Ignite Creation Date:
2024-05-06 @ 1:56 PM
Last Modification Date:
2024-10-26 @ 1:22 PM
Study NCT ID:
NCT04160000
Status:
RECRUITING
Last Update Posted:
2024-05-23
First Post:
2019-11-06
Brief Title:
Treatment Of Atrial Fibrillation In Preserved Cardiac Function Heart Failure
Sponsor:
Electrophysiology Research Foundation
Organization:
Electrophysiology Research Foundation
Study Overview
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
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TAP-CHF
Brief Summary:
Heart failure HF with preserved left ventricular function pEF is difficult clinical syndrome to treat effectively with few evidence based therapies Atrial fibrillation AF is now an important co-morbidity being observed in 43 of patients with HFpEF Rhythm control has not been studied in this population Catheter ablation and antiarrhythmic drugs are rhythm control therapies that have been used for treatment of AF without HF or HF with reduced systolic function but have not been widely applied in HFpEF No controlled comparative evaluation has been performed in HFpEF
The introduction of wireless pulmonary artery hemodynamic monitoring has permitted optimization of HF therapy in patients with chronic HF with reduced and preserved EF Reduction in HF hospitalizations has been observed in post hoc analyses of HFpEF patients but has not been systematically applied in AF patients with HFpEF
In this study we propose to study both rhythm control and optimized HF therapeutic approaches in an AF with HFpEF study population in a pilot study using a sequential two phase randomized controlled clinical trial design
The introduction of wireless pulmonary artery hemodynamic monitoring has permitted optimization of HF therapy in patients with chronic HF with reduced and preserved EF Reduction in HF hospitalizations has been observed in post hoc analyses of HFpEF patients but has not been systematically applied in AF patients with HFpEF
In this study we propose to study both rhythm control and optimized HF therapeutic approaches in an AF with HFpEF study population in a pilot study using a sequential two phase randomized controlled clinical trial design
Detailed Description:
This is a prospective pilot study utilizing a randomized comparative sequential evaluation of these two therapeutic approaches in two consecutive phases
Phase 1 will examine an initial catheter ablation strategy versus an initial antiarrhythmic drug AAD therapy strategy for safety and efficacy in patients with atrial fibrillation with preserved systolic cardiac function heart failure hospitalization in the past year or one or more documented HF events
Phase 2 will examine optimized rhythm control therapy with and without wireless pulmonary artery pressure hemodynamic monitoring for HF therapy optimization in the same patients as in Phase 1 with documented atrial fibrillation with preserved systolic cardiac function prior HF hospitalization and class III heart failure
This is an open label two phase study in which patients will be randomized in a 11 ratio to either ablation or AAD with a pilot phase 1 that will consist to 100 patients enrolled at 10 centers They will be followed for a minimum of 6 months after a three month blanking period for event rates of the primary endpoint as well as safety and efficacy Phase 2 will randomize patients completing Phase 1 to hemodynamic monitoring with a wireless pulmonary artery sensor insertion and guided HF therapy or empiric standard of care HF therapy They will be followed for a minimum of 6 months after a three month blanking period for optimization of rhythm and HF therapies
This study is a sequential randomized open label active-controlled trial designed to compare a composite clinical outcomes endpoint of heart failure hospitalization andor cardiovascular mortality among these patients randomized to each of these treatment strategies This endpoint will be employed in both pilot trial phases to assess event rates as well as safety endpoints This data will form the basis of a larger pivotal trial
Phase 1 will examine an initial catheter ablation strategy versus an initial antiarrhythmic drug AAD therapy strategy for safety and efficacy in patients with atrial fibrillation with preserved systolic cardiac function heart failure hospitalization in the past year or one or more documented HF events
Phase 2 will examine optimized rhythm control therapy with and without wireless pulmonary artery pressure hemodynamic monitoring for HF therapy optimization in the same patients as in Phase 1 with documented atrial fibrillation with preserved systolic cardiac function prior HF hospitalization and class III heart failure
This is an open label two phase study in which patients will be randomized in a 11 ratio to either ablation or AAD with a pilot phase 1 that will consist to 100 patients enrolled at 10 centers They will be followed for a minimum of 6 months after a three month blanking period for event rates of the primary endpoint as well as safety and efficacy Phase 2 will randomize patients completing Phase 1 to hemodynamic monitoring with a wireless pulmonary artery sensor insertion and guided HF therapy or empiric standard of care HF therapy They will be followed for a minimum of 6 months after a three month blanking period for optimization of rhythm and HF therapies
This study is a sequential randomized open label active-controlled trial designed to compare a composite clinical outcomes endpoint of heart failure hospitalization andor cardiovascular mortality among these patients randomized to each of these treatment strategies This endpoint will be employed in both pilot trial phases to assess event rates as well as safety endpoints This data will form the basis of a larger pivotal trial
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None