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

NCT04327596 | Terminated DMC

• 1 other identifier: 00004367
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 2

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.

Conditions

Heart Failure With Preserved Ejection Fraction

Outcome Measures

Primary Outcomes (1)

• Rate of healthcare utilization.

  Number of unplanned office visits, hospitalizations, and emergency room visits.

  up to 12 months

Secondary Outcomes (4)

• Burden of Atrial Fibrillation (AF)

  Between baseline and 12 months

• Change in quality of life measures in Patient-Reported Outcomes Measurement Information System (PROMIS).

  Between baseline and 6 months

• 6-minute Walk Test

  6 Months

• Quality of life measures using the Kansas City Cardiomyopathy Questionnaire (KCCQ)

  Between baseline and 6 months

Study Arms (2)

Conventional Treatment

NO INTERVENTION

Subjects will receive management of AF consisting of either rate or rhythm control.

AF Ablation

ACTIVE COMPARATOR

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

Interventions

RF ablation of AF using CARTO 3 and a Thermocool ST SF ablation catheter PROCEDURE

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.

AF Ablation

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Rochester: lead
• Biosense Webster, Inc.: collaborator

Study Sites (2)

Rochester Regional Health

Rochester, New York, 14621, United States

Location

University of Rochester Medical Center

Rochester, New York, 14642, United States

Location

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Study Officials

• Mehmet K Aktas, MD

  University of Rochester

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Subjects will undergo early RF ablation of AF using CARTO 3 and a Thermocool ST SF ablation catheter.

Study Record Dates

• First Submitted: March 27, 2020
• First Posted: March 31, 2020
• Study Start: January 25, 2021
• Primary Completion: September 21, 2021
• Study Completion: September 21, 2021
• Last Updated: February 23, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)