Atrial FibrillationREDUCE-AFNCT06465706
Assessing the Safety and Efficacy of the LAmbre™ Plus Device
A study testing LAmbre investigational device in people with Atrial Fibrillation, run by Kansas City Heart Rhythm Research Foundation.
Trial summary
Randomized controlled trial assessing the safety and efficacy of the LAmbre Plus LAA Closure System to rescue the risk of thromboembolism in patients with non-valvular AF. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- LAmbre investigational device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,826 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2024to 31 Jan 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The patient is a male or non-pregnant female ≥18 years of age
- The patient has documented paroxysmal, persistent, or permanent non- valvular atrial fibrillation
- The patient has a CHADS2 score ≥ 2 or a CHA2DS2-VASc score of ≥ 3, and is recommended for oral anticoagulation therapy
- The patient is deemed by their physician to be suitable for short-term warfarin therapy, but there is an appropriate rationale for seeking a non-pharmacologic alternative to oral anticoagulation
- The patient is deemed suitable for LAA closure by a multidisciplinary heart team, including at least 1 investigator (e.g. cardiologists) and 1 clinician not involved as part of the procedure team using a shared decision making process, and this determination has been documented in the patient's medical record
- The patient is willing and able to comply with protocol-specified treatment and follow-up evaluations
- The patient (or his or her legally authorized representative) has been informed of the nature of the study, agrees to its provisions, and has been provided written informed consent approved by the appropriate Institutional Review Board (IRB) or Ethics Committee (EC)
Who cannot join
- Pregnant or nursing patients and those who plan pregnancy in the period up to 1 year following index procedure. Female patients of childbearing potential must have a negative pregnancy test done within 7 days prior to index procedure per site standard test.
- Patients with atrial fibrillation that is defined by a single occurrence, or that is transient or reversible (e.g., secondary to CABG, an interventional procedure, pneumonia, or hyperthyroidism)
- Patients who require long-term anticoagulation for a condition other than atrial fibrillation
- Patients with an indication for chronic P2Y12 platelet inhibition therapy
- Patients not suitable for short term warfarin (including due to bleeding diathesis or coagulopathy or absolute contraindication warfarin) or who will refuse transfusion
- Patients with rheumatic mitral valve disease, known severe aortic stenosis requiring surgical or percutaneous valve replacement, or existing mechanical valve prosthesis
Show all 25Show fewer
- Active infection with bacteremia
- Known hypersensitivity or contraindication to aspirin, clopidogrel, heparin/bivalirudin, any device material or component (nitinol, nickel, titanium, PET), and/or contrast sensitivity that cannot be adequately pre-medicated
- Anatomic conditions that would prevent performance of the LAA occlusion procedure (e.g., prior atrial septal defect [ASD] or patient foramen ovale [PFO] surgical repair or implanted closure device, or obliterated left atrial appendage)
- Recent (within 30 days pre-procedure) or planned (within 60 days post- procedure) cardiac or non-cardiac interventional or surgical procedure (e.g., cardioversion, ablation, percutaneous coronary intervention, cataract surgery, etc.)
- Recent (within 90 days pre-procedure) stroke, transient ischemic attack, or myocardial infarction
- Severe heart failure (New York Heart Association Class IV)
- Known asymptomatic carotid artery disease with>70% diameter stenosis OR symptomatic carotid disease (>50% diameter stenosis with ipsilateral stroke or TIA). Subjects with prior carotid endarterectomy or carotid stent placement may be enrolled, provided that known diameter stenosis is <50%.
- Past or pending heart or any other organ transplant, or on the waiting list for any organ transplant
- Known other medical illness or known history of substance abuse that may cause non-compliance with the protocol, confound data interpretation, or is associated with a life expectancy of less than 2 years
- Current participation in another investigational drug or device study Echocardiographic Exclusion Criteria
- Left atrial appendage anatomy cannot accommodate either the LAmbre Plus LAAO device or the Control device per manufacturer IFU (e.g., the anatomy and sizing must be for both device to be enrolled in the trial or maximum LAAO length < maximum ostium width by TEE)
- LVEF <30%
- Intracardiac thrombus or dense spontaneous echo contrast, as visualized by TEE within 2 days prior to implant
- Moderate or large circumferential pericardial effusion >10 mm or symptomatic pericardial effusion, signs or symptoms of acute or chronic pericarditis, or evidence of tamponade physiology. In the event of a treatable pericardial effusion, the subject may undergo implantation at a later time after it is adequately treated.
- Atrial septal defect that warrants closure.
- Presence of a high risk patent foramen ovale (PFO), defined as an atrial septal aneurysm (excursion >15 mm or length >15 mm) or large shunt (early, within 3 beats and/or substantial passage of bubbles)
- Moderate or severe mitral valve stenosis (mitral valve area <1.5 cm2)
- Complex atheroma with mobile plaque of the descending aorta and/or aortic arch (Grade 4 or higher)
- Evidence of a Cardiac Tumor
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Prospective, Multicenter, Randomized Controlled Trial Assessing the Safety and Efficacy of the LAmbre™ Plus Left Atrial Appendage Closure System to REDUCE the Risk of Thromboembolism in Patients With Non-Valvular Atrial Fibrillation
Randomized controlled trial assessing the safety and efficacy of the LAmbre Plus LAA Closure System to rescue the risk of thromboembolism in patients with non-valvular AF.
Read the detailed description
The goal of this clinical trial is to demonstrate the safety and efficacy of the LAmbre Plus device in patients with non-valvular atrial fibrillation in comparison with the commercially available transcatheter LAAO device(s). The main questions it aims to answer are:
Overall safety of the device that is assessed at the 12 month time period. Overall efficacy, after all subjects have reached the 18 month time period.
Participants will be randomized to either the LAmbre device or other FDA approved LAAO devices.
- Conditions
- Atrial Fibrillation
- Being tested
- LAmbre investigational device
- Keywords
- Left Atrial Appendage Occlusion, Stroke Risk
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LAmbre investigational deviceDevice
Randomized 1:1 to either experimental group or control group.
| Study group | Role | What they receive |
|---|---|---|
| LAmbre Device | Experimental | LAmbre Plus LAAO is a second-generation device intended for investigational use only in the United States. Receives: Device: LAmbre investigational device |
| FDA approved LAAO devices | Active comparator | The control devices for the study will be commercially available transcatheter LAAO devices. Currently, there are three FDA approved devices (WATCHMAN FLX and WATCHMAN FLX Pro from Boston Scientific and Amplatzer Amulet from Abbott Laboratories) all of which can be used in subjects assigned to the control group. Receives: Device: LAmbre investigational device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major procedure related complications - cardiac perforation
Cardiac perforation can be seen interprocedurally through ICE or TEE, post procedurally via TTE or TEE.
Measured: up to 7 days following implant procedure
Major procedure related complications - pericardial effusion with tamponade or requiring drainage
Common complications can be seen interprocedurally through ICE or TEE, post procedurally via TTE or TEE.
Measured: up to 7 days following implant procedure
Major procedure related complications - device embolization
Procedure complications can be seen interprocedurally through ICE or TEE, post procedurally via TTE or TEE.
Measured: up to 7 days following implant procedure
Major adverse event - Death
Death is observed by lack of oxygen, lack of pulse, succession of neurological activity.
Measured: up to 7 days following implant procedure
Major adverse event - all strokes
Stroke is identified by neurologic imaging and transient or permanent motor or sensory deficient.
Measured: up to 7 days following implant procedure
Major adverse event - systemic embolization
Systemic embolization assessed by onsite symptoms and confirmed by diagnostic imaging.
Measured: up to 7 days following implant procedure
Major adverse event - major bleeding
Visual bleeding or a drop in hemoglobin of 2 units and requiring transfusion.
Measured: up to 7 days following implant procedure
Secondary outcomes (7)
Major adverse event
composite of cardiovascular death, overs CNS injury and major bleeding
Measured: 45 days, 6 months, 12 months, 18 months and 2, 3, 4, and 5 years
mortality
cardiovascular or non-cardiovascular and reported cumulatively and individually
Measured: 45 days, 6 months, 12 months, 18 months and 2, 3, 4, and 5 years
myocardial infarction
Defined as ST or nonST ECG changes with positive cardiac bio markers.
Measured: 45 days, 6 months, 12 months, 18 months and 2, 3, 4, and 5 years
periprocedural stroke
Motor and sensory deficits observed and imaging confirmed.
Measured: 45 days, 6 months, 12 months, 18 months and 2, 3, 4, and 5 years
bleeding complications
Visual bleeding or a drop in hemoglobin
Measured: 45 days, 6 months, 12 months, 18 months and 2, 3, 4, and 5 years
major procedure-related complications
vascular or cardiac complications occurring due to the procedure.
Measured: 45 days, 6 months, 12 months, 18 months and 2, 3, 4, and 5 years
vascular complications
vascular complications are hematomas, aneurysms, and ischemic limb.
Measured: 45 days, 6 months, 12 months, 18 months and 2, 3, 4, and 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2024
- Study start1 Sep 2024 (estimated)
- Primary completion1 Oct 2029 (estimated)
- Study completion31 Jan 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (48)Papers the sponsor has linked to this study.
- Other trials for 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 1,826 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kansas City Heart Rhythm Research Foundation
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dhanunjaya Lakkireddy, MD, Principal investigator, KCCARF
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06465706
- Sponsor's protocol ID
- LA-US-01
- Acronym
- REDUCE-AF
- Status last verified
- Aug 2024
- First submitted
- 10 Jun 2024
- Last updated
- 23 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Lansky AJ, Messe SR, Brickman AM, Dwyer M, van der Worp HB, Lazar RM, Pietras CG, Abrams KJ, McFadden E, Petersen NH, Browndyke J, Prendergast B, Ng VG, Cutlip DE, Kapadia S, Krucoff MW, Linke A, Moy CS, Schofer J, van Es GA, Virmani R, Popma J, Parides MK, Kodali S, Bilello M, Zivadinov R, Akar J, Furie KL, Gress D, Voros S, Moses J, Greer D, Forrest JK, Holmes D, Kappetein AP, Mack M, Baumbach A. Proposed Standardized Neurological Endpoints for Cardiovascular Clinical Trials: An Academic Research Consortium Initiative. J Am Coll Cardiol. 2017 Feb 14;69(6):679-691. doi: 10.1016/j.jacc.2016.11.045.
PubMed 28183511Mandalenakis Z, Von Koch L, Eriksson H, Dellborg M, Caidahl K, Welin L, Rosengren A, Hansson PO. The risk of atrial fibrillation in the general male population: a lifetime follow-up of 50-year-old men. Europace. 2015 Jul;17(7):1018-22. doi: 10.1093/europace/euv036. Epub 2015 Apr 4.
PubMed 25842274Kalmykov NP, Mashchenko EN. New data on the migration of the family Elephantidae (Mammalia, Proboscidea) in Eurasia. Dokl Biol Sci. 2006 Jan-Feb;406:103-5. doi: 10.1134/s0012496606010303. No abstract available.
PubMed 16572828Go AS, Hylek EM, Phillips KA, Chang Y, Henault LE, Selby JV, Singer DE. Prevalence of diagnosed atrial fibrillation in adults: national implications for rhythm management and stroke prevention: the AnTicoagulation and Risk Factors in Atrial Fibrillation (ATRIA) Study. JAMA. 2001 May 9;285(18):2370-5. doi: 10.1001/jama.285.18.2370.
PubMed 11343485Dewland TA, Olgin JE, Vittinghoff E, Marcus GM. Incident atrial fibrillation among Asians, Hispanics, blacks, and whites. Circulation. 2013 Dec 3;128(23):2470-7. doi: 10.1161/CIRCULATIONAHA.113.002449. Epub 2013 Oct 8.
PubMed 24103419Lau DH, Nattel S, Kalman JM, Sanders P. Modifiable Risk Factors and Atrial Fibrillation. Circulation. 2017 Aug 8;136(6):583-596. doi: 10.1161/CIRCULATIONAHA.116.023163.
PubMed 28784826Wolf PA, Abbott RD, Kannel WB. Atrial fibrillation as an independent risk factor for stroke: the Framingham Study. Stroke. 1991 Aug;22(8):983-8. doi: 10.1161/01.str.22.8.983.
PubMed 1866765Stewart S, Hart CL, Hole DJ, McMurray JJ. A population-based study of the long-term risks associated with atrial fibrillation: 20-year follow-up of the Renfrew/Paisley study. Am J Med. 2002 Oct 1;113(5):359-64. doi: 10.1016/s0002-9343(02)01236-6.
PubMed 12401529Al-Saady NM, Obel OA, Camm AJ. Left atrial appendage: structure, function, and role in thromboembolism. Heart. 1999 Nov;82(5):547-54. doi: 10.1136/hrt.82.5.547.
PubMed 10525506Kong B, Liu Y, Huang H, Jiang H, Huang C. Left atrial appendage closure for thromboembolism prevention in patients with atrial fibrillation: advances and perspectives. J Thorac Dis. 2015 Feb;7(2):199-203. doi: 10.3978/j.issn.2072-1439.2015.01.20.
PubMed 25713737Hart RG, Pearce LA, Aguilar MI. Meta-analysis: antithrombotic therapy to prevent stroke in patients who have nonvalvular atrial fibrillation. Ann Intern Med. 2007 Jun 19;146(12):857-67. doi: 10.7326/0003-4819-146-12-200706190-00007.
PubMed 17577005January CT, Wann LS, Alpert JS, Calkins H, Cigarroa JE, Cleveland JC Jr, Conti JB, Ellinor PT, Ezekowitz MD, Field ME, Murray KT, Sacco RL, Stevenson WG, Tchou PJ, Tracy CM, Yancy CW; American College of Cardiology/American Heart Association Task Force on Practice Guidelines. 2014 AHA/ACC/HRS guideline for the management of patients with atrial fibrillation: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines and the Heart Rhythm Society. J Am Coll Cardiol. 2014 Dec 2;64(21):e1-76. doi: 10.1016/j.jacc.2014.03.022. Epub 2014 Mar 28. No abstract available.
PubMed 24685669Gage BF, van Walraven C, Pearce L, Hart RG, Koudstaal PJ, Boode BS, Petersen P. Selecting patients with atrial fibrillation for anticoagulation: stroke risk stratification in patients taking aspirin. Circulation. 2004 Oct 19;110(16):2287-92. doi: 10.1161/01.CIR.0000145172.55640.93. Epub 2004 Oct 11.
PubMed 15477396Lip GY, Nieuwlaat R, Pisters R, Lane DA, Crijns HJ. Refining clinical risk stratification for predicting stroke and thromboembolism in atrial fibrillation using a novel risk factor-based approach: the euro heart survey on atrial fibrillation. Chest. 2010 Feb;137(2):263-72. doi: 10.1378/chest.09-1584. Epub 2009 Sep 17.
PubMed 19762550Pisters R, Lane DA, Nieuwlaat R, de Vos CB, Crijns HJ, Lip GY. A novel user-friendly score (HAS-BLED) to assess 1-year risk of major bleeding in patients with atrial fibrillation: the Euro Heart Survey. Chest. 2010 Nov;138(5):1093-100. doi: 10.1378/chest.10-0134. Epub 2010 Mar 18.
PubMed 20299623
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multicenter, Randomized Controlled Trial Assessing the Safety and Efficacy of the LAmbre™ Plus Left Atrial Appendage Closure System to REDUCE the Risk of Thromboembolism in Patients With Non-Valvular Atrial Fibrillation
- ClinicalTrials.gov ID
- NCT06465706
- Acronym / sponsor ID
- REDUCE-AF / LA-US-01
- Conditions
- Atrial Fibrillation
- Keywords
- Left Atrial Appendage Occlusion, Stroke Risk
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,826 participants (estimated)
- Lead sponsor
- Kansas City Heart Rhythm Research FoundationUniversity, hospital or other
- Study start
- 1 Sep 2024 (estimated)
- Primary completion
- 1 Oct 2029 (estimated)
- Study completion
- 31 Jan 2030 (estimated)
- First posted
- 20 Jun 2024 (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.
Randomized controlled trial assessing the safety and efficacy of the LAmbre Plus LAA Closure System to rescue the risk of thromboembolism in patients with non-valvular AF.
Detailed description
The goal of this clinical trial is to demonstrate the safety and efficacy of the LAmbre Plus device in patients with non-valvular atrial fibrillation in comparison with the commercially available transcatheter LAAO device(s). The main questions it aims to answer are:
Overall safety of the device that is assessed at the 12 month time period. Overall efficacy, after all subjects have reached the 18 month time period.
Participants will be randomized to either the LAmbre device or other FDA approved LAAO devices.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LAmbre Device | Experimental | Device: LAmbre investigational deviceLAmbre Plus LAAO is a second-generation device intended for investigational use only in the United States. |
| FDA approved LAAO devices | Active comparator | Device: LAmbre investigational deviceThe control devices for the study will be commercially available transcatheter LAAO devices. Currently, there are three FDA approved devices (WATCHMAN FLX and WATCHMAN FLX Pro from Boston Scientific and Amplatzer Amulet from Abbott Laboratories) all of which can be used in subjects assigned to the control group. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- The patient is a male or non-pregnant female ≥18 years of age
- The patient has documented paroxysmal, persistent, or permanent non- valvular atrial fibrillation
- The patient has a CHADS2 score ≥ 2 or a CHA2DS2-VASc score of ≥ 3, and is recommended for oral anticoagulation therapy
- The patient is deemed by their physician to be suitable for short-term warfarin therapy, but there is an appropriate rationale for seeking a non-pharmacologic alternative to oral anticoagulation
- The patient is deemed suitable for LAA closure by a multidisciplinary heart team, including at least 1 investigator (e.g. cardiologists) and 1 clinician not involved as part of the procedure team using a shared decision making process, and this determination has been documented in the patient's medical record
Key exclusion criteria (25 listed)
- Pregnant or nursing patients and those who plan pregnancy in the period up to 1 year following index procedure. Female patients of childbearing potential must have a negative pregnancy test done within 7 days prior to index procedure per site standard test.
- Patients with atrial fibrillation that is defined by a single occurrence, or that is transient or reversible (e.g., secondary to CABG, an interventional procedure, pneumonia, or hyperthyroidism)
- Patients who require long-term anticoagulation for a condition other than atrial fibrillation
- Patients with an indication for chronic P2Y12 platelet inhibition therapy
- Patients not suitable for short term warfarin (including due to bleeding diathesis or coagulopathy or absolute contraindication warfarin) or who will refuse transfusion
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 |
|---|---|---|
| LAmbre investigational deviceRandomized 1:1 to either experimental group or control group. | Device | FDA approved LAAO devices, LAmbre Device |
Primary outcome
Major procedure related complications - cardiac perforation
Time frame: up to 7 days following implant procedure
Cardiac perforation can be seen interprocedurally through ICE or TEE, post procedurally via TTE or TEE.
Major procedure related complications - pericardial effusion with tamponade or requiring drainage
Time frame: up to 7 days following implant procedure
Common complications can be seen interprocedurally through ICE or TEE, post procedurally via TTE or TEE.
Major procedure related complications - device embolization
Time frame: up to 7 days following implant procedure
Procedure complications can be seen interprocedurally through ICE or TEE, post procedurally via TTE or TEE.
Major adverse event - Death
Time frame: up to 7 days following implant procedure
Death is observed by lack of oxygen, lack of pulse, succession of neurological activity.
Major adverse event - all strokes
Time frame: up to 7 days following implant procedure
Stroke is identified by neurologic imaging and transient or permanent motor or sensory deficient.
Major adverse event - systemic embolization
Time frame: up to 7 days following implant procedure
Systemic embolization assessed by onsite symptoms and confirmed by diagnostic imaging.
Major adverse event - major bleeding
Time frame: up to 7 days following implant procedure
Visual bleeding or a drop in hemoglobin of 2 units and requiring transfusion.
7 secondary outcomes
Major adverse event
Time frame: 45 days, 6 months, 12 months, 18 months and 2, 3, 4, and 5 years
mortality
Time frame: 45 days, 6 months, 12 months, 18 months and 2, 3, 4, and 5 years
myocardial infarction
Time frame: 45 days, 6 months, 12 months, 18 months and 2, 3, 4, and 5 years
periprocedural stroke
Time frame: 45 days, 6 months, 12 months, 18 months and 2, 3, 4, and 5 years
bleeding complications
Time frame: 45 days, 6 months, 12 months, 18 months and 2, 3, 4, and 5 years
major procedure-related complications
Time frame: 45 days, 6 months, 12 months, 18 months and 2, 3, 4, and 5 years
vascular complications
Time frame: 45 days, 6 months, 12 months, 18 months and 2, 3, 4, and 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2024.
- Background: PubMed 28183511Lansky AJ, Messe SR, Brickman AM, Dwyer M, van der Worp HB, Lazar RM, Pietras CG, Abrams KJ, McFadden E, Petersen NH, Browndyke J, Prendergast B, Ng VG, Cutlip DE, Kapadia S, Krucoff MW, Linke A, Moy CS, Schofer J, van Es GA, Virmani R, Popma J, Parides MK, Kodali S, Bilello M, Zivadinov R, Akar J, Furie KL, Gress D, Voros S, Moses J, Greer D, Forrest JK, Holmes D, Kappetein AP, Mack M, Baumbach A. Proposed Standardized Neurological Endpoints for Cardiovascular Clinical Trials: An Academic Research Consortium Initiative. J Am Coll Cardiol. 2017 Feb 14;69(6):679-691. doi: 10.1016/j.jacc.2016.11.045.
- Background: PubMed 25842274Mandalenakis Z, Von Koch L, Eriksson H, Dellborg M, Caidahl K, Welin L, Rosengren A, Hansson PO. The risk of atrial fibrillation in the general male population: a lifetime follow-up of 50-year-old men. Europace. 2015 Jul;17(7):1018-22. doi: 10.1093/europace/euv036. Epub 2015 Apr 4.
- Background: PubMed 16572828Kalmykov NP, Mashchenko EN. New data on the migration of the family Elephantidae (Mammalia, Proboscidea) in Eurasia. Dokl Biol Sci. 2006 Jan-Feb;406:103-5. doi: 10.1134/s0012496606010303. No abstract available.
- Background: PubMed 11343485Go AS, Hylek EM, Phillips KA, Chang Y, Henault LE, Selby JV, Singer DE. Prevalence of diagnosed atrial fibrillation in adults: national implications for rhythm management and stroke prevention: the AnTicoagulation and Risk Factors in Atrial Fibrillation (ATRIA) Study. JAMA. 2001 May 9;285(18):2370-5. doi: 10.1001/jama.285.18.2370.
- Background: PubMed 24103419Dewland TA, Olgin JE, Vittinghoff E, Marcus GM. Incident atrial fibrillation among Asians, Hispanics, blacks, and whites. Circulation. 2013 Dec 3;128(23):2470-7. doi: 10.1161/CIRCULATIONAHA.113.002449. Epub 2013 Oct 8.
- Background: PubMed 28784826Lau DH, Nattel S, Kalman JM, Sanders P. Modifiable Risk Factors and Atrial Fibrillation. Circulation. 2017 Aug 8;136(6):583-596. doi: 10.1161/CIRCULATIONAHA.116.023163.
- Background: PubMed 1866765Wolf PA, Abbott RD, Kannel WB. Atrial fibrillation as an independent risk factor for stroke: the Framingham Study. Stroke. 1991 Aug;22(8):983-8. doi: 10.1161/01.str.22.8.983.
- Background: PubMed 12401529Stewart S, Hart CL, Hole DJ, McMurray JJ. A population-based study of the long-term risks associated with atrial fibrillation: 20-year follow-up of the Renfrew/Paisley study. Am J Med. 2002 Oct 1;113(5):359-64. doi: 10.1016/s0002-9343(02)01236-6.
- Background: PubMed 10525506Al-Saady NM, Obel OA, Camm AJ. Left atrial appendage: structure, function, and role in thromboembolism. Heart. 1999 Nov;82(5):547-54. doi: 10.1136/hrt.82.5.547.
- Background: PubMed 25713737Kong B, Liu Y, Huang H, Jiang H, Huang C. Left atrial appendage closure for thromboembolism prevention in patients with atrial fibrillation: advances and perspectives. J Thorac Dis. 2015 Feb;7(2):199-203. doi: 10.3978/j.issn.2072-1439.2015.01.20.
- Background: PubMed 17577005Hart RG, Pearce LA, Aguilar MI. Meta-analysis: antithrombotic therapy to prevent stroke in patients who have nonvalvular atrial fibrillation. Ann Intern Med. 2007 Jun 19;146(12):857-67. doi: 10.7326/0003-4819-146-12-200706190-00007.
- Background: PubMed 24685669January CT, Wann LS, Alpert JS, Calkins H, Cigarroa JE, Cleveland JC Jr, Conti JB, Ellinor PT, Ezekowitz MD, Field ME, Murray KT, Sacco RL, Stevenson WG, Tchou PJ, Tracy CM, Yancy CW; American College of Cardiology/American Heart Association Task Force on Practice Guidelines. 2014 AHA/ACC/HRS guideline for the management of patients with atrial fibrillation: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines and the Heart Rhythm Society. J Am Coll Cardiol. 2014 Dec 2;64(21):e1-76. doi: 10.1016/j.jacc.2014.03.022. Epub 2014 Mar 28. No abstract available.
- 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.
Dhanunjaya Lakkireddy, MD principal investigator
KCCARF
Questions about this trial
What is this clinical trial studying?
A study testing LAmbre investigational device in people with Atrial Fibrillation, run by Kansas City Heart Rhythm Research Foundation.
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 7 inclusion and 25 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: opening soon, as of the sponsor's last update on 23 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Donita Atkins, RN, BSN (816-651-1969, datkins@kchrf.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Major procedure related complications - cardiac perforation (time frame: up to 7 days following implant procedure). The study lists 7 primary outcomes in all. 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 NCT06465706, which also lists 48 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 23 Aug 2024.