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Reversal of Atrial Substrate to Prevent Atrial (RASTA AF)

Primary Purpose

Atrial Fibrillation

Status

Recruiting

Phase

Not Applicable

Locations

Canada

Study Type

Interventional

Intervention

Aggressive Risk Factor Control

Standard of Care

About this trial

This is an interventional treatment trial for Atrial Fibrillation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Patients with symptomatic (CCS-SAF ≥2) paroxysmal or persistent atrial fibrillation despite rate control, desiring catheter ablation and at least two of the following:

BMI>27,
BP>140/90 mmHg or history of hypertension,
Prior stroke/transient ischemic attack,
Diabetes,
Heart failure (prior heart failure admission or left ventricle ejection fraction (LVEF) <40%),
Age ≥ 65 years.

Exclusion Criteria:

Left atrial size > 5.5 cm,
New York Heart Association (NYHA) Class IV (Severe) heart failure,
Participation in a cardiac rehabilitation program within the last year,
Currently performing exercise training >150 minutes/week of moderate to vigorous physical activity,
Unable to exercise,
Unable to give informed consent,
Other noncardiovascular medical condition making 1 year survival unlikely,
Less than 18 years of age.

Sites / Locations

QE II Health Sciences CentreRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Aggressive Risk Factor Control

Standard of Care

Arm Description

Multifaceted risk factor management relating to BP, exercise, sleep apnea, alcohol intake and diabetes management

All patients in the control arm will receive therapies for AF as per the existing guidelines. BP, cholesterol, diabetic management will be administered as per the available guidelines.

Outcomes

Primary Outcome Measures

Number of AF related hospitalizations post ablation

AF-related hospitalizations (lasting more than 24 hours) from 2-months post ablation to end of follow up.

Number of AF related Emergency Department (ED) visits post ablation

AF-related emergency department visits from 2-months post ablation to end of follow up.

Number of clinically significant AF events post ablation

Clinically significant AF events lasting >24 hours (either an irregular R-R interval, or atrial cycle length < 280 ms, as obtained from an insertable cardiac monitor) from 2-months post ablation to end of follow up.

Secondary Outcome Measures

Number of AF-related hospitalizations

AF-related hospitalizations (lasting more than 24 hours) from randomization to end of follow up.

Number of AF-related emergency department (ED) visits

AF-related emergency department visits from randomization to end of follow up.

Number of Clinically significant AF events

Clinically significant AF events lasting >24 hours (either an irregular R-R interval, or atrial cycle length < 280 ms, as obtained from an insertable cardiac monitor) from randomization to end of follow up.

Mean AF burden

Average percentage of time in AF during follow up, as measured by insertable cardiac monitor.

Stroke or systemic embolism events

Total number of stoke or systemic embolism events.

Quality of Life - CCS-SAF

Symptom burden as measured by the Canadian Cardiovascular Society (CCS) Severity of Atrial Fibrillation (SAF) scale. CCS-SAF scores range from 0 to 4, with higher values representing more severe impact of symptoms on quality of life and activities of daily living.

Quality of Life - AFEQT

Quality of life as measured by the Atrial Fibrillation Effect on QualiTy-of-life (AFEQT) scale. The scale consists of 21 questions with 7-point Likert scale responses. Questions 1-18 are grouped into three subscales (symptoms, daily activities and treatment concern). Questions 19-21 capture satisfaction with treatment and are not include in the HRQoL score of the questionnaire. Overall and subscale scores range from 0 to 100. Lower scores correspond to higher levels of disability (e.g., 0 corresponds to complete disability or responding "extremely" limited, difficult or bothersome to all questions answered), while a score of 100 corresponds to no disability (e.g., responding "not at all" limited, difficult or bothersome to all questions answered). For Satisfaction questions, a score of 100 corresponds to extreme satisfaction with current treatment.

Number of recurrent AF-ablations

Number of re-ablations required.

Cardioversions

Number of cardioversions required.

All-cause mortality

Any deaths occurring at any time during the study.

Full Information

NCT ID

NCT03682991

First Posted

August 27, 2018

Last Updated

February 1, 2023

Sponsor

Nova Scotia Health Authority

Collaborators

Canadian Institutes of Health Research (CIHR), Abbott, Ottawa Heart Institute Research Corporation

1. Study Identification

Unique Protocol Identification Number

NCT03682991

Brief Title

Reversal of Atrial Substrate to Prevent Atrial

Acronym

RASTA AF

Official Title

Reversal of Atrial Substrate to Prevent Atrial Fibrillation

Study Type

Interventional

2. Study Status

Record Verification Date

February 2023

Overall Recruitment Status

Recruiting

Study Start Date

July 1, 2019 (Actual)

Primary Completion Date

June 2024 (Anticipated)

Study Completion Date

June 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Nova Scotia Health Authority

Collaborators

Canadian Institutes of Health Research (CIHR), Abbott, Ottawa Heart Institute Research Corporation

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

A multi-center, randomized trial to examine the effect of aggressive risk factor control and arrhythmia trigger-based intervention on recurrence of atrial fibrillation.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Atrial Fibrillation

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

This will be a parallel group, open label randomized clinical trial, with blinded endpoint evaluation (PROBE design)

Masking

None (Open Label)

Allocation

Randomized

Enrollment

670 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Aggressive Risk Factor Control

Arm Type

Experimental

Arm Description

Multifaceted risk factor management relating to BP, exercise, sleep apnea, alcohol intake and diabetes management

Arm Title

Standard of Care

Arm Type

Active Comparator

Arm Description

All patients in the control arm will receive therapies for AF as per the existing guidelines. BP, cholesterol, diabetic management will be administered as per the available guidelines.

Intervention Type

Other

Intervention Name(s)

Aggressive Risk Factor Control

Intervention Description

Sleep apnea screening, therapy is recommended if apopnea-hypopnea (AHI) index is greater than 15, with a target index of less than 5. Counseling regarding alcohol reduction to 2 drinks/day for men, 1 drink/day for women, no binge drinking (>5 drinks at one setting). Participation in a 12 week structured, home-based exercise program and nutritional counseling. Weight reduction will be emphasized through modification of diet and exercise. Blood Pressure management to achieve a target systolic blood pressure (SBP) of <120/80 mm/Hg Smoking cessation facilitated through local resources already established at each site

Intervention Type

Other

Intervention Name(s)

Standard of Care

Intervention Description

Recommendations based on current guidelines

Primary Outcome Measure Information:

Title

Number of AF related hospitalizations post ablation

Description

AF-related hospitalizations (lasting more than 24 hours) from 2-months post ablation to end of follow up.

Time Frame

up to 48 months

Title

Number of AF related Emergency Department (ED) visits post ablation

Description

AF-related emergency department visits from 2-months post ablation to end of follow up.

Time Frame

up to 48 months

Title

Number of clinically significant AF events post ablation

Description

Time Frame

up to 48 months

Secondary Outcome Measure Information:

Title

Number of AF-related hospitalizations

Description

AF-related hospitalizations (lasting more than 24 hours) from randomization to end of follow up.

Time Frame

up to 48 months

Title

Number of AF-related emergency department (ED) visits

Description

AF-related emergency department visits from randomization to end of follow up.

Time Frame

up to 48 months

Title

Number of Clinically significant AF events

Description

Time Frame

up to 48 months

Title

Mean AF burden

Description

Average percentage of time in AF during follow up, as measured by insertable cardiac monitor.

Time Frame

up to 48 months

Title

Stroke or systemic embolism events

Description

Total number of stoke or systemic embolism events.

Time Frame

up to 48 months

Title

Quality of Life - CCS-SAF

Description

Time Frame

Up to 24 months

Title

Quality of Life - AFEQT

Description

Time Frame

Up to 24 months

Title

Number of recurrent AF-ablations

Description

Number of re-ablations required.

Time Frame

up to 48 months

Title

Cardioversions

Description

Number of cardioversions required.

Time Frame

up to 48 months

Title

All-cause mortality

Description

Any deaths occurring at any time during the study.

Time Frame

up to 48 months

Other Pre-specified Outcome Measures:

Title

Number of ablation procedural complications [Safety]

Description

Periprocedural complications will be assessed.

Time Frame

up to 48 months

Title

Number of antiarrhythmic drug adverse effects [Safety]

Description

Adverse drug reactions will be assessed.

Time Frame

up to 48 months

Title

Exercise compliance - IPAQ

Description

Compliance to exercise recommendations will be measured by the International Physical Activity Questionnaire (IPAQ) which calculates a metabolic equivalent (MET) score by asking participants the days and minutes exercised in three categories of intensity (vigorous, moderate, and walking) during the previous one week. MET values are as follows: walking = 3.3, moderate activity = 4, vigorous activity = 8). Results will be reported as a continuous variable (MET minutes a week) calculated by multiplying the MET value by the minutes the activity was carried out and the number of days the activity was undertaken. MET minutes achieved in each category will be added to get the total MET minutes of physical activity a week.

Time Frame

up to 24 months

Title

Sleep apnea therapy compliance

Description

Apopnea-hypopnea index (AHI) as measured on a continuous positive airway pressure (CPAP) machine. AHI is calculated by dividing the number of apnea events by the number of hours of sleep. AHI values for adults are: normal (AHI<5); mild (5≤AHI<15); moderate (15≤AHI<30) and severe (AHI≥30)

Time Frame

up to 48 months

Title

Systolic Blood pressure target achievement

Description

Assessed at each follow up to determine if the target SBP of <120/80 mm/Hg has been achieved.

Time Frame

up to 48 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Patients with symptomatic (CCS-SAF ≥2) paroxysmal or persistent atrial fibrillation despite rate control, desiring catheter ablation and at least two of the following: BMI>27, BP>140/90 mmHg or history of hypertension, Prior stroke/transient ischemic attack, Diabetes, Heart failure (prior heart failure admission or left ventricle ejection fraction (LVEF) <40%), Age ≥ 65 years. Exclusion Criteria: Left atrial size > 5.5 cm, New York Heart Association (NYHA) Class IV (Severe) heart failure, Participation in a cardiac rehabilitation program within the last year, Currently performing exercise training >150 minutes/week of moderate to vigorous physical activity, Unable to exercise, Unable to give informed consent, Other noncardiovascular medical condition making 1 year survival unlikely, Less than 18 years of age.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Ratika Parkash, MD FRCPC

Phone

902-474-4474

Ratika.Parkash@nshealth.ca

First Name & Middle Initial & Last Name or Official Title & Degree

Laura M Hamilton, BSc MAHSR

Phone

902-473-7226

Laura.Hamilton@nshealth.ca

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ratika Parkash

Organizational Affiliation

Nova Scotia Health Authority

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Allan Skanes

Organizational Affiliation

London Health Sciences Centre

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Chris Blanchard

Organizational Affiliation

Nova Scotia Health Authority

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Bob Reid

Organizational Affiliation

University of Ottawa Heart Institution

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

David Birnie

Organizational Affiliation

University of Ottawa Heart Institution

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

George Wells

Organizational Affiliation

University of Ottawa Heart Institution

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Isabelle VanGelder

Organizational Affiliation

University of Groningen

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Jeff Healey

Organizational Affiliation

Hamilton Health Sciences Centre

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Jennifer Reed

Organizational Affiliation

University of Ottawa Heart Institution

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Anthony Tang

Organizational Affiliation

London Health Sciences Centre

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

John Sapp

Organizational Affiliation

Nova Scotia Health Authority

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Vidal Essebag

Organizational Affiliation

McGill University Hospital

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Stephen Wilton

Organizational Affiliation

Foothills Hospital

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Paul Dorian

Organizational Affiliation

Unity Health Toronto

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Anne Gillis

Organizational Affiliation

Foothills Hospital

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Lena Rivard

Organizational Affiliation

Montreal Heart Institute

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Nicholas Giacomantonio

Organizational Affiliation

Nova Scotia Health Authority

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Ben Glover

Organizational Affiliation

Sunnybrook Hospital

Official's Role

Study Director

Facility Information:

Facility Name

QE II Health Sciences Centre

City

Halifax

State/Province

Nova Scotia

ZIP/Postal Code

B3H 3A7

Country

Canada

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Ratika Parkash

First Name & Middle Initial & Last Name & Degree

Ratika Parkash, MD MSc

12. IPD Sharing Statement

Plan to Share IPD

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Reversal of Atrial Substrate to Prevent Atrial

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