Reversal of Atrial Substrate to Prevent Atrial

NCT03682991 | Active Not Recruiting DMC

• 1 other identifier: RP-007
• Study Type: interventional
• Target: 509
• Locations: 1 country
• Sites: 17

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.

Conditions

Atrial Fibrillation

Outcome Measures

Primary Outcomes (3)

• 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.

  up to 72 months

• 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.

  up to 72 months

• 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.

  up to 72 months

Secondary Outcomes (14)

• Number of AF-related hospitalizations

  up to 72 months

• Number of AF-related emergency department (ED) visits

  up to 72 months

• Number of Clinically significant AF events

  up to 72 months

• Mean AF burden

  up to 72 months

• Stroke or systemic embolism events

  up to 72 months

Other Outcomes (3)

• Number of ablation procedural complications [Safety]

  up to 72 months

• Number of antiarrhythmic drug adverse effects [Safety]

  up to 72 months

• Death (Safety)

  Up to 72 months

Study Arms (2)

Aggressive Risk Factor Control

EXPERIMENTAL

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

Other: Aggressive Risk Factor Control

Standard of Care

ACTIVE COMPARATOR

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.

Other: Standard of Care

Interventions

Aggressive Risk Factor Control OTHER

1. Sleep apnea screening, therapy is recommended if apopnea-hypopnea (AHI) index is greater than 15, with a target index of less than 5. 2. Counseling regarding alcohol reduction to 2 drinks/day for men, 1 drink/day for women, no binge drinking (\>5 drinks at one setting). 3. Participation in a 12 week structured, home-based exercise program and nutritional counseling. Weight reduction will be emphasized through modification of diet and exercise. 4. Blood Pressure management to achieve a target systolic blood pressure (SBP) of \<120/80 mm/Hg 5. Smoking cessation facilitated through local resources already established at each site

Aggressive Risk Factor Control

Standard of Care OTHER

Recommendations based on current guidelines

Standard of Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Current smoker
• Excessive Alcohol use

You may not qualify if:

• Permanent AF (AF lasting \> 3 years)
• Prior catheter ablation for AF
• 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.

Sponsors & Collaborators

• Abbott: collaborator
• Cardiac Arrhythmia Network of Canada: collaborator
• Nova Scotia Health Authority: lead
• Canadian Institutes of Health Research (CIHR): collaborator
• Philips Healthcare: collaborator

Study Sites (17)

Foothills Hospital

Calgary, Alberta, Canada

Location

Mazankowski Alberta Heart Institute

Edmonton, Alberta, Canada

Location

Kelowna General Health

Kelowna, British Columbia, Canada

Location

St. Paul's Hospital

Vancouver, British Columbia, Canada

Location

Saint John Regional Hospital

Saint John, New Brunswick, Canada

Location

QE II Health Sciences Centre

Halifax, Nova Scotia, B3H 3A7, Canada

Location

Hamilton Health Sciences Center

Hamilton, Ontario, Canada

Location

St. Mary's General Hospital

Kitchener, Ontario, Canada

Location

London Health Sciences Center

London, Ontario, Canada

Location

Ottawa Heart Institute

Ottawa, Ontario, Canada

Location

St. Michael's Hospital

Toronto, Ontario, Canada

Location

Sunnybrook Health Sciences Centre

Toronto, Ontario, Canada

Location

Laval Hospital

Laval, Quebec, Canada

Location

McGill University Health Centre

Montreal, Quebec, Canada

Location

Montreal Heart Institute

Montreal, Quebec, Canada

Location

Sacre Coeur Hospital

Montreal, Quebec, Canada

Location

Regina General Hospital

Regina, Saskatchewan, Canada

Location

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Ratika Parkash

  Nova Scotia Health Authority

  PRINCIPAL INVESTIGATOR

• Allan Skanes

  London Health Sciences Centre

  STUDY DIRECTOR

• Chris Blanchard

  Nova Scotia Health

  STUDY DIRECTOR

• David Birnie

  University of Ottawa Heart Institution

  STUDY DIRECTOR

• George Wells

  University of Ottawa Heart Institution

  STUDY DIRECTOR

• Michiel Rienstra

  University of Groningen

  STUDY DIRECTOR

• Jeff Healey

  Hamilton Health Sciences Centre

  STUDY DIRECTOR

• Jennifer Reed

  University of Ottawa Heart Institution

  STUDY DIRECTOR

• Anthony Tang

  London Health Sciences Centre

  STUDY DIRECTOR

• Vidal Essebag

  McGill University Hospital

  STUDY DIRECTOR

• Isabelle vanGelder

  University of Groningen

  STUDY DIRECTOR

• John Sapp

  Nova Scotia Health Authority

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending Staff, Department of Medicine

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

Study Record Dates

• First Submitted: August 27, 2018
• First Posted: September 25, 2018
• Study Start: July 1, 2019
• Primary Completion (Estimated): September 15, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: February 17, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

CA (17)