Atrial FibrillationNCT02129842
Is Endothelial Function a Predictor of Successful Ablation Therapy Provided to Patients With Atrial Fibrillation?
An observational study of Atrial Fibrillation, run by Itamar-Medical, Israel at 6 sites in 4 countries.
Trial summary
The purpose of this study is to assess whether normal endothelial function in patients with Atrial Fibrillation undergoing ablation procedure increases the chances of a favorable clinical outcome and maintaining sinus rhythm following ablation Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation
- How many people
- 150 participants
- Where
- 6 sitesin 4 countries
- Study dates
- May 2014to Nov 2016
- 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: AFib patients eligible for ablation treatment
Who may be able to join
- All patients with AF considered eligible for ablation treatment may be included in this study (following unsuccessful attempts with AAD).
- Patients on optimal anticoagulation therapy
- The minimum AF documentation required as defined by the Heart Rhythm Society
Who cannot join
- Patients age below 18 years
- Cases with extremely abnormal anatomy (i.e., inverted heart)
- Moderate or severe mitral valve disease or mitral prosthetic valve
- Ejection fraction less than 30%
- Left atrial anteroposterior diameter more than 50 mm evaluated by echo or CT data (up to 6 months old)..
- Previous atrial fibrillation ablation occurred less than 6 months prior
Show all 15Show fewer
- Left atrium thrombus
- Acute infective disease or sepsis in the last 3 months
- Acute myocardial infarction in last 3 months
- Reduced expectancy of life (less than 12 months)
- Patient participating in another clinical study that investigates a drug or device unless prior approval is given by the sponsor
- Psychologically unstable patient or denies to give informed consent
- Deformities of the digits of the upper extremities, which preclude adequate signal acquisition
- Patients under the effect of short-acting Nitroglycerin (3 hours washout period)
- Patient suffering from a medical condition prohibiting blood flow occlusion in both arms
Trial locations and contacts
6 sites in 4 countries.
6 sites in 4 countries
United States3 sites
Texas Cardiac Arrhythmia Research Foundation
Austin, Texas, 78075
New York University School of Medicine
New York, New York, 10016
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
United Kingdom1 site
Royal Brompton & Harefield NHS Foundation Trust
London
About this study
Official title: A Prospective, Non-randomized, Double Blind Multicenter Study to Assess Endothelial Function Using Endo-PAT2000 and Its Correlation to Clinical Outcome Following Ablation in Patients With Atrial Fibrillation
The purpose of this study is to assess whether normal endothelial function in patients with Atrial Fibrillation undergoing ablation procedure increases the chances of a favorable clinical outcome and maintaining sinus rhythm following ablation
Read the detailed description
In the recent years, increasing evidence is linking inflammation to AFib. In addition, it has been shown that ablation improves endothelial function, suggesting that AFib might be associated with the etiology of endothelial dysfunction.
The objective of this study is to assess endothelial function using Endo-PAT2000 and its correlation to clinical outcome following ablation of patients with Atrial Fibrillation (AFib).
- Conditions
- Atrial Fibrillation
- Keywords
- AFib, AF, ablation, EndoPAT, Endothelial dysfunction, PAT
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Atrial Fibrillation | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Freedom from AF/AFL/AT off antiarrhythmic drugs therapy
Measured: 12 months
Secondary outcomes (2)
Acute procedural success: Pulmonary veins isolation
Measured: 12 months
75% reduction in the number/duration of AFib episodes
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2014 (estimated)
- Study startMay 2014
- Primary completionNov 2016
- Study completionNov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Itamar-Medical, Israel
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02129842
- Sponsor's protocol ID
- Endo-AFib-001
- Status last verified
- Dec 2014
- First submitted
- 30 Apr 2014
- Last updated
- 9 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Calkins H, Kuck KH, Cappato R, Brugada J, Camm AJ, Chen SA, Crijns HJ, Damiano RJ Jr, Davies DW, DiMarco J, Edgerton J, Ellenbogen K, Ezekowitz MD, Haines DE, Haissaguerre M, Hindricks G, Iesaka Y, Jackman W, Jalife J, Jais P, Kalman J, Keane D, Kim YH, Kirchhof P, Klein G, Kottkamp H, Kumagai K, Lindsay BD, Mansour M, Marchlinski FE, McCarthy PM, Mont JL, Morady F, Nademanee K, Nakagawa H, Natale A, Nattel S, Packer DL, Pappone C, Prystowsky E, Raviele A, Reddy V, Ruskin JN, Shemin RJ, Tsao HM, Wilber D. 2012 HRS/EHRA/ECAS Expert Consensus Statement on Catheter and Surgical Ablation of Atrial Fibrillation: recommendations for patient selection, procedural techniques, patient management and follow-up, definitions, endpoints, and research trial design. Europace. 2012 Apr;14(4):528-606. doi: 10.1093/europace/eus027. Epub 2012 Mar 1. No abstract available.
PubMed 22389422Narayan SM, Krummen DE, Clopton P, Shivkumar K, Miller JM. Direct or coincidental elimination of stable rotors or focal sources may explain successful atrial fibrillation ablation: on-treatment analysis of the CONFIRM trial (Conventional ablation for AF with or without focal impulse and rotor modulation). J Am Coll Cardiol. 2013 Jul 9;62(2):138-147. doi: 10.1016/j.jacc.2013.03.021. Epub 2013 Apr 3.
PubMed 23563126Pokushalov E, Romanov A, Artyomenko S, Turov A, Shugayev P, Shirokova N, Katritsis DG. Ganglionated plexi ablation for longstanding persistent atrial fibrillation. Europace. 2010 Mar;12(3):342-6. doi: 10.1093/europace/euq014.
PubMed 20173210Boos CJ, Anderson RA, Lip GY. Is atrial fibrillation an inflammatory disorder? Eur Heart J. 2006 Jan;27(2):136-49. doi: 10.1093/eurheartj/ehi645. Epub 2005 Nov 8.
PubMed 16278230Yoshino S, Yoshikawa A, Hamasaki S, Ishida S, Oketani N, Saihara K, Okui H, Kuwahata S, Fujita S, Ichiki H, Ueya N, Iriki Y, Maenosono R, Miyata M, Tei C. Atrial fibrillation-induced endothelial dysfunction improves after restoration of sinus rhythm. Int J Cardiol. 2013 Sep 30;168(2):1280-5. doi: 10.1016/j.ijcard.2012.12.006. Epub 2012 Dec 24.
PubMed 23269316
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Non-randomized, Double Blind Multicenter Study to Assess Endothelial Function Using Endo-PAT2000 and Its Correlation to Clinical Outcome Following Ablation in Patients With Atrial Fibrillation
- ClinicalTrials.gov ID
- NCT02129842
- Acronym / sponsor ID
- Endo-AFib-001
- Conditions
- Atrial Fibrillation
- Keywords
- AFib, AF, ablation, EndoPAT, Endothelial dysfunction, PAT
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Itamar-Medical, IsraelIndustry (pharma, biotech, devices)
- Study start
- May 2014
- Primary completion
- Nov 2016 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 2 May 2014 (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 whether normal endothelial function in patients with Atrial Fibrillation undergoing ablation procedure increases the chances of a favorable clinical outcome and maintaining sinus rhythm following ablation
Detailed description
In the recent years, increasing evidence is linking inflammation to AFib. In addition, it has been shown that ablation improves endothelial function, suggesting that AFib might be associated with the etiology of endothelial dysfunction.
The objective of this study is to assess endothelial function using Endo-PAT2000 and its correlation to clinical outcome following ablation of patients with Atrial Fibrillation (AFib).
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Atrial Fibrillation | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- AFib patients eligible for ablation treatment
Key inclusion criteria (3 listed)
- All patients with AF considered eligible for ablation treatment may be included in this study (following unsuccessful attempts with AAD).
- Patients on optimal anticoagulation therapy
- The minimum AF documentation required as defined by the Heart Rhythm Society
Key exclusion criteria (15 listed)
- Patients age below 18 years
- Cases with extremely abnormal anatomy (i.e., inverted heart)
- Moderate or severe mitral valve disease or mitral prosthetic valve
- Ejection fraction less than 30%
- Left atrial anteroposterior diameter more than 50 mm evaluated by echo or CT data (up to 6 months old)..
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
Freedom from AF/AFL/AT off antiarrhythmic drugs therapy
Time frame: 12 months
2 secondary outcomes
Acute procedural success: Pulmonary veins isolation
Time frame: 12 months
75% reduction in the number/duration of AFib episodes
Time frame: 12 months
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 9 Mar 2017.
- Background: PubMed 22389422Calkins H, Kuck KH, Cappato R, Brugada J, Camm AJ, Chen SA, Crijns HJ, Damiano RJ Jr, Davies DW, DiMarco J, Edgerton J, Ellenbogen K, Ezekowitz MD, Haines DE, Haissaguerre M, Hindricks G, Iesaka Y, Jackman W, Jalife J, Jais P, Kalman J, Keane D, Kim YH, Kirchhof P, Klein G, Kottkamp H, Kumagai K, Lindsay BD, Mansour M, Marchlinski FE, McCarthy PM, Mont JL, Morady F, Nademanee K, Nakagawa H, Natale A, Nattel S, Packer DL, Pappone C, Prystowsky E, Raviele A, Reddy V, Ruskin JN, Shemin RJ, Tsao HM, Wilber D. 2012 HRS/EHRA/ECAS Expert Consensus Statement on Catheter and Surgical Ablation of Atrial Fibrillation: recommendations for patient selection, procedural techniques, patient management and follow-up, definitions, endpoints, and research trial design. Europace. 2012 Apr;14(4):528-606. doi: 10.1093/europace/eus027. Epub 2012 Mar 1. No abstract available.
- Background: PubMed 23563126Narayan SM, Krummen DE, Clopton P, Shivkumar K, Miller JM. Direct or coincidental elimination of stable rotors or focal sources may explain successful atrial fibrillation ablation: on-treatment analysis of the CONFIRM trial (Conventional ablation for AF with or without focal impulse and rotor modulation). J Am Coll Cardiol. 2013 Jul 9;62(2):138-147. doi: 10.1016/j.jacc.2013.03.021. Epub 2013 Apr 3.
- Background: PubMed 20173210Pokushalov E, Romanov A, Artyomenko S, Turov A, Shugayev P, Shirokova N, Katritsis DG. Ganglionated plexi ablation for longstanding persistent atrial fibrillation. Europace. 2010 Mar;12(3):342-6. doi: 10.1093/europace/euq014.
- Background: PubMed 16278230Boos CJ, Anderson RA, Lip GY. Is atrial fibrillation an inflammatory disorder? Eur Heart J. 2006 Jan;27(2):136-49. doi: 10.1093/eurheartj/ehi645. Epub 2005 Nov 8.
- Background: PubMed 23269316Yoshino S, Yoshikawa A, Hamasaki S, Ishida S, Oketani N, Saihara K, Okui H, Kuwahata S, Fujita S, Ichiki H, Ueya N, Iriki Y, Maenosono R, Miyata M, Tei C. Atrial fibrillation-induced endothelial dysfunction improves after restoration of sinus rhythm. Int J Cardiol. 2013 Sep 30;168(2):1280-5. doi: 10.1016/j.ijcard.2012.12.006. Epub 2012 Dec 24.
Related trials for Atrial Fibrillation
Active, not recruiting
VOLT CE Mark Study
Atrial Arrhythmia, Atrial Fibrillation
RecruitingObservational study
AI-Based Cardiac Analysis Using 12-Lead and 1-Lead ECG
Heart Failure, Atrial Fibrillation (AF)
RecruitingObservational study
Observational Study of Cardiac Arrhythmias During Treatment With BTK Inhibitors or Venetoclax
Chronic Lymphocytic Leukemia (CLL), Waldenstr(SqrRoot)(Delta)m s Macroglobulinemia
Not yet recruiting
CATCH AF - Atrial Fibrillation Detection in Cryptogenic Stroke
Atrial Fibrillation (AF)
Active, not recruiting
ARIADNE Clinical Trial
Persistent Atrial Fibrillation
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.
6 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atrial Fibrillation, run by Itamar-Medical, Israel at 6 sites in 4 countries.
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 3 inclusion and 15 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 9 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States, Germany, Israel, United Kingdom. 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.
What does the primary outcome measure?
Freedom from AF/AFL/AT off antiarrhythmic drugs therapy (time frame: 12 months). 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 NCT02129842, which also lists 5 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 9 Mar 2017.