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First Line Radiofrequency Ablation Versus Antiarrhythmic Drugs for Atrial Fibrillation Treatment (The RAAFT Study) (RAAFT)

Primary Purpose

Atrial Fibrillation

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Pulmonary Vein Isolation performed by Catheter Ablation

Conventional Antiarrhythmic Drug Therapy

About this trial

This is an interventional treatment trial for Atrial Fibrillation focused on measuring Atrial Fibrillation, Paroxysmal, Pulmonary Vein Isolation, Ablation Catheter, Anti-arrhythmic Drug Therapy, First Line Therapy

Eligibility Criteria

19 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Age > 18 and ≤ 75 years old.
Symptomatic, recurrent paroxysmal AF lasting > 30 seconds (at least 4 episodes within the prior 6 months). At least one episode must be documented by Holter,12-lead ECG, event monitor or rhythm strip.

Exclusion Criteria:

Documented LVEF <40%.
Documented left atrial diameter >5.5cm.
Moderate to severe LVH (LV wall thickness >1.5cm).
Documented valvular disease, coronary heart disease (defined as the presence of >70% stenosis of coronary arteries or documentation of active myocardial ischemia), post-CABG, postoperative cardiac surgery or peripheral artery disease.
Documented AF with electrical cardioversion where full therapeutic antiarrhythmic drug therapy after the cardioversion was prescribed.
Untreated hypothyroidism or hyperthyroidism. Patients who are euthyroid on thyroid hormone replacement therapy are acceptable.
Contraindication for the use of sotalol, dofetilide and 1C antiarrhythmic drugs(liver enzymes and serum creatinine that are outside the upper normal lab values, e.g. > 3 times ULN with 2 abnormal lab values).
Previous left heart ablation procedure, either by surgery or by percutaneous catheter, for atrial fibrillation.
Current enrollment in another investigational drug or device study.
Presence of any other condition that the investigator feels would be problematic or would restrict or limit the participation of the Patient for the entire study period.
Absolute contra-indication to the use of heparin and or warfarin.
Increase risk of bleeding, current peptic ulceration, proliferative diabetic retinopathy, history of severe systemic bleeding, or other history of bleeding diathesis or coagulopathy.
Severe pulmonary disease e.g. restrictive pulmonary disease, chronic obstructive disease (COPD).
Documented intra-atrial thrombus, tumor, or another abnormality which precludes catheter introduction.
Previous use of full therapeutic dose of an antiarrhythmic drug, including amiodarone, propafenone, flecainide, sotalol, quinidine.
Pacemaker or Implantable Cardioverter Defibrillator.
Women with a positive pregnancy test.
Evidence of active cardiac or systemic infection.
Medical condition limiting expected survival to less than one year.

Sites / Locations

Texas Cardiac Arrhythmia Foundation
Austin Heart
Victoria Cardiac Arrhythmia Trials Inc.
Hamilton General Hospital
London Health Sciences Centre University Hospital
Southlake Regional Health Centre
Sunnybrook Health Sciences Centre
Montreal Heart Institute
McGill University
Institut Universitaire de Cardiologie et Pneumologie de Québec
Institute for Clinical and Experimental Medicine
Charles University
Abteilung Rhythmologie
Asklepios Klinik St. Georg
University Hospital Eppendorf
F. Miulli Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Catheter Ablation

Antiarrhythmic Drug Therapy

Arm Description

Pulmonary vein isolation performed by catheter ablation for the prevention of recurrence of symptomatic atrial fibrillation

Conventional antiarrythmic drug therapy for the prevention of recurrence of symptomatic atrial fibrillation

Outcomes

Primary Outcome Measures

Number of Participants With Recurrence of Atrial Tachyarrhythmia

Recurrence of electrocardiographically documented atrial fibrillation, atrial flutter or atrial tachycardia lasting >30 seconds during Follow-up Period. The follow-up period begins 90 days after randomization (the blanking period during which antiarrhythmic drugs are titrated or catheter ablation is performed).

Comparison of Proportion of Patients With an Occurrence of Any of a Cluster of Serious Complications in Either Arm

Ablation arm cluster: death, cardiac tamponade, severe PV stenosis>70%, atrioesophageal fistula, thromboembolism, vascular complications (i.e. arterial pseudoaneurysm, arteriovenous fistula and hematoma leading to transfusion), phrenic nerve injury or complete AV block requiring permanent pacemaker implantation. Antiarrhythmic drug arm cluster: Death, torsade de pointes, bradycardia leading to pacemaker insertion, syncope, QRS duration prolongation > 50% of baseline, 1:1 atrial flutter or any other significant adverse events that leads to drug discontinuation.

Secondary Outcome Measures

Number of Participants With Recurrence of Symptomatic Atrial Tachyarrhythmia

Including only symptomatic episodes of all atrial tachyarrhythmias (atrial fibrillation, atrial flutter and atrial tachycardia). The follow-up period begins 90 days after randomization (the blanking period during which antiarrhythmic drugs are titrated or catheter ablation is performed).

Number of Participants With Recurrence of Symptomatic Atrial Fibrillation

Including only symptomatic episodes of atrial fibrillation in the outcome measure (excluding asymptomatic events and events adjudicated as atrial flutter or atrial tachycardia). The follow-up period begins 90 days after randomization (the blanking period during which antiarrhythmic drugs are titrated or catheter ablation is performed).

Episodes of ANY Recurrence of Atrial Tachyarrhythmia

Including all episodes of symptomatic or asymptomatic atrial fibrillation, atrial flutter and atrial tachycardia. The follow-up period begins 90 days after randomization (the blanking period during which antiarrhythmic drugs are titrated or catheter ablation is performed).

Number of Participants With Recurrence of Atrial Tachyarrhythmia Obtained Clinically

Including only events documented by 12 lead ECG, Holter monitoring or rhythm strips but excluding TTM monitoring. The follow-up period begins 90 days after randomization (the blanking period during which antiarrhythmic drugs are titrated or catheter ablation is performed).

Quality of Life EQ5D Index Score

The standard EQ-5D questionnaire is completed by study participants. The EQ-5D Index score is a descriptive system comprising five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Self-reported severity for each dimension is given on a 3 level scale: (1) no problems, (2) some problems or (3) major problems. For example a health state: 11223 means: no problems with mobility (1), no problems with self-care (1), some problems with performing usual activity (2), moderate pain/discomfort (2), and major anxiety/depression (3). Thus there are 243 patterns of health state: 11111 to 33333. Scores are converted to a single weighted index score (utility). The index score is derived by applying a formula as developed by Shaw JW, Johnson JA, Coons SJ. US valuation of the EQ-5D health states: development and testing of the D1 valuation model. Med Care 2005; 43(3): 203-220. The final score has a minimum value of 0 and maximum value of 1 (no problems).

Quality of Life EQ-5D Visual Analog Score

The EQ VAS records the patient's self-rated health on a vertical visual analogue scale. The scale measures how good/bad one's own health is today, in one's own opinion. 0 means the worst imaginable state of health; 100 means the best imaginable state of health.

Full Information

NCT ID

NCT00392054

First Posted

October 23, 2006

Last Updated

January 21, 2020

Sponsor

Population Health Research Institute

Collaborators

Johnson & Johnson

1. Study Identification

Unique Protocol Identification Number

NCT00392054

Brief Title

First Line Radiofrequency Ablation Versus Antiarrhythmic Drugs for Atrial Fibrillation Treatment (The RAAFT Study)

Acronym

RAAFT

Official Title

First Line Radiofrequency Ablation Versus Antiarrhythmic Drugs for Atrial Fibrillation Treatment: A Multi-center Randomized Trial

Study Type

Interventional

2. Study Status

Record Verification Date

January 2020

Overall Recruitment Status

Completed

Study Start Date

August 2006 (undefined)

Primary Completion Date

February 2012 (Actual)

Study Completion Date

February 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Population Health Research Institute

Collaborators

Johnson & Johnson

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The purpose of this study is to determine whether catheter-based pulmonary vein isolation is superior to antiarrhythmic drugs as first line therapy in patients with symptomatic paroxysmal recurrent atrial fibrillation not previously treated with therapeutic doses of antiarrhythmic drugs.

Detailed Description

Atrial fibrillation (AF) is the most common arrhythmia encountered in clinical practice and is estimated to affect 2.2 million people in the United States. AF is a major cause of stroke, adversely affects quality of life, and is associated with increased mortality. Despite advances in antiarrhythmic drug therapy, AF continues to be associated with significant morbidity. Although antiarrhythmic drug therapy is currently considered a first-line option, recent data indicate that more than 35% of Patients will have recurrence of AF despite best antiarrhythmic drug (AAD) therapy, and more than 30% of Patients will discontinue the drugs because of adverse reactions. Furthermore, although recent trials have indicated equivalence of rhythm and rate control strategies in some patient populations, 25-35% of Patients with AF who are rate controlled will continue to have activity limiting symptoms. Newer measures to prevent, treat and potentially cure AF are needed. Seminal work by Haissaguerre and replicated by Chen showed that the majority of AF is initiated by ectopic foci found primarily in the pulmonary veins (PV). Experience with the catheter-based Maze technique led to observations that opened the door to effective and practical catheter-based cures for AF. In response to the difficulties of focal ablation, an alternate strategy has been developed that seeks to electrically isolate the Pulmonary Veins from the atrial tissue. Empirical PV isolation targets all of the PV's without regard to the initiation of ectopic beats. The goal is to create entrance block in the PV. Multipolar circular catheters and basket catheters have been developed that facilitate identification of the electrical connections that are present at the junction of the atrium and the PV, and radiofrequency energy is applied in a circumferential fashion until entrance block is achieved. Relative to focal ablation, circumferential PV isolation is simpler to perform, can be completed without inducing AF, has a shorter procedure time, and has a lower incidence of PV stenosis. Comparison: Patients will have ablation to achieve entrance and/or exit block into all pulmonary veins, compared with patients receiving antiarrhythmic drugs given in accordance with ACC/AHA/ESC 2006 Guidelines for the Management of patients with AF.

6. Conditions and Keywords

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

Atrial Fibrillation

Keywords

Atrial Fibrillation, Paroxysmal, Pulmonary Vein Isolation, Ablation Catheter, Anti-arrhythmic Drug Therapy, First Line Therapy

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

127 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Catheter Ablation

Arm Type

Experimental

Arm Description

Pulmonary vein isolation performed by catheter ablation for the prevention of recurrence of symptomatic atrial fibrillation

Arm Title

Antiarrhythmic Drug Therapy

Arm Type

Active Comparator

Arm Description

Conventional antiarrythmic drug therapy for the prevention of recurrence of symptomatic atrial fibrillation

Intervention Type

Procedure

Intervention Name(s)

Pulmonary Vein Isolation performed by Catheter Ablation

Intervention Description

Ablation will be done to achieve entrance block into all pulmonary veins.

Intervention Type

Drug

Intervention Name(s)

Conventional Antiarrhythmic Drug Therapy

Intervention Description

Anti-Arrhythmic Drugs per ACC/AHA 2006 Guidelines for the Management of Patients with AF

Primary Outcome Measure Information:

Title

Number of Participants With Recurrence of Atrial Tachyarrhythmia

Description

Time Frame

Assessed during 21 month follow-up period

Title

Comparison of Proportion of Patients With an Occurrence of Any of a Cluster of Serious Complications in Either Arm

Description

Time Frame

Assessed during entire 24 month study period

Secondary Outcome Measure Information:

Title

Number of Participants With Recurrence of Symptomatic Atrial Tachyarrhythmia

Description

Time Frame

21 months of follow-up

Title

Number of Participants With Recurrence of Symptomatic Atrial Fibrillation

Description

Time Frame

During 21 month follow-up period

Title

Episodes of ANY Recurrence of Atrial Tachyarrhythmia

Description

Time Frame

During 21 month follow-up period

Title

Number of Participants With Recurrence of Atrial Tachyarrhythmia Obtained Clinically

Description

Time Frame

During 21 month follow-up period

Title

Quality of Life EQ5D Index Score

Description

Time Frame

Measured at 12 months after randomization

Title

Quality of Life EQ-5D Visual Analog Score

Description

Time Frame

Measured At 12 months after randomization

10. Eligibility

Sex

All

Minimum Age & Unit of Time

19 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Age > 18 and ≤ 75 years old. Symptomatic, recurrent paroxysmal AF lasting > 30 seconds (at least 4 episodes within the prior 6 months). At least one episode must be documented by Holter,12-lead ECG, event monitor or rhythm strip. Exclusion Criteria: Documented LVEF <40%. Documented left atrial diameter >5.5cm. Moderate to severe LVH (LV wall thickness >1.5cm). Documented valvular disease, coronary heart disease (defined as the presence of >70% stenosis of coronary arteries or documentation of active myocardial ischemia), post-CABG, postoperative cardiac surgery or peripheral artery disease. Documented AF with electrical cardioversion where full therapeutic antiarrhythmic drug therapy after the cardioversion was prescribed. Untreated hypothyroidism or hyperthyroidism. Patients who are euthyroid on thyroid hormone replacement therapy are acceptable. Contraindication for the use of sotalol, dofetilide and 1C antiarrhythmic drugs(liver enzymes and serum creatinine that are outside the upper normal lab values, e.g. > 3 times ULN with 2 abnormal lab values). Previous left heart ablation procedure, either by surgery or by percutaneous catheter, for atrial fibrillation. Current enrollment in another investigational drug or device study. Presence of any other condition that the investigator feels would be problematic or would restrict or limit the participation of the Patient for the entire study period. Absolute contra-indication to the use of heparin and or warfarin. Increase risk of bleeding, current peptic ulceration, proliferative diabetic retinopathy, history of severe systemic bleeding, or other history of bleeding diathesis or coagulopathy. Severe pulmonary disease e.g. restrictive pulmonary disease, chronic obstructive disease (COPD). Documented intra-atrial thrombus, tumor, or another abnormality which precludes catheter introduction. Previous use of full therapeutic dose of an antiarrhythmic drug, including amiodarone, propafenone, flecainide, sotalol, quinidine. Pacemaker or Implantable Cardioverter Defibrillator. Women with a positive pregnancy test. Evidence of active cardiac or systemic infection. Medical condition limiting expected survival to less than one year.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Carlos A Morillo, MD

Organizational Affiliation

Population Health Research Institute, Hamilton Health Sciences Corporation and McMaster University

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Natale Andrea, MD

Organizational Affiliation

Texas Cardiac Arrhythmia Research Foundation

Official's Role

Principal Investigator

Facility Information:

Facility Name

Texas Cardiac Arrhythmia Foundation

City

Austin

State/Province

Texas

ZIP/Postal Code

78705

Country

United States

Facility Name

Austin Heart

City

Austin

State/Province

Texas

ZIP/Postal Code

78756

Country

United States

Facility Name

Victoria Cardiac Arrhythmia Trials Inc.

City

Victoria

State/Province

British Columbia

ZIP/Postal Code

V8R 4R2

Country

Canada

Facility Name

Hamilton General Hospital

City

Hamilton

State/Province

Ontario

ZIP/Postal Code

L8L 2X2

Country

Canada

Facility Name

London Health Sciences Centre University Hospital

City

London

State/Province

Ontario

ZIP/Postal Code

N6A 5A5

Country

Canada

Facility Name

Southlake Regional Health Centre

City

Newmarket

State/Province

Ontario

ZIP/Postal Code

L3Y 2P9

Country

Canada

Facility Name

Sunnybrook Health Sciences Centre

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M4N 3M5

Country

Canada

Facility Name

Montreal Heart Institute

City

Montreal

State/Province

Quebec

ZIP/Postal Code

H1T 1C8

Country

Canada

Facility Name

McGill University

City

Montreal

State/Province

Quebec

ZIP/Postal Code

H3G 1A4

Country

Canada

Facility Name

Institut Universitaire de Cardiologie et Pneumologie de Québec

City

Quebec

ZIP/Postal Code

G1V 4G5

Country

Canada

Facility Name

Institute for Clinical and Experimental Medicine

City

Prague

State/Province

Prague 4

Country

Czechia

Facility Name

Charles University

City

Prague

Country

Czechia

Facility Name

Abteilung Rhythmologie

City

Bad Krozingen

ZIP/Postal Code

79188

Country

Germany

Facility Name

Asklepios Klinik St. Georg

City

Hamburg

ZIP/Postal Code

79188

Country

Germany

Facility Name

University Hospital Eppendorf

City

Hamburg

ZIP/Postal Code

D-20246

Country

Germany

Facility Name

F. Miulli Hospital

City

Acquaviva delle Fonti

State/Province

Bari

ZIP/Postal Code

70021

Country

Italy

12. IPD Sharing Statement

Citations:

PubMed Identifier

9737513

Citation

Benjamin EJ, Wolf PA, D'Agostino RB, Silbershatz H, Kannel WB, Levy D. Impact of atrial fibrillation on the risk of death: the Framingham Heart Study. Circulation. 1998 Sep 8;98(10):946-52. doi: 10.1161/01.cir.98.10.946.

Results Reference

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PubMed Identifier

16904574

Citation

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PubMed Identifier

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Citation

Haissaguerre M, Jais P, Shah DC, Gencel L, Pradeau V, Garrigues S, Chouairi S, Hocini M, Le Metayer P, Roudaut R, Clementy J. Right and left atrial radiofrequency catheter therapy of paroxysmal atrial fibrillation. J Cardiovasc Electrophysiol. 1996 Dec;7(12):1132-44. doi: 10.1111/j.1540-8167.1996.tb00492.x.

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PubMed Identifier

9725923

Citation

Haissaguerre M, Jais P, Shah DC, Takahashi A, Hocini M, Quiniou G, Garrigue S, Le Mouroux A, Le Metayer P, Clementy J. Spontaneous initiation of atrial fibrillation by ectopic beats originating in the pulmonary veins. N Engl J Med. 1998 Sep 3;339(10):659-66. doi: 10.1056/NEJM199809033391003.

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Citation

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Results Reference

derived

Links:

URL

http://www.phri.ca

Description

Population Health Research Institute - The RAAFT Study - Sponsor and Central Coordination

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First Line Radiofrequency Ablation Versus Antiarrhythmic Drugs for Atrial Fibrillation Treatment (The RAAFT Study)

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