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Catheter Ablation vs. Medical Therapy in Congested Hearts With AF (CATCH-AF)

Primary Purpose

Congestive Heart Failure, Left Ventricular Failure, Atrial Fibrillation

Status
Terminated
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Catheter Ablation
FDA approved anti arrhythmic drug
Sponsored by
Oussama Wazni
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Congestive Heart Failure

Eligibility Criteria

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

Inclusion Criteria:

  • must be 18 years of age or older
  • Provide signed written Informed Consent
  • symptomatic AF documented by EKG or heart rhythm monitoring within 12 months
  • patients should be on optimal medical therapy for heart failure for 3 months prior to randomization. Adjustments to medications within this 3 month period are permitted.
  • chronically impaired LV function defined as EF between 20%-45% within last 3 months
  • all patients should be on an optimal therapy for impaired LV function
  • ability to complete 6 minute walk test
  • eligible for catheter ablation and anti-arrhythmic drugs

Exclusion Criteria:

  • women of childbearing potential unless post- menopausal or surgically sterile
  • patients hospitalized for heart failure within the 3 months prior to randomization
  • reversible causes of AF such as pericarditis, thyroid disorders, acute alcohol intoxication, recent major surgical procedures or trauma
  • recent reversible LV impairment that may be attributed to AF with rapid ventricular response and may improve with introduction of rate control
  • valvular heart disease requiring surgical intervention
  • Coronary Artery Disease (CAD) requiring surgical or percutaneous intervention
  • early post-operative AF (within 3 months of surgery)
  • previous MAZE or left atrial instrumentation (including ablation and left atrial appendage exclusion)
  • history of Atrioventricular Node (AVN) ablation
  • hypertrophic cardiomyopathy
  • prolonged QT interval
  • liver failure
  • renal failure requiring dialysis
  • social factors that would preclude follow up or make compliance difficult- history of drug, alcohol or substance abuse
  • contraindications to the use of AADs and/or anticoagulation therapy
  • Currently enrolled in, or discontinued within the last 30 days from a clinical trial involving an investigational product or non-approved use of a drug or device or concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study.
  • severe pulmonary disease
  • documented intra-atrial thrombus, tumor, or structural abnormality which precludes catheter introduction
  • unwilling to comply with protocol requirements or deemed by the investigator to be unfit for the study.

Sites / Locations

  • Hartford Hospital
  • Cleveland Clinic Akron General
  • Cleveland Clinic
  • The Ohio State University Wexner Medical Center
  • Hospital of the University of Pennsylvania
  • University of Utah

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

AF catheter Ablation

FDA approved anti arrhythmic drug

Arm Description

Pulmonary Vein Isolation catheter ablation for treatment of AF. AF catheter ablation is an FDA approved treatment for AF

FDA approved anti arrhythmic drug for the treatment of AF will be based on treating physicians' preference in accordance to guidelines.

Outcomes

Primary Outcome Measures

First hospitalization for heart failure, recurrence of AF or Direct Current cardioversion
Time measured in days to first hospitalization for heart failure, recurrence of AF or Direct Current cardioversion after the treatment period (first 3 months post enrollment or post procedure during which repeat ablation can be performed and titration of AADs can be performed).

Secondary Outcome Measures

Total number of cardiovascular hospitalization
total number of cardiovascular hospitalization measured by hospitalization admissions
Time to recurrence if AF lasting longer than 30 seconds
time measured in days to recurrence of AF lasting longer than 30 seconds
Distance walked in a 6-mile walk test
change in distance walked in 6 mile walk test
Change in the Rand 36-Item Health Survey
change in the Rand 36-Item Health Survey reflective of change in patient's quality of life
Change in Ejection Fraction (EF)
Change in Ejection Fraction heart failure measurement (percentage)

Full Information

First Posted
February 5, 2016
Last Updated
October 23, 2018
Sponsor
Oussama Wazni
Collaborators
Biosense Webster, Inc., The Cleveland Clinic
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1. Study Identification

Unique Protocol Identification Number
NCT02686749
Brief Title
Catheter Ablation vs. Medical Therapy in Congested Hearts With AF
Acronym
CATCH-AF
Official Title
Catheter Ablation vs. Medical Therapy in Congested Hearts With AF (CATCH-AF in Patients With Impaired LV Function): An Early Ablation Strategy Study Impact on Health Care Utilization
Study Type
Interventional

2. Study Status

Record Verification Date
October 2018
Overall Recruitment Status
Terminated
Why Stopped
lack of enrollment
Study Start Date
June 2016 (undefined)
Primary Completion Date
July 19, 2018 (Actual)
Study Completion Date
October 1, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Oussama Wazni
Collaborators
Biosense Webster, Inc., The Cleveland Clinic

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This study is a multi-center, randomized, unblinded, clinical trial. The objective is to determine if catheter-based atrial fibrillation (AF) ablation is superior to medical treatment in patients with impaired left ventricular (LV) function who have been diagnosed with symptomatic AF within the past 12 months.
Detailed Description
The purpose of the trial is to compare two different approved treatments for recently diagnosed AF: anti-arrhythmic medications and AF ablation. The study will be conducted to determine if one treatment is more effective than the other for patients with AF and heart failure. About 220 subjects with newly diagnosed AF from hospitals in the United States will take part in this study. Subjects will be randomized in a 1:1 fashion to either AF catheter ablation or anti-arrhythmic medication for treatment of AF. Both therapies are considered Standard of Care.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Congestive Heart Failure, Left Ventricular Failure, Atrial Fibrillation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
Study randomizes subjects to already FDA approved treatment modalities. Approved anti-arrhythmic medications or AF ablation. There are no investigational drug or devices used.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
220 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
AF catheter Ablation
Arm Type
Active Comparator
Arm Description
Pulmonary Vein Isolation catheter ablation for treatment of AF. AF catheter ablation is an FDA approved treatment for AF
Arm Title
FDA approved anti arrhythmic drug
Arm Type
Active Comparator
Arm Description
FDA approved anti arrhythmic drug for the treatment of AF will be based on treating physicians' preference in accordance to guidelines.
Intervention Type
Device
Intervention Name(s)
Catheter Ablation
Other Intervention Name(s)
Pulmonary Vein Isolation
Intervention Description
During ablation, a doctor inserts a catheter through blood vessels into the heart. The doctor looks at the electrical activity of the heart. The catheter is used to determine which areas of the heart are causing AF. After the area is identified, the doctor uses a special machine delivers energy through the catheter to tiny areas of the heart muscle that is causing AF. This energy causes a scar in the tissue which "disconnects" the pathway of the AF.
Intervention Type
Drug
Intervention Name(s)
FDA approved anti arrhythmic drug
Intervention Description
Anti arrhythmic drug medical treatment will be based on treating physicians discretion following standard clinical guidelines
Primary Outcome Measure Information:
Title
First hospitalization for heart failure, recurrence of AF or Direct Current cardioversion
Description
Time measured in days to first hospitalization for heart failure, recurrence of AF or Direct Current cardioversion after the treatment period (first 3 months post enrollment or post procedure during which repeat ablation can be performed and titration of AADs can be performed).
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Total number of cardiovascular hospitalization
Description
total number of cardiovascular hospitalization measured by hospitalization admissions
Time Frame
15 months
Title
Time to recurrence if AF lasting longer than 30 seconds
Description
time measured in days to recurrence of AF lasting longer than 30 seconds
Time Frame
15 months
Title
Distance walked in a 6-mile walk test
Description
change in distance walked in 6 mile walk test
Time Frame
3 months through 15 months
Title
Change in the Rand 36-Item Health Survey
Description
change in the Rand 36-Item Health Survey reflective of change in patient's quality of life
Time Frame
3 months through 15 months
Title
Change in Ejection Fraction (EF)
Description
Change in Ejection Fraction heart failure measurement (percentage)
Time Frame
baseline through15 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: must be 18 years of age or older Provide signed written Informed Consent symptomatic AF documented by EKG or heart rhythm monitoring within 12 months patients should be on optimal medical therapy for heart failure for 3 months prior to randomization. Adjustments to medications within this 3 month period are permitted. chronically impaired LV function defined as EF between 20%-45% within last 3 months all patients should be on an optimal therapy for impaired LV function ability to complete 6 minute walk test eligible for catheter ablation and anti-arrhythmic drugs Exclusion Criteria: women of childbearing potential unless post- menopausal or surgically sterile patients hospitalized for heart failure within the 3 months prior to randomization reversible causes of AF such as pericarditis, thyroid disorders, acute alcohol intoxication, recent major surgical procedures or trauma recent reversible LV impairment that may be attributed to AF with rapid ventricular response and may improve with introduction of rate control valvular heart disease requiring surgical intervention Coronary Artery Disease (CAD) requiring surgical or percutaneous intervention early post-operative AF (within 3 months of surgery) previous MAZE or left atrial instrumentation (including ablation and left atrial appendage exclusion) history of Atrioventricular Node (AVN) ablation hypertrophic cardiomyopathy prolonged QT interval liver failure renal failure requiring dialysis social factors that would preclude follow up or make compliance difficult- history of drug, alcohol or substance abuse contraindications to the use of AADs and/or anticoagulation therapy Currently enrolled in, or discontinued within the last 30 days from a clinical trial involving an investigational product or non-approved use of a drug or device or concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study. severe pulmonary disease documented intra-atrial thrombus, tumor, or structural abnormality which precludes catheter introduction unwilling to comply with protocol requirements or deemed by the investigator to be unfit for the study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Oussama Wazni, MD
Organizational Affiliation
The Cleveland Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hartford Hospital
City
Hartford
State/Province
Connecticut
ZIP/Postal Code
06102
Country
United States
Facility Name
Cleveland Clinic Akron General
City
Akron
State/Province
Ohio
ZIP/Postal Code
44307
Country
United States
Facility Name
Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
The Ohio State University Wexner Medical Center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
Hospital of the University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
University of Utah
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84132
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
7062992
Citation
Kannel WB, Abbott RD, Savage DD, McNamara PM. Epidemiologic features of chronic atrial fibrillation: the Framingham study. N Engl J Med. 1982 Apr 29;306(17):1018-22. doi: 10.1056/NEJM198204293061703.
Results Reference
background
PubMed Identifier
9155607
Citation
Van den Berg MP, Tuinenburg AE, Crijns HJ, Van Gelder IC, Gosselink AT, Lie KI. Heart failure and atrial fibrillation: current concepts and controversies. Heart. 1997 Apr;77(4):309-13. doi: 10.1136/hrt.77.4.309.
Results Reference
background
PubMed Identifier
15028358
Citation
Chen MS, Marrouche NF, Khaykin Y, Gillinov AM, Wazni O, Martin DO, Rossillo A, Verma A, Cummings J, Erciyes D, Saad E, Bhargava M, Bash D, Schweikert R, Burkhardt D, Williams-Andrews M, Perez-Lugones A, Abdul-Karim A, Saliba W, Natale A. Pulmonary vein isolation for the treatment of atrial fibrillation in patients with impaired systolic function. J Am Coll Cardiol. 2004 Mar 17;43(6):1004-9. doi: 10.1016/j.jacc.2003.09.056.
Results Reference
background
PubMed Identifier
14574035
Citation
Wyse DG. Some recent randomized clinical trials in the management of atrial fibrillation. J Interv Card Electrophysiol. 2003 Oct;9(2):223-8. doi: 10.1023/a:1026292609252.
Results Reference
background
PubMed Identifier
15007003
Citation
Corley SD, Epstein AE, DiMarco JP, Domanski MJ, Geller N, Greene HL, Josephson RA, Kellen JC, Klein RC, Krahn AD, Mickel M, Mitchell LB, Nelson JD, Rosenberg Y, Schron E, Shemanski L, Waldo AL, Wyse DG; AFFIRM Investigators. Relationships between sinus rhythm, treatment, and survival in the Atrial Fibrillation Follow-Up Investigation of Rhythm Management (AFFIRM) Study. Circulation. 2004 Mar 30;109(12):1509-13. doi: 10.1161/01.CIR.0000121736.16643.11. Epub 2004 Mar 8.
Results Reference
background

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Catheter Ablation vs. Medical Therapy in Congested Hearts With AF

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