The company will recruit up to 100 patients at 10 US sites in the multicentre prospective comparative study
Healthcare firm Abbott has launched a new trial to improve treatment options for patients suffering from both atrial fibrillation (AFib) and heart failure.
Claimed to be the first-of-its-kind trial, the new TAP-CHF trial (evaluating the treatment of atrial fibrillation in preserved cardiac function heart failure) has been designed to find improved management options for patients with AFib and heart failure with preserved ejection fraction (HFpEF).
Abbott’s heart failure business chief medical officer Dr Philip Adamson said: “Cardiovascular patients often have more than one heart condition. We believe that we can best help those patients live longer and better lives by providing their doctors improved therapy approaches that address the entirety of their heart disease.
“Trials that look at complex heart conditions together promise to offer new insights and will make a tremendous difference in the outcomes of our patients now and into the future.”
By evaluating patients in two phases, the TAP-CHF study will help physicians to understand the impact of monitoring fluctuations in pulmonary pressure.
The first phase will involve the deployment of either cardiac ablation or medication by physicians to control erratic heart rhythms in AFib patients with a history of heart failure.
All patients will be given Abbott Confirm Rx insertable cardiac monitor to help physicians monitor for recurrent abnormal heart rhythms, following treatment for AFib.
During the second phase, physicians will randomise patients to receive typical clinical management for heart failure based on symptom changes or to heart failure management guided by data from Abbott’s CardioMEMS HF system.
CardioMEMS HF is a pulmonary pressure sensor, which will be able to alert doctors with an early warning of deteriorating heart failure.
Abbott intends to recruit up to 100 patients at 10 US sites in the investigator-initiated phase four, sequential, randomised, open label and multicentre prospective comparative study.
The company will compare the outcomes of patients who had their heart failure management guided by data from the CardioMEMS HF system to those who received standard of care (medicine) for their heart failure at the end of the trial.
It will help determine which patient group had better outcomes based on the recurrence of AFib, hospitalisation or death.
In addition, the study will offer insights into the effect of catheter ablation in patients with HFpEF.