Paroxysmal Atrial Fibrillation Clinical Trial
Official title:
Atrial Electromechanical Function in Middle-aged Endurance Athletes With and Without Atrial Fibrillation
Verified date | November 2020 |
Source | University of Toronto |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
This study evaluates cardiac structure and function differences between healthy endurance trained athletes with atrial fibrillation and healthy age matched endurance trained athletes without atrial fibrillation. It is hypothesized that despite having similar structural adaptations of the heart (due to endurance training), athletes with atrial fibrillation display will impaired heart functional measures compared to endurance athletes without atrial fibrillation.
Status | Active, not recruiting |
Enrollment | 34 |
Est. completion date | August 2021 |
Est. primary completion date | August 2021 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Male |
Age group | 45 Years to 65 Years |
Eligibility | Inclusion Criteria: ALL participants: - endurance athlete (cyclist, runner, triathlete or other) who participate in vigorous year-round training of 4-6 hours per week for a minimum of 20 years - participation in atleast one major competition per year (marathon/triathlon/endurance competition) - sinus rhythm during all assessments Inclusion criteria specific to endurance athletes with AF: - diagnosed with lone paroxysmal AF in the last 4 years - able to verify diagnosis (ECG or Holter verification/proof of diagnosis), - can be on any type of medication. Inclusion criteria specific to healthy endurance athletes without AF: - previous participation in Athlete's Heart Study - has completed resting cardiac magnetic resonance imaging and resting electrocardiogram Exclusion Criteria: - females - no more than >1 hour per week of resistance training - treatment or prior diagnosis of cardiovascular disease, valvular disease, hypertension, heart failure, diabetes, thyroid disorder, sleep apnea, current/recent viral disease, chronic inflammatory disease - previous (within 10 years) or current smoking - recreational drug use or alcohol consumption in excess of accepted standards - inability to provide informed consent - inability to verify AF diagnosis (if AF athlete). |
Country | Name | City | State |
---|---|---|---|
Canada | Goldring Center for High Performance | Toronto | Ontario |
Lead Sponsor | Collaborator |
---|---|
University of Toronto | St. Michael's Hospital, Toronto |
Canada,
Calvo N, Brugada J, Sitges M, Mont L. Atrial fibrillation and atrial flutter in athletes. Br J Sports Med. 2012 Nov;46 Suppl 1:i37-43. doi: 10.1136/bjsports-2012-091171. Review. — View Citation
Grimsmo J, Grundvold I, Maehlum S, Arnesen H. High prevalence of atrial fibrillation in long-term endurance cross-country skiers: echocardiographic findings and possible predictors--a 28-30 years follow-up study. Eur J Cardiovasc Prev Rehabil. 2010 Feb;17(1):100-5. doi: 10.1097/HJR.0b013e32833226be. — View Citation
Molina L, Mont L, Marrugat J, Berruezo A, Brugada J, Bruguera J, Rebato C, Elosua R. Long-term endurance sport practice increases the incidence of lone atrial fibrillation in men: a follow-up study. Europace. 2008 May;10(5):618-23. doi: 10.1093/europace/eun071. Epub 2008 Apr 4. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Lifetime hours of Physical Activity (# of hours) | Total lifetime hours of physical activity will be assessed using the Lifetime Physical Activity Questionnaire (LTPAQ). | baseline (day 1: at first visit, one time measure) | |
Other | Maximal oxygen consumption (VO2 max) | Maximal oxygen consumption (VO2 max) will be determined using a maximal treadmill test, in which a calibrated metabolic cart and indirect calorimetry will be used. VO2 max will be expressed as ml/kg/min. | baseline (day 1: at first visit, one time measure) | |
Primary | Left intra-atrial electromechanical delay (ms) | Left intra-atrial electromechanical delay will be measured using cardiac echocardiography at rest and during submaximal cycling. Left intra-atrial electromechanical delay will be measured as the time interval between the initiation of the P wave (on an electrocardiogram) to the beginning of the late diastolic wave (Am wave) on echocardiography. | baseline (day 1: at first visit, one time measure) | |
Secondary | Left atrial reservoir function | Left atrial reservoir function will be measured by Speckle Tracking echocardiography, at 60-80 frames per second. Left atrial reservoir function will be measured by assessing left atrial reservoir strain (%), measured during ventricular systole on echocardiography. | baseline (day 1: at first visit, one time measure) | |
Secondary | Left atrial volume (mL) | Left atrial volume (mL) will be measured using echocardiography at the end of ventricular systole, prior to the opening of the mitral valve. Imaging will be acquired using two and four chamber views. | baseline (day 1: at first visit, one time measure) |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT05970120 -
A Study of Intracardiac Ultrasound With the NUVISION NAV Ultrasound Catheter
|
N/A | |
Recruiting |
NCT06014996 -
Comparison of PFA vs. RFA in Patients With Symptomatic Paroxysmal Atrial Fibrillation.
|
N/A | |
Completed |
NCT03624881 -
Evaluation of VISITAG SURPOINT™ Module With External Processing Unit (EPU)
|
Phase 4 | |
Recruiting |
NCT05416086 -
iCLAS™ Cryoablation System Post-Market Clinical Follow-up (PMCF) Study
|
N/A | |
Recruiting |
NCT05905835 -
Treatment of PAF With the Synaptic System
|
N/A | |
Active, not recruiting |
NCT05618340 -
PFA for Paroxysmal Atrial Fibrillation
|
N/A | |
Active, not recruiting |
NCT05534581 -
SINGLE SHOT CHAMPION
|
Phase 4 | |
Not yet recruiting |
NCT05024630 -
Renal Denervation and pUlmonary Vein isolAtion With cryoabLation on Patients With Atrial Fibrillation and hypErtension
|
N/A | |
Completed |
NCT01913522 -
Cryoballoon vs. Irrigated Radiofrequency Catheter Ablation: Double Short vs. Standard Exposure Duration
|
N/A | |
Completed |
NCT02610803 -
Paroxysmal Atrial Fibrillation in Patients With Acute Ischemic Stroke
|
N/A | |
Withdrawn |
NCT01917981 -
Testing the Accuracy of a Personal Heart Rhythm Monitor to Detect Prolonged Paroxysmal Atrial Fibrillation
|
Phase 3 | |
Terminated |
NCT01925885 -
Focal Impulse and Rotor Modulation Ablation Trial for Treatment of Paroxysmal Atrial Fibrillation (FIRMAT-PAF)
|
N/A | |
Completed |
NCT01842529 -
Botulinum Toxin Injection in Epicardial Fat Pads To Treat Atrial Fibrillation After Cardiac Surgery
|
Phase 2 | |
Completed |
NCT01693107 -
Atrial Fibrillation Force Contact Ablation Study
|
||
Completed |
NCT00971204 -
Clinical Study of the CardioFocus Endoscopic Ablation System - Adaptive Contact (EAS-AC) for the Treatment of Symptomatic Atrial Fibrillation
|
Phase 2 | |
Completed |
NCT05043883 -
Automated Assessment of PVI Using a Novel EP Recording System
|
N/A | |
Recruiting |
NCT05172765 -
Biomarker-Guided Optimization of Transcutaneous Vagal Stimulation for Atrial (BiG tVNS-AF)
|
N/A | |
Recruiting |
NCT04529785 -
Added Value of Vein of Marshal Ethanol Infusion Compared to Superior Vena Cava Isolation Alone in Patients Undergoing Repeat Ablation for Recurrent Paroxysmal Atrial Fibrillation Despite Durable PV Isolation
|
N/A | |
Completed |
NCT04022954 -
HD Mapping of Atrial Fibrillation in Asia Pacific
|
||
Completed |
NCT00964392 -
NAVISTAR® THERMOCOOL® Catheter Post Approval Registry
|
Phase 4 |