Treatment Of Atrial Fibrillation In Preserved Cardiac Function Heart Failure (TAP-CHF)
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT04160000 |
Recruitment Status :
Not yet recruiting
First Posted : November 12, 2019
Last Update Posted : July 24, 2020
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Atrial Fibrillation Heart Failure Diastolic Heart Failure | Device: Catheter ablation Drug: Rate or Rhythm control antiarrhythmic drugs for atrial fibrillation | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 360 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Intervention Model Description: | This study is a randomized, open label, active-controlled trial with an open-label safety extension, designed to compare a composite clinical outcomes endpoint of cardiovascular hospitalizations and survival among patients randomized to catheter ablation or rate or rhythm control drug therapy. This is an open label two phase study in which patients will be randomized in a 1:1 ratio to receive catheter ablation or rate or rhythm control drug therapy. |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Phase 4, Randomized, Open Label, Multicenter Prospective Comparative Study To Evaluate The Treatment Of Atrial Fibrillation In Preserved Cardiac Function Heart Failure |
Estimated Study Start Date : | October 1, 2020 |
Estimated Primary Completion Date : | March 31, 2022 |
Estimated Study Completion Date : | June 30, 2025 |

Arm | Intervention/treatment |
---|---|
Active Comparator: Catheter Ablation
Patients with atrial fibrillation and heart failure with preserved systolic function will be enrolled after informed consent. They randomly assigned to catheter ablation as one arm. They will undergo a catheter ablation procedure within 14 days of randomization. This procedure will include isolation of all four pulmonary veins in the antrum using catheter delivered radiofrequency current, cryothermal or laser ablation energy with standard FDA approved ablation catheter systems used in atrial fibrillation ablation. Patients will be monitored for a minimum period of 12 months after the catheter ablation intervention.
|
Device: Catheter ablation
Delivery of physical energy from external energy source via percutaneously inserted electrophysiologic catheter to destroy heart tissue in the human atrium and adjoining vasculature
Other Name: Ablation |
Active Comparator: Antiarrhythmic drug therapy
Patients with atrial fibrillation and heart failure with preserved systolic function will be enrolled after informed consent. They randomly assigned to antiarrhythmic drug therapy for Rate or Rhythm control as one arm. They will undergo drug dose titration within 14 days of randomization. This procedure will include isolation of all four pulmonary veins in the antrum using catheter delivered radiofrequency current, cryoballoon or laser balloon ablation with standard FDA approved ablation catheter systems used in atrial fibrillation ablation. Patients will be monitored for a minimum period of 12 months after the catheter ablation intervention.
|
Drug: Rate or Rhythm control antiarrhythmic drugs for atrial fibrillation
Administration of antiarrhythmic drug to achieve either rate control or restoration of sinus rhythm for management of atrial fibrillation
Other Name: Antiarrhythmic Drug |
- Time to Composite of Heart failure hospitalizations and/or Cardiovascular mortality [ Time Frame: From date of randomization until the date of first documented heart failure hospitalization or date of death from cardiovascular causes, whichever came first, assessed up to 12 months ]Time to either first of Heart failure hospitalization and/or mortality due to cardiovascular etiology
- All cause Mortality [ Time Frame: From date of randomization until the date of death from any cause, assessed up to 12 months ]Time to mortality due to any cause
- MACE events [ Time Frame: From date of randomization until the date of first documented major adverse cardiovascular event, assessed up to 12 months ]Time to major adverse cardiovascular event
- Cardiovascular Hospitalization [ Time Frame: From date of randomization until the date of first documented hospitalization due to cardiovascular causes , assessed up to 12 months ]Time to first hospitalization due to cardiovascular causes

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 75 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria: Patient with symptomatic Heart Failure with preserved systolic cardiac function & paroxysmal or persistent atrial fibrillation who meet the following criteria
- Subjects must be willing and able to give written informed consent
- Outpatients ≥ 50 years of age, male or post- menopausal female patients; premenopausal female patients who are on and will maintain continuous birth control therapy during the study.
- Subjects must have documented HFpEF & paroxysmal or persistent AF and satisfy one of the following inclusion criteria a) Consecutive patients with AF, symptomatic heart failure requiring diuretic therapy for at least 30 days prior to study entry b) Hospitalization for HF and/or AF in the past 12 months prior to catheter ablation with documented NT-pro BNP >200pg/ml for patients not in AF or > 600 pg/ml for patients in AF on screening ECG or NYHA class 2, 3 or ambulatory class 4 heart failure documented NT-pro BNP >300pg/ml for patients not in AF or > 900 pg/ml for patients in AF on screening ECG c).Evidence of structural heart disease defined as by at least 1 of the following echocardiography findings (any local measurement made during the screening epoch or within the 6 months prior to screening visit): 1) LA enlargement defined by at least 1 of the following: LA width (diameter) >3.8 cm or LA length >5.0 cm or LA area >20 cm2 or LA volume >55 ml or LA volume index >29 ml/m2 2) LVH defined by septal thickness or posterior wall thickness >1.1 cm d).Left ventricular ejection fraction > 45% using standard imaging techniques at enrollment for study or in prior 6 months e).ECG documented paroxysmal or persistent atrial fibrillation f).Patients are candidates for a clinically indicated catheter ablation procedure, and Rate or Rhythm control antiarrhythmic drug therapy
- Patients should be on one or more standard heart failure drug therapy (ies) for heart failure with preserved cardiac function for at least 30 days
- Written informed consent for the clinically indicated study procedures
- Patients must be candidates for long-term OAC therapy based on clinical practice guidelines for treatment of AF. Guidelines for GFR as established for DOACSs will be applicable to all subjects.
Exclusion Criteria:
- Patients with HFpEF who were not on any drug therapy for HF or have uncontrolled hypertension defined as systolic BP >180 mm Hg at screening or >150 mm Hg on three or more antihypertensive drugs
- Patients with QRS duration of >120 ms and intraventricular conduction defects who are or maybe candidates for or have received ventricular resynchronization therapy
- Recent (<1 month) myocardial infarction or acute coronary syndrome
- Recent (<3 months) coronary revascularization procedures
- Documented LA thrombus on TEE or any LVEF measurement <40%
- Patients who are not candidates for Rate or Rhythm control drug therapy for AF
- Dilated cardiomyopathy due to potentially reversible cause e.g. myocarditis
- Contraindications to anticoagulant therapy or adverse event with prior Warfarin or DOAC therapy
- Creatinine clearance <30ml/min or >95ml/min
- Advanced hepatic disease, pulmonary disease clinically significant congenital heart disease, clinically significant pericardial constriction, hypertrophic cardiomyopathy, infiltrative cardiomyopathy, decompensated valvular heart disease likely to require surgical or percutaneous intervention during the trial
- Recent stroke (<3 months) or thromboembolic event, transient ischemic attack or carotid angioplasty in the prior 3 months
- Recent (<3 months) intracranial or other major bleeding event
- Candidates for heart or any other organ transplantation or left ventricular assist devices, recent (< 3 months) valve or other cardiac surgery
- Patients requiring ACE inhibitor or ARB drug therapy for any reason
- History of hypersensitivity to antiarrhythmic drugs
- Patients with other clinically significant medical condition that precludes study participation
- Patients with life expectancy < 1 year
- Premenopausal female patients, who are not on continuous birth control therapy or are likely to discontinue it at any time during the entire duration of study enrollment.
- Pregnant or nursing lactating mothers or women of childbearing potential who are not on effective contraceptive therapy
- Patients who have been noncompliant with medical regimens or have social or other issues precluding regular follow up, history of alcohol or drug abuse in past 12 months.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04160000
Contact: SANJEEV SAKSENA, MD | 7323029990 ext 7323029990 | cmenj@aol.com | |
Contact: Carine Carvalhiero, BS | 7323029990 ext 7323029990 | eprf@aol.com |
United States, New Jersey | |
Electrophysiology Research Foundation | |
Warren, New Jersey, United States, 07059 | |
United States, Texas | |
TCAI at St. David's Hospital | |
Austin, Texas, United States, 78705 | |
Contact: Andrea Natale, MD dr.natale@gmail.com | |
Contact: Sangamitra Mohanty, MBBS Mitra.Mohanty@stdavidsintl.com |
Study Chair: | Sanjeev Saksena, MD | Electrophysiology Research Foundation | |
Study Director: | Andrea Natale, MD | Electrophysiology Research Foundation |
Responsible Party: | Electrophysiology Research Foundation |
ClinicalTrials.gov Identifier: | NCT04160000 |
Other Study ID Numbers: |
EPRF - 2019 - 11 |
First Posted: | November 12, 2019 Key Record Dates |
Last Update Posted: | July 24, 2020 |
Last Verified: | November 2019 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
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 |
Atrial fibrillation Heart failure Diastolic heart failure Catheter Ablation Antiarrhythmic Drugs |
Heart Failure Atrial Fibrillation Heart Failure, Diastolic Heart Diseases |
Cardiovascular Diseases Arrhythmias, Cardiac Pathologic Processes Anti-Arrhythmia Agents |