Clinical Trials Logo

Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT03467633
Other study ID # 20170868
Secondary ID
Status Terminated
Phase N/A
First received
Last updated
Start date April 25, 2018
Est. completion date October 8, 2020

Study information

Verified date October 2020
Source Ottawa Heart Institute Research Corporation
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This is a study looking at the feasibility of conducting a larger definitive research trial looking at the effectiveness of high intensity interval training in individuals who are scheduled for electro-cardioversion. Usual care for these participants is to go home and continue with their typical daily routine. The investigators will test whether participating in 3-weeks of thrice-weekly high intensity interval training before electro-cardioversion can lengthen the time to recurrence of atrial fibrillation after electro-cardioversion in these individuals. Participants will be asked to come to the University of Ottawa Heart Institute for a baseline visit at which fitness (cycle ergometer), body composition (weight, height, waist circumference and percentage body fat), heart rate variability and habitual exercise levels will be measured. Participants will then be randomized to either the exercise group or the usual care group. Those randomized to the usual care group will go home for 3-weeks and continue with their typical daily routine. Those randomized to the exercise group will return to the Heart Institute three times per week for 3-weeks to participate in a high intensity interval training program prior to their electro-cardioversion. All participants will be asked to measure daily heart rate and rhythm using the AliveCor system which is compatible with their Smartphones, for up to 12-months following their electro-cardioversion. All participants will be asked to return at 3-weeks (and prior to their electro-cardioversion) to measure fitness (cycle ergometer), body composition (weight, height, waist circumference and percentage body fat), and habitual exercise levels. The entire study should last approximately 24-months. Participants will be involved for 52-weeks. The investigators are looking to recruit 20 participants total for the feasibility trial. The investigators hypothesize that recruitment rates, drop-out rates, and adherence to the intervention will support a larger definitive trial.


Description:

This is a study looking at the feasibility of conducting a larger definitive research trial looking at the effectiveness of high intensity interval training on lengthening time to recurrence of persistent atrial fibrillation in individuals who are scheduled for electro-cardioversion. Usual care for these participants is to go home and continue with their typical daily routine until their scheduled cardioversion. The investigators will test whether participating in 3-weeks of thrice-weekly high intensity interval training before electro-cardioversion can lengthen the time to recurrence of atrial fibrillation after electro-cardioversion in these individuals. Participants will be asked to come to the University of Ottawa Heart Institute for a baseline visit at which fitness (cycle ergometer), body composition (weight, height, waist circumference and percentage body fat), and habitual exercise levels will be measured. Participants will then be randomized to either the exercise group or the usual care group. Those randomized to the usual care group will go home for 3-weeks and continue with their typical daily routine. Those randomized to the exercise group will return to the Heart Institute three times per week for 3-weeks to participate in a high intensity interval training cycle ergometer program prior to their electro-cardioversion. All participants will be asked to return at 3-weeks (and prior to their electro-cardioversion) to measure fitness (cycle ergometer), body composition (weight, height, waist circumference and percentage body fat), and habitual exercise levels. Following the electro-cardioversion, all participants will be asked to measure daily heart rate and rhythm using the AliveCor system which is compatible with their Smartphones/tablets/iPads, for up to 12-months or until they return to persistent atrial fibrillation. The entire study should last approximately 24-months. Participants will be involved for a maximum of 52-weeks. The investigators are looking to recruit a total of 20 participants for the feasibility trial. The investigators hypothesize that recruitment rates, drop-out rates, and adherence to the intervention will support a larger definitive trial.


Recruitment information / eligibility

Status Terminated
Enrollment 12
Est. completion date October 8, 2020
Est. primary completion date October 8, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years to 85 Years
Eligibility Inclusion Criteria: 1. Persistent atrial fibrillation 2. Eligible and scheduled for electro-cardioversion at UOHI 3. Rate controlled with a resting ventricular rate of equal to or less than 100bpm 4. Between 18-85 years of age 5. Owns a Smartphone 6. Physically able to participate in exercise 7. Willing and able to provide written, informed consent 8. Willing and able to return for follow-up visits 9. Willing and able to provide daily ECG recordings using the AliveCor system for the duration of the study. Exclusion Criteria: 1. Participating in routine exercise training (more than two times per week) in the past 3 months 2. Atrial Flutter secondary to ablation 3. Unstable angina 4. Diagnosed with severe mitral or aortic stenosis, hypertrophic obstructive cardiomyopathy 5. Pregnant, lactating or planning to become pregnant during the study period 6. Diagnosed with rheumatic heart disease

Study Design


Intervention

Behavioral:
High-intensity interval training
Participants in the HIIT group will receive 3-weeks of tri-weekly supervised exercise sessions at the UOHI prior to their scheduled electro-cardioversion. The session will last 23 minutes in duration and consist of a 2-minute warm-up at 50% of peak power output (PPO), 2 x 8-minute interval training blocks of 30 seconds at 80-100% of PPO interspersed with 30-seconds of active recovery and a 1-minute cool down at 25 % of PPO. The sessions will be lead by a Registered Kinesiologist.

Locations

Country Name City State
Canada University of Ottawa Heart Institute Ottawa Ontario

Sponsors (2)

Lead Sponsor Collaborator
Ottawa Heart Institute Research Corporation Cardiac Arrhythmia Network of Canada

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary Feasibility - recruitment rates recruitment rates 52-weeks
Primary Feasibility - loss to follow-up and drop-out rates loss to follow-up and drop-out rates 52-weeks
Primary Feasibility - reasons for drop-out reasons for drop-out 52-weeks
Primary Feasibility - adherence to study procedures adherence to study procedures including daily AliveCor measures 52-weeks
Primary Feasibility - attendance at thrice-weekly HIIT sessions attendance at thrice-weekly HIIT sessions 3-weeks
Secondary Time to recurrence of atrial fibrillation Time to recurrence will be measured with a daily ECG recording up to 52-weeks from randomization, using the AliveCor system and Smartphone. Up to 52 weeks after electro-cardioversion.
Secondary Physical Activity levels Participants will also be asked to complete a questionnaire related to habitual physical activity (modified Godin) at baseline and follow-up. The modified Godin asks participants to recall the last 7 days and report the number of days and the number of minutes per day they participated in mild, moderate and vigorous bouts of physical activity. These values are then multiplied together to calculate minutes/week of mild physical activity and minutes/ week of moderate-to-vigorous intensity physical activity. 3-weeks
Secondary Fitness Participants will complete a CPET at baseline and 3-weeks to assess fitness level using a pre-determined protocol on a cycle ergometer (Oxycon mobile, CareFusion, USA). 3-weeks
Secondary Clinical outcomes Body composition will be assessed: height 3-weeks
Secondary Weight Body composition will be assessed: weight 3-weeks
Secondary Waist Circumference Body composition will be assessed: waist circumference 3-weeks
Secondary Body Mass Index Body composition will be assessed: body mass index 3-weeks
Secondary Body Fat Body composition will be assessed:body fat percentage 3-weeks
See also
  Status Clinical Trial Phase
Completed NCT05970120 - A Study of Intracardiac Ultrasound With the NUVISION NAV Ultrasound Catheter N/A
Recruiting NCT05416086 - iCLAS™ Cryoablation System Post-Market Clinical Follow-up (PMCF) Study N/A
Completed NCT03650556 - Safety and Effectiveness of TactiCath™ Contact Force, Sensor Enabled™ (TactiCath SE) Catheter for Ablation of Drug Refractory, Symptomatic, Persistent Atrial Fibrillation N/A
Recruiting NCT04085731 - Driver-guided Ablation of Persistent Atrial Fibrillatiom
Withdrawn NCT02344394 - Comparison of Hybrid Ablation and Pulmonary Vein Isolation Alone vs Hybrid Ablation With PVI Plus Catheter Ablation N/A
Terminated NCT01683045 - Efficacy and Safety Study of the Estech COBRA® Surgical System to Treat Patients With a History of Irregular Heart Beats N/A
Completed NCT01694563 - ABLATE Post Approval Study - Synergy Ablation Lesions for Non-Paroxysmal Atrial Fibrillation N/A
Active, not recruiting NCT03643224 - DiamondTemp™ System for the Treatment of Persistent Atrial Fibrillation N/A
Withdrawn NCT05093868 - Electrographic Flow Mapping Validation in Patients With Persistent Atrial Fibrillation (EVAL AF) N/A
Completed NCT05152966 - Feasibility Study of the FARAPULSE™ Cardiac Ablation System Plus in the Treatment of Persistent Atrial Fibrillation(PersAFOne II) N/A
Completed NCT05043883 - Automated Assessment of PVI Using a Novel EP Recording System N/A
Completed NCT04022954 - HD Mapping of Atrial Fibrillation in Asia Pacific
Active, not recruiting NCT06124690 - Persistent Atrial Fibrillation Without the Evidence of Low-voltage Areas N/A
Completed NCT06260670 - FLOW EVAL-AF: FLOW Mapping Electrogram VALidation in Patients With Persistent Atrial Fibrillation N/A
Not yet recruiting NCT05454111 - CARTO-Finder Guided Ablation Versus Multiscale Entropy Guided Ablation in Persistent Atrial Fibrillation N/A
Active, not recruiting NCT05077670 - Hybrid Characterization of Driver Sites During Atrial Fibrillation and Sinus Rhythm
Withdrawn NCT03835338 - WATCHMAN for Concomitant Left Atrial Appendage Electrical Isolation and Occlusion to Treat Persistent Atrial Fibrillation Rhythm N/A
Completed NCT02275104 - Multimodal Image Processing Software to Guide Cardiac Ablation Therapy N/A
Not yet recruiting NCT05565183 - Combined Study of ATrial Strain and Voltage by High Density Mapping in Young Patients With Atrial Fibrillation. N/A
Completed NCT02274857 - Randomized Evaluation of Atrial Fibrillation Treatment With Focal Impulse and Rotor Modulation Guided Procedures N/A