
Measured: 3-12 months after the first pulmonary vein isolation
reablation
repeated left atrial ablation is performed due to atrial fibrillation or left atrial tachycardia recurrence
Measured: 3-12 months after the first pulmonary vein isolation
major complications of pulmonary vein isolation
major complications: requiring surgical intervention or causing prolonged hospitalisation
Measured: through 1 year follow-up after the first pulmonary vein isolation
MACE
major adverse cardiac events
Measured: through 1 year follow-up after the first pulmonary vein isolation
death
Measured: through 1 year follow-up after the first pulmonary vein isolation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2017
- Study start1 Aug 2017
- Primary completion31 Dec 2019 (estimated)
- Study completion31 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Persistent Atrial FibrillationStudies 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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Semmelweis University Heart and Vascular Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Laszlo Geller, MD PhD, Principal investigator, Heart and Vascular Center of Semmelweis UniversityBela Merkely, MD PhD DSc, Study director, Heart and Vascular Center of Semmelweis University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03242694
- Sponsor's protocol ID
- LAMPP 1.0
- Acronym
- LAMPP
- Status last verified
- Aug 2017
- First submitted
- 31 Jul 2017
- Last updated
- 8 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Left Atrial Function Analysis With Multimodal Techniques for Patients With Persistent Atrial Fibrillation Undergoing Pulmonary Vein Isolation
- ClinicalTrials.gov ID
- NCT03242694
- Acronym / sponsor ID
- LAMPP / LAMPP 1.0
- Conditions
- Persistent Atrial Fibrillation, Catheter Ablation
- Keywords
- persistent atrial fibrillation, pulmonary vein isolation, catheter ablation, left atrial function, left atrial pressure, voltage map, strain, scar
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Semmelweis University Heart and Vascular CenterUniversity, hospital or other
- Study start
- 1 Aug 2017 (actual)
- Primary completion
- 31 Dec 2019 (estimated)
- Study completion
- 31 Dec 2019 (estimated)
- First posted
- 8 Aug 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.
This prospective observational study is designed to describe the factors determining the success of pulmonary vein isolation (PVI) for patients with persistent atrial fibrillation (AF). These factors - described as left atrial (LA) function - are simultaneously studied by multi-modal techniques in patients undergoing radiofrequency ablation. The simultaneous measurements are conducted before the PVI in AF and after the sinus rhythm converted due to PVI. These measurements include invasive LA pressure monitoring, LA voltage map creation, LA strain evaluation by transthoracal echocardiography, LA scar-mapping by cardiac MRI, defining biomarkers from blood samples. During the one year follow-up period rhythm monitoring is conducted by regular Holter-monitoring. Our aim is to define the predictive values of the above mentioned factors and to create a new score system for predicting PVI success in persistent AF population.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| persistent atrial fibrillation | – | Diagnostic Test: LA pressure, voltage map, strain, scar-map, blood sampling, Procedure: pulmonary vein isolationinvasive LA pressure monitoring, LA voltage map creation, LA strain evaluation by transthoracal echocardiography, LA scar-mapping by cardiac MRI, defining biomarkers from blood samples during atrial fibrillation and after pulmonary vein isolation in sinus rhythm |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with persistent atrial fibrillation referred for pulmonary vein isolation at Heart and Vascular Center of Semmelweis University, Budapest, Hungary.
Key inclusion criteria (5 listed)
- documented, symptomatic persistent atrial fibrillation (AF)
- catheter ablation is indicated
- aged 18-75 years
- signed Patient Informed Consent Form
- able and willing to comply with all pre-, post-, and follow-up testing and requirements
Key exclusion criteria (20 listed)
- secondary AF
- paroxysmal, long-standing persistent or permanent AF
- ejection fraction < 30%
- GFR <30 ml/min/1.73m2
- unstable angina pectoris or myocardial infarction within the past 2 months
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 |
|---|---|---|
| LA pressure, voltage map, strain, scar-map, blood samplinginvasive LA pressure monitoring, LA voltage map creation, LA strain evaluation by transthoracal echocardiography, LA scar-mapping by cardiac MRI, defining biomarkers from blood samples during atrial fibrillation and after pulmonary vein isolation in sinus rhythm | Diagnostic test | persistent atrial fibrillation |
| pulmonary vein isolationpulmonary vein isolation without creating additional ablation lesions | Procedure or surgery | persistent atrial fibrillation |
Primary outcome
one-year success of pulmonary vein isolation
Time frame: 3-12 months after the first pulmonary vein isolation
one-year success without recurrent atrial fibrillation or atrial tachycardia without antiarrhythmic drugs after the three-month blanking period of pulmonary vein isolation
6 secondary outcomes
acute unsuccessful pulmonary vein isolation
Time frame: within 5 minutes after the last application is performed at the ablation procedure
usage of antiarrhythmic drugs after the three-month blanking period
Time frame: 3-12 months after the first pulmonary vein isolation
reablation
Time frame: 3-12 months after the first pulmonary vein isolation
major complications of pulmonary vein isolation
Time frame: through 1 year follow-up after the first pulmonary vein isolation
MACE
Time frame: through 1 year follow-up after the first pulmonary vein isolation
death
Time frame: through 1 year follow-up after the first pulmonary vein isolation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2017.
- 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. This study is not recruiting at the moment.
Laszlo Geller, MD PhD principal investigator
Heart and Vascular Center of Semmelweis University
Bela Merkely, MD PhD DSc study director
Heart and Vascular Center of Semmelweis University
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 Persistent Atrial Fibrillation and Catheter Ablation, run by Semmelweis University Heart and Vascular Center at 1 site in Hungary.
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 20 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 8 Aug 2017. 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 Hungary. 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 Szilvia Herczeg, MD (0036206663198, herczeg.szilvia@med.semmelweis-univ.hu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
one-year success of pulmonary vein isolation (time frame: 3-12 months after the first pulmonary vein isolation). 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 8 Aug 2017.