Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Radiofrequency (RF) Ablation for Atrial Fibrillation (AF) in Patients With Heart Failure With Preserved Ejection Fraction (AF-HFpEF)

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: NCT04327596
Recruitment Status : Recruiting
First Posted : March 31, 2020
Last Update Posted : February 4, 2021
Sponsor:
Collaborator:
Biosense Webster, Inc.
Information provided by (Responsible Party):
Mehmet Aktas, University of Rochester

Brief Summary:
The purpose of this study is to determine if patients who receive an early radiofrequency ablation will have fewer hospitalizations, unplanned office visits, and emergency room visits than those patients treated with medical therapy alone.

Condition or disease Intervention/treatment Phase
Heart Failure With Preserved Ejection Fraction Procedure: RF ablation of AF using CARTO 3 and a Thermocool ST SF ablation catheter Not Applicable

Detailed Description:
In this study, subjects with HFpEF and new onset paroxysmal or persistent AF (diagnosed in the past 6 months) will be randomized in a 1:1 ratio to either intervention or medical therapy alone. Twenty subjects will be enrolled to each group for a total of 40 subjects across all enrolling sites. Subjects randomized to the intervention Group will undergo early RF ablation of AF using CARTO 3 and a Thermocool ST SF ablation catheter. The medical therapy alone cohort will receive management of AF consisting of either rate or rhythm control. All patients will be implanted with an implantable cardiac monitor (ICM) as standard of care for AF management in heart failure except for those who already have in place an existing cardiac implantable electronic device (CIED) such as pacemaker, ICM, or implantable cardiac defibrillator (ICD). The ICM procedure will occur within 2 calendar months of randomization for both study groups (intervention or control). For the intervention arm, the CIED procedure will occur prior to or at the time of the AF ablation procedure. Subjects will be followed for 1 year with in-clinic visits occurring at 3, 6, and 12 months.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Intervention Model Description: Subjects will undergo early RF ablation of AF using CARTO 3 and a Thermocool ST SF ablation catheter.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomized Clinical Trial of Radiofrequency Ablation for Atrial Fibrillation in Patients With Heart Failure With Preserved Ejection Fraction for Reduced Healthcare Utilization
Actual Study Start Date : January 25, 2021
Estimated Primary Completion Date : October 2022
Estimated Study Completion Date : November 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: Conventional Treatment
Subjects will receive management of AF consisting of either rate or rhythm control.
Active Comparator: AF Ablation
Subjects will undergo early RF ablation of AF using CARTO 3 and a Thermocool ST SF ablation catheter
Procedure: RF ablation of AF using CARTO 3 and a Thermocool ST SF ablation catheter
Ablation of AF is standard of care in the management of patients with paroxysmal or persistent AF. The most common triggers initiating AF arise from pulmonary veins (PV) and successful electrical isolation of PV's can significantly reduce the burden of AF. Therefore, the main objective in patients undergoing ablation of AF is to achieve PV isolation.




Primary Outcome Measures :
  1. Rate of healthcare utilization. [ Time Frame: up to 12 months ]
    Number of unplanned office visits, hospitalizations, and emergency room visits.


Secondary Outcome Measures :
  1. Burden of Atrial Fibrillation (AF) [ Time Frame: Between baseline and 12 months ]
    Percentage of time spent in AF (i.e. amount of time spent in AF divided by the total amount of CIED monitoring time).

  2. Change in quality of life measures in Patient-Reported Outcomes Measurement Information System (PROMIS). [ Time Frame: Between baseline and 6 months ]
    Consists of 24 questions with a scale of 1-5 with 1 being the worst

  3. 6-minute Walk Test [ Time Frame: 6 Months ]
    Mean changes in functional status

  4. Quality of life measures using the Kansas City Cardiomyopathy Questionnaire (KCCQ) [ Time Frame: Between baseline and 6 months ]
    Consists of 8 questions with a scale of 1-5 with 1 being the worst



Information from the National Library of Medicine

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.


Layout table for eligibility information
Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age ≥ 50 years at date of consent.
  • LVEF >50% as determined on imaging study measured in the last 6 calendar months prior to or on consent date.
  • Hospitalized for HF within the past 12 calendar months prior to consent date.
  • Stabilized patients defined as being off all IV therapies for at least 24 hours prior to consent date.
  • Paroxysmal AF diagnosed within the past 6 calendar months or early persistent AF, defined as an AF episode lasting greater than 7 days but less than 6 calendar months prior to consent date.
  • Indicated for oral anticoagulation according to current guidelines (CHA2DS2-VASc ≥ 2 in men or ≥ 3 in women at the time of consent)*
  • Patient with CIED in situ at time of consent or scheduled to undergo ICM implant for AF management within 2 calendar months of randomization.

Exclusion Criteria:

  • Previous catheter or surgical ablation of AF any time in the past.
  • Long-standing persistent AF (>1-year prior to consent date) or permanent AF.
  • Chronic pulmonary disease requiring home oxygen or oral/IV steroid therapy in the past 12 calendar months prior to consent date.
  • Active infection at time of consent but may be re-considered for enrollment later after effective treatment.
  • Left atrial size >50 mm as measured by echo in the past 6 calendar months prior to consent date.
  • Untreated obstructive sleep apnea any time in past.
  • Myocardial infarction in past 3 calendar months prior to consent date.
  • Coronary artery bypass graft (CABG) surgery in past 3 calendar months prior to consent date.
  • Stroke in past 3 calendar months prior to consent date.
  • Intra-cardiac thrombus precluding ability to undergo AF ablation at time of consent but may be re-considered for enrollment later after effective treatment.
  • Infiltrative cardiomyopathy (sarcoid, amyloid) any time in past.
  • Active myocarditis at time of consent but may be re-considered for enrollment later after effective treatment.
  • Hypertrophic cardiomyopathy at any time in past.
  • Known pericardial constriction.
  • Uncontrolled hypertension (SBP > 160 mmHg) at time of consent but may be re- considered for enrollment later after effective treatment.
  • Untreated hypothyroidism or hyperthyroidism but may be re-considered for enrollment later after effective treatment.
  • Pregnancy or nursing.
  • Valvular AF or presence of a prosthetic valve.
  • Undergoing dialysis or have advanced renal dysfunction (eGFR <30 ml/min/m2) defined as 3 times the upper limits of AST or ALT during the past 6 calendar months.
  • Contraindication to anticoagulation.
  • Metabolic derangements (e.g. renal/hepatic failure, electrolyte disturbance, etc.), prohibiting study (EP) study and ablation.
  • Cognitive impairment.
  • Life expectancy < 1 year following consent date.
  • Unwilling to comply with all study protocol-required testing.
  • Unwilling or unable to give informed consent.

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): NCT04327596


Contacts
Layout table for location contacts
Contact: Kathy Honsinger 585-273-1899 kathy.honsinger@heart.rochester.edu

Locations
Layout table for location information
United States, New York
Rochester Regional Health Not yet recruiting
Rochester, New York, United States, 14621
Contact: Megan Littleton, RN    585-922-3635    megan.littleton@rochesterregional.org   
Contact: Tia Albro, NP    585-922-3635    tia.albro@rochesterregional.org   
Principal Investigator: Mohan Rao, MD         
University of Rochester Medical Center Recruiting
Rochester, New York, United States, 14642
Contact: Laura Wing, RN    585-273-4128    laura_wing@urmc.rochester.edu   
Contact: Hannah Kopin, MPH    585-273-5247    hannah_kopin@urmc.rochester.edu   
Principal Investigator: Mehmet K Aktas, MD         
Sponsors and Collaborators
University of Rochester
Biosense Webster, Inc.
Investigators
Layout table for investigator information
Principal Investigator: Mehmet K Aktas, MD University of Rochester
Publications:
Benjamin EJ, Virani SS, Callaway CW, Chamberlain AM, Chang AR, Cheng S, Chiuve SE, Cushman M, Delling FN, Deo R, de Ferranti SD, Ferguson JF, Fornage M, Gillespie C, Isasi CR, Jiménez MC, Jordan LC, Judd SE, Lackland D, Lichtman JH, Lisabeth L, Liu S, Longenecker CT, Lutsey PL, Mackey JS, Matchar DB, Matsushita K, Mussolino ME, Nasir K, O'Flaherty M, Palaniappan LP, Pandey A, Pandey DK, Reeves MJ, Ritchey MD, Rodriguez CJ, Roth GA, Rosamond WD, Sampson UKA, Satou GM, Shah SH, Spartano NL, Tirschwell DL, Tsao CW, Voeks JH, Willey JZ, Wilkins JT, Wu JH, Alger HM, Wong SS, Muntner P; American Heart Association Council on Epidemiology and Prevention Statistics Committee and Stroke Statistics Subcommittee. Heart Disease and Stroke Statistics-2018 Update: A Report From the American Heart Association. Circulation. 2018 Mar 20;137(12):e67-e492. doi: 10.1161/CIR.0000000000000558. Epub 2018 Jan 31. Review. Erratum in: Circulation. 2018 Mar 20;137(12 ):e493.

Layout table for additonal information
Responsible Party: Mehmet Aktas, Professor, University of Rochester
ClinicalTrials.gov Identifier: NCT04327596    
Other Study ID Numbers: 00004367
First Posted: March 31, 2020    Key Record Dates
Last Update Posted: February 4, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Heart Failure
Atrial Fibrillation
Heart Diseases
Cardiovascular Diseases
Arrhythmias, Cardiac
Pathologic Processes