Catheter Ablation vs. Medical Therapy in Congested Hearts With AF

NCT02686749 | Terminated Phase 4 Results FDA Drug FDA Device

• 1 other identifier: Bio-858981
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 6

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.

Conditions

Congestive Heart Failure; Left Ventricular Failure; Atrial Fibrillation

Outcome Measures

Primary Outcomes (1)

• 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).

  12 months

Secondary Outcomes (5)

• Total Number of Cardiovascular Hospitalization

  15 months

• Time to Recurrence if AF Lasting Longer Than 30 Seconds

  15 months

• Distance Walked in a 6-mile Walk Test

  3 months through 15 months

• Change in the Rand 36-Item Health Survey

  3 months through 15 months

• Change in Ejection Fraction (EF)

  baseline through15 months

Study Arms (2)

AF catheter Ablation

ACTIVE COMPARATOR

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

Device: Catheter Ablation

FDA approved anti arrhythmic drug

ACTIVE COMPARATOR

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

Drug: FDA approved anti arrhythmic drug

Interventions

Catheter Ablation DEVICE

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.

Also known as: Pulmonary Vein Isolation

AF catheter Ablation

FDA approved anti arrhythmic drug DRUG

Anti arrhythmic drug medical treatment will be based on treating physicians discretion following standard clinical guidelines

FDA approved anti arrhythmic drug

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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)
• 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.

Sponsors & Collaborators

• The Cleveland Clinic: lead
• Biosense Webster, Inc.: collaborator

Study Sites (6)

Hartford Hospital

Hartford, Connecticut, 06102, United States

Location

Cleveland Clinic Akron General

Akron, Ohio, 44307, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

The Ohio State University Wexner Medical Center

Columbus, Ohio, 43210, United States

Location

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

University of Utah

Salt Lake City, Utah, 84132, United States

Location

Related Publications (5)

• 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.

  PMID: 7062992 BACKGROUND

• 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.

  PMID: 9155607 BACKGROUND

• 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.

  PMID: 15028358 BACKGROUND

• 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.

  PMID: 14574035 BACKGROUND

• 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.

  PMID: 15007003 BACKGROUND

MeSH Terms

Conditions

Heart Failure; Atrial Fibrillation

Interventions

Catheter Ablation

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Radiofrequency Ablation; Radiofrequency Therapy; Therapeutics; Ablation Techniques; Surgical Procedures, Operative

Limitations and Caveats

Trial terminated due to poor enrollment. No subjects completed study. Did not reach the target number of subjects needed to achieve target power and was insufficient to produce statistically reliable results.

Results Point of Contact

• Title: Oussama Wazni, MD
• Organization: Cleveland Clinic

waznio@ccf.org

216-444-2131

Study Officials

• Oussama Wazni, MD

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Study randomizes subjects to already FDA approved treatment modalities. Approved anti-arrhythmic medications or AF ablation. There are no investigational drug or devices used.

Study Record Dates

• First Submitted: February 5, 2016
• First Posted: February 19, 2016
• Study Start: June 1, 2016
• Primary Completion: July 19, 2018
• Study Completion: October 1, 2018
• Last Updated: June 5, 2025
• Results First Posted: June 5, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (6)