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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 : November 21, 2019
Sponsor:
Information provided by (Responsible Party):
Electrophysiology Research Foundation

Brief Summary:
This is a prospective randomized comparative evaluation of catheter ablation and rate or rhythm control drug therapy for safety and efficacy in in patients with atrial fibrillation and one or more HF events with preserved systolic cardiac function. 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 heart failure hospitalizations and cardiovascular mortality among patients randomized to catheter ablation or rate or rhythm control drug therapy.

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

Detailed 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 heart failure hospitalizations and cardiovascular mortality in patients with atrial fibrillation with heart failure with preserved systolic function. The will be 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. The pilot phase will consist to 60 patients .They will be followed for a minimum of 6 months for safety and efficacy. The main trial will enroll 360 patients at 20 centers and they will be followed for a minimum of 12 months. Pilot phase patients will be followed in the main trial. Drug transitions will be performed according to approved drug labeling.

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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 : March 1, 2020
Estimated Primary Completion Date : October 31, 2021
Estimated Study Completion Date : October 31, 2024

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria: Patient with symptomatic Heart Failure with preserved systolic cardiac function & paroxysmal or persistent atrial fibrillation who meet the following criteria

  1. Subjects must be willing and able to give written informed consent
  2. 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.
  3. 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
  4. 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
  5. Written informed consent for the clinically indicated study procedures
  6. 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:

  1. 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
  2. Patients with QRS duration of >120 ms and intraventricular conduction defects who are or maybe candidates for or have received ventricular resynchronization therapy
  3. Recent (<1 month) myocardial infarction or acute coronary syndrome
  4. Recent (<3 months) coronary revascularization procedures
  5. Documented LA thrombus on TEE or any LVEF measurement <40%
  6. Patients who are not candidates for Rate or Rhythm control drug therapy for AF
  7. Dilated cardiomyopathy due to potentially reversible cause e.g. myocarditis
  8. Contraindications to anticoagulant therapy or adverse event with prior Warfarin or DOAC therapy
  9. Creatinine clearance <30ml/min or >95ml/min
  10. 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
  11. Recent stroke (<3 months) or thromboembolic event, transient ischemic attack or carotid angioplasty in the prior 3 months
  12. Recent (<3 months) intracranial or other major bleeding event
  13. Candidates for heart or any other organ transplantation or left ventricular assist devices, recent (< 3 months) valve or other cardiac surgery
  14. Patients requiring ACE inhibitor or ARB drug therapy for any reason
  15. History of hypersensitivity to antiarrhythmic drugs
  16. Patients with other clinically significant medical condition that precludes study participation
  17. Patients with life expectancy < 1 year
  18. 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.
  19. Pregnant or nursing lactating mothers or women of childbearing potential who are not on effective contraceptive therapy
  20. 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.

Information from the National Library of Medicine

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


Contacts
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Contact: SANJEEV SAKSENA, MD 7323029990 ext 7323029990 cmenj@aol.com
Contact: Carine Carvalhiero, BS 7323029990 ext 7323029990 eprf@aol.com

Locations
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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   
Sponsors and Collaborators
Electrophysiology Research Foundation
Investigators
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Study Chair: Sanjeev Saksena, MD Electrophysiology Research Foundation
Study Director: Andrea Natale, MD Electrophysiology Research Foundation
Publications:
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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: November 21, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by Electrophysiology Research Foundation:
Atrial fibrillation
Heart failure
Diastolic heart failure
Catheter Ablation
Antiarrhythmic Drugs
Additional relevant MeSH terms:
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Heart Failure
Atrial Fibrillation
Heart Failure, Diastolic
Heart Diseases
Cardiovascular Diseases
Arrhythmias, Cardiac
Pathologic Processes
Anti-Arrhythmia Agents