Congestive Heart FailurePhase 4CATCH-AFNCT02686749

Catheter Ablation vs. Medical Therapy in Congested Hearts With AF

A Phase 4 study testing Catheter Ablation and FDA approved anti arrhythmic drug in people with Congestive Heart Failure and Left Ventricular Failure, run by The Cleveland Clinic at 6 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Congestive Heart Failure, Left Ventricular Failure, Atrial Fibrillation
What is being tested?: Catheter Ablation and FDA approved anti arrhythmic drug
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 4 participants
Where: 6 sitesUnited States
Study dates: Jun 2016to 1 Oct 2018
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Show all 19Show fewer

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.

Trial locations and contacts

6 sites in 1 country.

City, postcode or hospital

6 sites in 1 country

United States6 sites

Cleveland Clinic Akron General
Akron, Ohio, 44307
Cleveland Clinic
Cleveland, Ohio, 44195
The Ohio State University Wexner Medical Center
Columbus, Ohio, 43210
Hartford Hospital
Hartford, Connecticut, 06102
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
University of Utah
Salt Lake City, Utah, 84132

Other trials in United States

About this study

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

Read the 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.

Conditions: Congestive Heart Failure, Left Ventricular Failure, Atrial Fibrillation
Being tested: Catheter Ablation, FDA approved anti arrhythmic drug
Medical subject headings: Heart Failure, Atrial Fibrillation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Catheter AblationDevice
Also called Pulmonary Vein Isolation
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.
FDA approved anti arrhythmic drugDrug
Anti arrhythmic drug medical treatment will be based on treating physicians discretion following standard clinical guidelines

Study groups in NCT02686749
Study group	Role	What they receive
AF catheter Ablation	Active comparator	Pulmonary Vein Isolation catheter ablation for treatment of AF. AF catheter ablation is an FDA approved treatment for AF Receives: 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. Receives: Drug: FDA approved anti arrhythmic drug

What is being measured

The primary outcome is the main question the study is designed to answer.

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).
Measured: 12 months

Secondary outcomes (5)

Total Number of Cardiovascular Hospitalization
total number of cardiovascular hospitalization measured by hospitalization admissions
Measured: 15 months
Time to Recurrence if AF Lasting Longer Than 30 Seconds
time measured in days to recurrence of AF lasting longer than 30 seconds
Measured: 15 months
Distance Walked in a 6-mile Walk Test
change in distance walked in 6 mile walk test
Measured: 3 months through 15 months
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
Measured: 3 months through 15 months
Change in Ejection Fraction (EF)
Change in Ejection Fraction heart failure measurement (percentage)
Measured: baseline through15 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jun 20161 Oct 2018

First posted19 Feb 2016 (estimated)
Study startJun 2016
Primary completion19 Jul 2018
Study completion1 Oct 2018

Why it stopped: unable to reach enrollment goal

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (5)Papers the sponsor has linked to this study.
Other trials for Congestive Heart FailureStudies of the same condition, open and under way.
More trials run by The Cleveland ClinicThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
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)
Enrolment: 4 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02686749
Sponsor's protocol ID: Bio-858981
Acronym: CATCH-AF
Status last verified: May 2025
First submitted: 5 Feb 2016
Last updated: 5 Jun 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: Yes
Individual data sharing: No

Publications

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.
PubMed 7062992
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.
PubMed 9155607
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.
PubMed 15028358
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.
PubMed 14574035
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.
PubMed 15007003

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 4
The Effects of Ferric Derisomaltose in Patients With Acute Heart Failure and Iron Deficiency on Exercise Capacity and Quality of Life(COREVIVE-HFrEF)
Heart Failure With Reduced Ejection Fraction, Iron Deficiency
Not yet recruitingPhase 2
A Study of Bimagrumab in Participants With HFpEF
Heart Failure, Diastolic, Diastolic Heart Failure
Recruiting
Evaluation of a French Hospital Discharge Therapeutic Education Program by Nurses for Heart Failure Patient (EduSor)
Heart Failure
Active, not recruiting
Assessment of Combined CCM and ICD Device in HFrEF
Heart Failure, Heart Failure With Reduced Ejection Fraction
Not yet recruiting
RELIEVE-HFrEF TRIAL: REducing Lung congestIon Symptoms Using the v-wavE Shunt in adVancEd Heart Failure With Reduced EF
Heart Failure and Reduced Ejection Fraction, Heart Failure Chronic

All Congestive Heart Failure trials

Study at a glance

From the registry record, last updated by the sponsor on 5 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT02686749
Acronym / sponsor ID: CATCH-AF / Bio-858981
Conditions: Congestive Heart Failure, Left Ventricular Failure, Atrial Fibrillation
Phase: Phase 4
Study type: Interventional
Recruitment status: TerminatedReason stopped: unable to reach enrollment goal
Enrolment: 4 participants (actual)
Lead sponsor: The Cleveland ClinicUniversity, hospital or other
Collaborators: Biosense Webster, Inc.
Study start: Jun 2016 (actual)
Primary completion: 19 Jul 2018 (actual)
Study completion: 1 Oct 2018 (actual)
First posted: 19 Feb 2016 (estimated)
Results: Posted 5 Jun 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2
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.

Arm	Type	Receives
AF catheter Ablation	Active comparator	Device: Catheter AblationPulmonary Vein Isolation catheter ablation for treatment of AF. AF catheter ablation is an FDA approved treatment for AF
FDA approved anti arrhythmic drug	Active comparator	Drug: FDA approved anti arrhythmic drugFDA approved anti arrhythmic drug for the treatment of AF will be based on treating physicians' preference in accordance to guidelines.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

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

Key exclusion criteria (19 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Catheter AblationAlso: Pulmonary Vein IsolationDuring 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.	Device	AF catheter Ablation
FDA approved anti arrhythmic drugAnti arrhythmic drug medical treatment will be based on treating physicians discretion following standard clinical guidelines	Drug	FDA approved anti arrhythmic drug

Primary outcome

First Hospitalization for Heart Failure, Recurrence of AF or Direct Current Cardioversion
Time frame: 12 months
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).

5 secondary outcomes

Total Number of Cardiovascular Hospitalization
Time frame: 15 months
Time to Recurrence if AF Lasting Longer Than 30 Seconds
Time frame: 15 months
Distance Walked in a 6-mile Walk Test
Time frame: 3 months through 15 months
Change in the Rand 36-Item Health Survey
Time frame: 3 months through 15 months
Change in Ejection Fraction (EF)
Time frame: baseline through15 months

Results and safety

Results posted to the registry on 5 Jun 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
AF Catheter Ablation	2	0
FDA Approved Anti Arrhythmic Drug	2	0

Primary outcome: First Hospitalization for Heart Failure, Recurrence of AF or Direct Current Cardioversion

Time frame: 12 months

Population analysed: 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.

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: Up to 12 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
AF Catheter Ablation	0 of 2 (0%)	0 of 2 (0%)	0 of 2
FDA Approved Anti Arrhythmic Drug	0 of 2 (0%)	0 of 2 (0%)	0 of 2

Limitations and caveats (from the sponsor): 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.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 7062992Kannel 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.
Background: PubMed 9155607Van 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.
Background: PubMed 15028358Chen 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.
Background: PubMed 14574035Wyse 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.
Background: PubMed 15007003Corley 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.
Individual participant dataSharing planned: No

Related trials for Congestive Heart Failure

RecruitingPhase 4
The Effects of Ferric Derisomaltose in Patients With Acute Heart Failure and Iron Deficiency on Exercise Capacity and Quality of Life(COREVIVE-HFrEF)
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Oussama Wazni, MD principal investigator

The Cleveland Clinic

6 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 5 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 5 Jun 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

First Hospitalization for Heart Failure, Recurrence of AF or Direct Current Cardioversion (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02686749, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2025.