Atrial FibrillationPhase 4TAP-CHFNCT04160000
Treatment Of Atrial Fibrillation In Preserved Cardiac Function Heart Failure
A Phase 4 study testing Catheter ablation, Insertion of CardioMems Hemodynamic monitor and Empiric heart failure drug therapy in people with Atrial Fibrillation and Heart Failure, run by Electrophysiology Research Foundation at 9 sites in 3 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Atrial Fibrillation, Heart Failure, Diastolic Heart Failure
- What is being tested?
- Catheter ablation, Insertion of CardioMems Hemodynamic monitor and Empiric heart failure drug therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 360 participants
- Where
- 9 sitesin 3 countries
- Study dates
- 26 Jul 2020to 30 Jun 2025
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- Patients with HFpEF who were not on any drug therapy for HF or have uncontrolled hypertension defined as systolic BP >180 mm Hg at screening or >150 mm Hg on three or more antihypertensive drugs
- Patients with QRS duration of >120 ms and intraventricular conduction defects who are or maybe candidates for or have received ventricular resynchronization therapy
- Recent (<1 month) myocardial infarction or acute coronary syndrome
- Recent (<3 months) coronary revascularization procedures
- Documented LA thrombus on TEE or any LVEF measurement <40%
- Patients who are not candidates for Rate or Rhythm control drug therapy for AF
Show all 20Show fewer
- Dilated cardiomyopathy due to potentially reversible cause e.g. myocarditis
- Contraindications to anticoagulant therapy or adverse event with prior Warfarin or DOAC therapy
- Creatinine clearance <30ml/min or >95ml/min
- Advanced hepatic disease, pulmonary disease clinically significant congenital heart disease, clinically significant pericardial constriction, hypertrophic cardiomyopathy, infiltrative cardiomyopathy, decompensated valvular heart disease likely to require surgical or percutaneous intervention during the trial
- Recent stroke (<3 months) or thromboembolic event, transient ischemic attack or carotid angioplasty in the prior 3 months
- Recent (<3 months) intracranial or other major bleeding event
- Candidates for heart or any other organ transplantation or left ventricular assist devices, recent (< 3 months) valve or other cardiac surgery
- Patients requiring ACE inhibitor or ARB drug therapy for any reason
- History of hypersensitivity to antiarrhythmic drugs
- Patients with other clinically significant medical condition that precludes study participation
- Patients with life expectancy < 1 year
- Premenopausal female patients, who are not on continuous birth control therapy or are likely to discontinue it at any time during the entire duration of study enrollment.
- Pregnant or nursing lactating mothers or women of childbearing potential who are not on effective contraceptive therapy
- Patients who have been noncompliant with medical regimens or have social or other issues precluding regular follow up, history of alcohol or drug abuse in past 12 months.
Trial locations and contacts
9 sites in 3 countries.
9 sites in 3 countries
United States7 sites, 7 recruiting
- Recruiting
TCAI at St. David's Hospital
Austin, Texas, 78705
Andrea Natale, MD, dr.natale@gmail.com
Sangamitra Mohanty, MBBS, Mitra.Mohanty@stdavidsintl.com
- Recruiting
Northern Arizona Health Care
Flagstaff, Arizona, 86001
Paula McAllister, 928-214-3616, aula.mcallister@nahealth.com
Rangadham Nagarakanti
- Recruiting
St. Bernards Heart and Vascular Center
Jonesboro, Arkansas, 72401
Devi G Nair, MD, dr.devignair@gmail.com
Sydney Stevens, NP
- Recruiting
South Denver Cardiology
Littleton, Colorado, 80120
Sri Sundaram, MD, sris@southdenver.com
Mary Soltau, MSN, msoltau@southdenver.com
- Recruiting
Kansas City Heart Rhythm Institute
Overland, Missouri, 66211
Dhananjaya R Lakkireddy, MD, dlakkireddy@gmail.com
Jennifer Bush, MSN, jennifer.bush2@hcahealthcare.com
- Recruiting
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Mathew D Hyman, MD, matthew.hyman@pennmedicine.upenn.edu
Mary Gnap, mary.gnap@pennmedicine.upenn.edu
- Recruiting
Electrophysiology Research Foundation
Warren Township, New Jersey, 07059
Sanjeev Saksena, MBBS MD, 732-302-9988, eprf@aol.com
Carine Carvalheiro, 732-302-9990
Germany1 site, 1 recruiting
- Not yet recruiting
Peter Osypka Herzzentrum
Munich, Bavaria, 81379
Thorsten Lewalter, MD, thorsten.lewalter@osypka-herzzentrum.de
Clemens Jilek, MD, clemens.jilek@ikms.de
Switzerland1 site, 1 recruiting
- Recruiting
Hopitaux Universitaires de Geneve
Geneva, Canton of Geneva, 1205
Dipen Shah, MD, dipen.shah@hcuge.ch
Luca Galbiati, MD, luca.galbiati@hcuge.ch
About this study
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
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.
Read the 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 1:1 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 and/or 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
- Conditions
- Atrial Fibrillation, Heart Failure, Diastolic Heart Failure
- Being tested
- Catheter ablation, Rate or Rhythm control antiarrhythmic drugs for atrial fibrillation, Insertion of CardioMems Hemodynamic monitor, Empiric heart failure drug therapy
- Keywords
- Atrial fibrillation, Heart failure, Diastolic heart failure, Catheter Ablation, Antiarrhythmic Drugs
- Medical subject headings
- Atrial Fibrillation, Heart Failure, Heart Failure, Diastolic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Catheter ablationDevice
Also called Ablation
Delivery of physical energy from external energy source via percutaneously inserted electrophysiologic catheter to destroy heart tissue in the human atrium and adjoining vasculature
Rate or Rhythm control antiarrhythmic drugs for atrial fibrillationDrug
Also called Antiarrhythmic Drug
Administration of antiarrhythmic drug to achieve either rate control or restoration of sinus rhythm for management of atrial fibrillation
Insertion of CardioMems Hemodynamic monitorDevice
Also called IPM
Insertion of wireless hemodynamic monitor to provide hemodynamic data to guide heart failure therapy to achieve heart failure improvement.
Empiric heart failure drug therapyDrug
Also called HFDrug
Administration of heart failure drug therapy based on clinical evaluation to achieve heart failure improvement.
| Study group | Role | What they receive |
|---|---|---|
| Phase 1 Catheter Ablation | Active comparator | Patients with atrial fibrillation and heart failure with preserved systolic function will be enrolled after informed consent. They randomly assigned to catheter ablation as one arm. They will undergo a catheter ablation procedure within 14 days of randomization. This procedure will include isolation of all four pulmonary veins in the antrum using catheter delivered radiofrequency current, cryothermal or laser ablation energy with standard FDA approved ablation catheter systems used in atrial fibrillation ablation. Patients will be monitored for a minimum period of 9 months after the catheter ablation intervention. Receives: Device: Catheter ablation |
| Phase 1 Antiarrhythmic drug therapy | Active comparator | Patients with atrial fibrillation and heart failure with preserved systolic function will be enrolled after informed consent. They will be randomly assigned to antiarrhythmic drug therapy for Rate or Rhythm control in this arm. They will undergo drug dose titration within 14 days of randomization. . Patients will be monitored for a minimum period of 9 months after the AAD therapy initiation Receives: Drug: Rate or Rhythm control antiarrhythmic drugs for atrial fibrillation |
| Phase 2 Guided Heart Failure Therapy | Active comparator | Patients with atrial fibrillation and heart failure with preserved systolic function will be enrolled after informed consent and completion of Phase 1. They will be randomly assigned to insertion of an implantable hemodynamic monitor in this arm and heart failure therapy guided by wireless hemodynamic monitoring. Patients will be monitored for a minimum period of 9 months after the implantable hemodynamic monitor insertion on guided drug therapy Receives: Device: Insertion of CardioMems Hemodynamic monitor |
| Phase 2 Empiric Heart Failure Therapy | Active comparator | Patients with atrial fibrillation and heart failure with preserved systolic function will be enrolled after informed consent and completion of Phase 1. They will be randomly assigned to heart failure management with empirical selection of heart failure therapy. Patients will be monitored for a minimum period of 9 months after the initiation of empirically selected heart failure drug therapy Receives: Drug: Empiric heart failure drug therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to Composite of Heart failure hospitalizations and/or Cardiovascular mortality
Time to either first of Heart failure hospitalization and/or mortality due to cardiovascular etiology
Measured: From date of randomization until the date of first documented heart failure hospitalization or date of death from cardiovascular causes, whichever came first, assessed up to 12 months
Secondary outcomes (3)
All cause Mortality
Time to mortality due to any cause
Measured: From date of randomization until the date of death from any cause, assessed up to 12 months
MACE events
Time to major adverse cardiovascular event
Measured: From date of randomization until the date of first documented major adverse cardiovascular event, assessed up to 12 months
Cardiovascular Hospitalization
Time to first hospitalization due to cardiovascular causes
Measured: From date of randomization until the date of first documented hospitalization due to cardiovascular causes , assessed up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2019
- Study start26 Jul 2020
- Primary completion31 Dec 2024 (estimated)
- Study completion30 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a prospective pilot study utilizing a randomized comparative sequential evaluation of 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.
- Masking
- None (open label)
- Enrolment
- 360 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Electrophysiology Research Foundation
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sanjeev Saksena, MD, Study chair, Electrophysiology Research FoundationAndrea Natale, MD, Study director, Electrophysiology Research Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04160000
- Sponsor's protocol ID
- EPRF - 2019 - 11
- Acronym
- TAP-CHF
- Status last verified
- May 2024
- First submitted
- 6 Nov 2019
- Last updated
- 23 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Saksena S, Slee A. Atrial fibrillation and its pernicious role in heart failure with preserved ejection fraction: a new frontier in interventional electrophysiology. J Interv Card Electrophysiol. 2018 Mar;51(2):89-90. doi: 10.1007/s10840-018-0341-3. No abstract available.
PubMed 29480345Cikes M, Claggett B, Shah AM, Desai AS, Lewis EF, Shah SJ, Anand IS, O'Meara E, Rouleau JL, Sweitzer NK, Fang JC, Saksena S, Pitt B, Pfeffer MA, Solomon SD. Atrial Fibrillation in Heart Failure With Preserved Ejection Fraction: The TOPCAT Trial. JACC Heart Fail. 2018 Aug;6(8):689-697. doi: 10.1016/j.jchf.2018.05.005. Epub 2018 Jul 11.
PubMed 30007557Slee A, Saad M, Saksena S. Heart failure progression and mortality in atrial fibrillation patients with preserved or reduced left ventricular ejection fraction. J Interv Card Electrophysiol. 2019 Sep;55(3):325-331. doi: 10.1007/s10840-019-00534-x. Epub 2019 Mar 18.
PubMed 30887281Slee A, Saksena S. Impact of initial heart failure emergence on clinical outcomes of atrial fibrillation patients in the AFFIRM trial. Am Heart J. 2020 Feb;220:1-11. doi: 10.1016/j.ahj.2019.10.005. Epub 2019 Oct 28.
PubMed 31756389
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04160000
- Acronym / sponsor ID
- TAP-CHF / EPRF - 2019 - 11
- Conditions
- Atrial Fibrillation, Heart Failure, Diastolic Heart Failure
- Keywords
- Atrial fibrillation, Heart failure, Diastolic heart failure, Catheter Ablation, Antiarrhythmic Drugs
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 360 participants (estimated)
- Lead sponsor
- Electrophysiology Research FoundationUniversity, hospital or other
- Study start
- 26 Jul 2020 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 30 Jun 2025 (estimated)
- First posted
- 12 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 1:1 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 and/or 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- This is a prospective pilot study utilizing a randomized comparative sequential evaluation of 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.
| Arm | Type | Receives |
|---|---|---|
| Phase 1 Catheter Ablation | Active comparator | Device: Catheter ablationPatients with atrial fibrillation and heart failure with preserved systolic function will be enrolled after informed consent. They randomly assigned to catheter ablation as one arm. They will undergo a catheter ablation procedure within 14 days of randomization. This procedure will include isolation of all four pulmonary veins in the antrum using catheter delivered radiofrequency current, cryothermal or laser ablation energy with standard FDA approved ablation catheter systems used in atrial fibrillation ablation. Patients will be monitored for a minimum period of 9 months after the catheter ablation intervention. |
| Phase 1 Antiarrhythmic drug therapy | Active comparator | Drug: Rate or Rhythm control antiarrhythmic drugs for atrial fibrillationPatients with atrial fibrillation and heart failure with preserved systolic function will be enrolled after informed consent. They will be randomly assigned to antiarrhythmic drug therapy for Rate or Rhythm control in this arm. They will undergo drug dose titration within 14 days of randomization. . Patients will be monitored for a minimum period of 9 months after the AAD therapy initiation |
| Phase 2 Guided Heart Failure Therapy | Active comparator | Device: Insertion of CardioMems Hemodynamic monitorPatients with atrial fibrillation and heart failure with preserved systolic function will be enrolled after informed consent and completion of Phase 1. They will be randomly assigned to insertion of an implantable hemodynamic monitor in this arm and heart failure therapy guided by wireless hemodynamic monitoring. Patients will be monitored for a minimum period of 9 months after the implantable hemodynamic monitor insertion on guided drug therapy |
| Phase 2 Empiric Heart Failure Therapy | Active comparator | Drug: Empiric heart failure drug therapyPatients with atrial fibrillation and heart failure with preserved systolic function will be enrolled after informed consent and completion of Phase 1. They will be randomly assigned to heart failure management with empirical selection of heart failure therapy. Patients will be monitored for a minimum period of 9 months after the initiation of empirically selected heart failure drug therapy |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (20 listed)
- Patients with HFpEF who were not on any drug therapy for HF or have uncontrolled hypertension defined as systolic BP >180 mm Hg at screening or >150 mm Hg on three or more antihypertensive drugs
- Patients with QRS duration of >120 ms and intraventricular conduction defects who are or maybe candidates for or have received ventricular resynchronization therapy
- Recent (<1 month) myocardial infarction or acute coronary syndrome
- Recent (<3 months) coronary revascularization procedures
- Documented LA thrombus on TEE or any LVEF measurement <40%
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Catheter ablationAlso: AblationDelivery of physical energy from external energy source via percutaneously inserted electrophysiologic catheter to destroy heart tissue in the human atrium and adjoining vasculature | Device | Phase 1 Catheter Ablation |
| Rate or Rhythm control antiarrhythmic drugs for atrial fibrillationAlso: Antiarrhythmic DrugAdministration of antiarrhythmic drug to achieve either rate control or restoration of sinus rhythm for management of atrial fibrillation | Drug | Phase 1 Antiarrhythmic drug therapy |
| Insertion of CardioMems Hemodynamic monitorAlso: IPMInsertion of wireless hemodynamic monitor to provide hemodynamic data to guide heart failure therapy to achieve heart failure improvement. | Device | Phase 2 Guided Heart Failure Therapy |
| Empiric heart failure drug therapyAlso: HFDrugAdministration of heart failure drug therapy based on clinical evaluation to achieve heart failure improvement. | Drug | Phase 2 Empiric Heart Failure Therapy |
Primary outcome
Time to Composite of Heart failure hospitalizations and/or Cardiovascular mortality
Time frame: From date of randomization until the date of first documented heart failure hospitalization or date of death from cardiovascular causes, whichever came first, assessed up to 12 months
Time to either first of Heart failure hospitalization and/or mortality due to cardiovascular etiology
3 secondary outcomes
All cause Mortality
Time frame: From date of randomization until the date of death from any cause, assessed up to 12 months
MACE events
Time frame: From date of randomization until the date of first documented major adverse cardiovascular event, assessed up to 12 months
Cardiovascular Hospitalization
Time frame: From date of randomization until the date of first documented hospitalization due to cardiovascular causes , assessed up to 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2024.
- Background: PubMed 29480345Saksena S, Slee A. Atrial fibrillation and its pernicious role in heart failure with preserved ejection fraction: a new frontier in interventional electrophysiology. J Interv Card Electrophysiol. 2018 Mar;51(2):89-90. doi: 10.1007/s10840-018-0341-3. No abstract available.
- Background: PubMed 30007557Cikes M, Claggett B, Shah AM, Desai AS, Lewis EF, Shah SJ, Anand IS, O'Meara E, Rouleau JL, Sweitzer NK, Fang JC, Saksena S, Pitt B, Pfeffer MA, Solomon SD. Atrial Fibrillation in Heart Failure With Preserved Ejection Fraction: The TOPCAT Trial. JACC Heart Fail. 2018 Aug;6(8):689-697. doi: 10.1016/j.jchf.2018.05.005. Epub 2018 Jul 11.
- Background: PubMed 30887281Slee A, Saad M, Saksena S. Heart failure progression and mortality in atrial fibrillation patients with preserved or reduced left ventricular ejection fraction. J Interv Card Electrophysiol. 2019 Sep;55(3):325-331. doi: 10.1007/s10840-019-00534-x. Epub 2019 Mar 18.
- Background: PubMed 31756389Slee A, Saksena S. Impact of initial heart failure emergence on clinical outcomes of atrial fibrillation patients in the AFFIRM trial. Am Heart J. 2020 Feb;220:1-11. doi: 10.1016/j.ahj.2019.10.005. Epub 2019 Oct 28.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sanjeev Saksena, MD study chair
Electrophysiology Research Foundation
Andrea Natale, MD study director
Electrophysiology Research Foundation
9 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Catheter ablation, Insertion of CardioMems Hemodynamic monitor and Empiric heart failure drug therapy in people with Atrial Fibrillation and Heart Failure, run by Electrophysiology Research Foundation at 9 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United States, Germany, Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact SANJEEV SAKSENA, MD (7323029990 ext. 7323029990, cmenj@aol.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to Composite of Heart failure hospitalizations and/or Cardiovascular mortality (time frame: From date of randomization until the date of first documented heart failure hospitalization or date of death from cardiovascular causes, whichever came first, assessed up to 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04160000, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 May 2024.