Sponsor:
Electrophysiology Research Foundation
Code:
NCT04160000
Conditions
Atrial Fibrillation
Heart Failure
Diastolic Heart Failure
Eligibility Criteria
Sex: All
Age: 18 - 70+
Healthy Volunteers: Not accepted
Interventions
Catheter ablation
Rate or Rhythm control antiarrhythmic drugs for atrial fibrillation
Insertion of CardioMems Hemodynamic monitor
Empiric heart failure drug therapy
Brief summary:
Conditions
Atrial Fibrillation
Heart Failure
Diastolic Heart Failure
Study ID
NCT04160000
Start date
Jul 26, 2020
Status verified date
May, 2024
Completion date
Jun 30, 2025
Anticipated
Primary completion date
Dec 31, 2024
Anticipated
Eligibility Criteria
Sex: All
Age: 18 - 70+
Healthy Volunteers: Not accepted
Enrollment
360 participants
Anticipated
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary purpose
Treatment
Arms
active comparator: Phase 1 Catheter Ablation
active comparator: Phase 1 Antiarrhythmic drug therapy
active comparator: Phase 2 Guided Heart Failure Therapy
active comparator: Phase 2 Empiric Heart Failure Therapy
Interventions
Catheter ablation
Rate or Rhythm control antiarrhythmic drugs for atrial fibrillation
Insertion of CardioMems Hemodynamic monitor
Empiric heart failure drug therapy
Primary outcome measure
Central contacts
Locations
Northern Arizona Health Care
Recruiting
Flagstaff, Arizona, United States, 86001
Contacts
Principal Investigator:
Rangadham Nagarakanti
St. Bernards Heart and Vascular Center
Recruiting
Jonesboro, Arkansas, United States, 72401
Contacts
Devi G Nair, MD
dr.devignair@gmail.comSouth Denver Cardiology
Recruiting
Littleton, Colorado, United States, 80120
Contacts
Sri Sundaram, MD
sris@southdenver.comMary Soltau, MSN
msoltau@southdenver.comKansas City Heart Rhythm Institute
Recruiting
Overland, Missouri, United States, 66211
Contacts
Dhananjaya R Lakkireddy, MD
dlakkireddy@gmail.comJennifer Bush, MSN
jennifer.bush2@hcahealthcare.comElectrophysiology Research Foundation
Recruiting
Warren, New Jersey, United States, 07059
Contacts
Carine Carvalheiro
732-302-9990Principal Investigator:
Sanjeev Saksena, MD
Hospital of the University of Pennsylvania
Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contacts
Mathew D Hyman, MD
matthew.hyman@pennmedicine.upenn.eduMary Gnap
mary.gnap@pennmedicine.upenn.eduTCAI at St. David's Hospital
Recruiting
Austin, Texas, United States, 78705
Contacts
Andrea Natale, MD
dr.natale@gmail.comSangamitra Mohanty, MBBS
Mitra.Mohanty@stdavidsintl.comSponsor
Electrophysiology Research Foundation
Last update posted
May 23, 2024
Last verified
May, 2024
Keywords
Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Electrophysiology Research Foundation on 2024-05-23.