Heart Failure With Preserved Ejection FractionAF-HFpEFNCT04327596
Radiofrequency (RF) Ablation for Atrial Fibrillation (AF) in Patients With Heart Failure With Preserved Ejection Fraction
A study testing RF ablation of AF using CARTO 3 and a Thermocool ST SF ablation catheter in people with Heart Failure With Preserved Ejection Fraction, run by University of Rochester at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Heart Failure With Preserved Ejection Fraction
- What is being tested?
- RF ablation of AF using CARTO 3 and a Thermocool ST SF ablation catheter
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 2 sitesUnited States
- Study dates
- 25 Jan 2021to 21 Sep 2021
- Phase
- Interventional
- 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 25Show fewer
- 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.
- Untreated hypothyroidism or hyperthyroidism but may be re-considered for enrollment later after effective treatment.
- Pregnancy or nursing.
- Valvular AF or presence of a prosthetic valve.
- Undergoing dialysis or have advanced renal dysfunction (eGFR <30 ml/min/m2) defined as 3 times the upper limits of AST or ALT during the past 6 calendar months.
- Contraindication to anticoagulation.
- Metabolic derangements (e.g. renal/hepatic failure, electrolyte disturbance, etc.), prohibiting study (EP) study and ablation.
- Cognitive impairment.
- Life expectancy < 1 year following consent date.
- Unwilling to comply with all study protocol-required testing.
- Unwilling or unable to give informed consent.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Rochester Regional Health
Rochester, New York, 14621
University of Rochester Medical Center
Rochester, New York, 14642
About this study
Official title: Randomized Clinical Trial of Radiofrequency Ablation for Atrial Fibrillation in Patients With Heart Failure With Preserved Ejection Fraction for Reduced Healthcare Utilization
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.
Read the detailed description
In this study, subjects with HFpEF and new onset paroxysmal or persistent AF (diagnosed in the past 6 months) will be randomized in a 1:1 ratio to either intervention or medical therapy alone. Twenty subjects will be enrolled to each group for a total of 40 subjects across all enrolling sites. Subjects randomized to the intervention Group will undergo early RF ablation of AF using CARTO 3 and a Thermocool ST SF ablation catheter. The medical therapy alone cohort will receive management of AF consisting of either rate or rhythm control. All patients will be implanted with an implantable cardiac monitor (ICM) as standard of care for AF management in heart failure except for those who already have in place an existing cardiac implantable electronic device (CIED) such as pacemaker, ICM, or implantable cardiac defibrillator (ICD). The ICM procedure will occur within 2 calendar months of randomization for both study groups (intervention or control). For the intervention arm, the CIED procedure will occur prior to or at the time of the AF ablation procedure. Subjects will be followed for 1 year with in-clinic visits occurring at 3, 6, and 12 months.
- Being tested
- RF ablation of AF using CARTO 3 and a Thermocool ST SF ablation catheter
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RF ablation of AF using CARTO 3 and a Thermocool ST SF ablation catheterProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Procedure: RF ablation of AF using CARTO 3 and a Thermocool ST SF ablation catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of healthcare utilization.
Number of unplanned office visits, hospitalizations, and emergency room visits.
Measured: up to 12 months
Secondary outcomes (4)
Burden of Atrial Fibrillation (AF)
Percentage of time spent in AF (i.e. amount of time spent in AF divided by the total amount of CIED monitoring time).
Measured: Between baseline and 12 months
Change in quality of life measures in Patient-Reported Outcomes Measurement Information System (PROMIS).
Consists of 24 questions with a scale of 1-5 with 1 being the worst
Measured: Between baseline and 6 months
6-minute Walk Test
Mean changes in functional status
Measured: 6 Months
Quality of life measures using the Kansas City Cardiomyopathy Questionnaire (KCCQ)
Consists of 8 questions with a scale of 1-5 with 1 being the worst
Measured: Between baseline and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2020
- Study start25 Jan 2021
- Primary completion21 Sep 2021
- Study completion21 Sep 2021
Why it stopped: lack of enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (32)Papers the sponsor has linked to this study.
- Other trials for Heart Failure With Preserved Ejection FractionStudies of the same condition, open and under way.
- More trials run by University of RochesterThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Model description
- Subjects will undergo early RF ablation of AF using CARTO 3 and a Thermocool ST SF ablation catheter.
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Rochester
- Sponsor type
- University, hospital or other
- Collaborators
- Biosense Webster, Inc.
- Responsible party
- Principal investigator, Mehmet Aktas, University of Rochester
- Investigators
- Mehmet K Aktas, MD, Principal investigator, University of Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04327596
- Sponsor's protocol ID
- 00004367
- Acronym
- AF-HFpEF
- Status last verified
- Feb 2022
- First submitted
- 27 Mar 2020
- Last updated
- 23 Feb 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Benjamin EJ, Virani SS, Callaway CW, Chamberlain AM, Chang AR, Cheng S, Chiuve SE, Cushman M, Delling FN, Deo R, de Ferranti SD, Ferguson JF, Fornage M, Gillespie C, Isasi CR, Jimenez MC, Jordan LC, Judd SE, Lackland D, Lichtman JH, Lisabeth L, Liu S, Longenecker CT, Lutsey PL, Mackey JS, Matchar DB, Matsushita K, Mussolino ME, Nasir K, O'Flaherty M, Palaniappan LP, Pandey A, Pandey DK, Reeves MJ, Ritchey MD, Rodriguez CJ, Roth GA, Rosamond WD, Sampson UKA, Satou GM, Shah SH, Spartano NL, Tirschwell DL, Tsao CW, Voeks JH, Willey JZ, Wilkins JT, Wu JH, Alger HM, Wong SS, Muntner P; American Heart Association Council on Epidemiology and Prevention Statistics Committee and Stroke Statistics Subcommittee. Heart Disease and Stroke Statistics-2018 Update: A Report From the American Heart Association. Circulation. 2018 Mar 20;137(12):e67-e492. doi: 10.1161/CIR.0000000000000558. Epub 2018 Jan 31. No abstract available.
PubMed 29386200Heidenreich PA, Albert NM, Allen LA, Bluemke DA, Butler J, Fonarow GC, Ikonomidis JS, Khavjou O, Konstam MA, Maddox TM, Nichol G, Pham M, Pina IL, Trogdon JG; American Heart Association Advocacy Coordinating Committee; Council on Arteriosclerosis, Thrombosis and Vascular Biology; Council on Cardiovascular Radiology and Intervention; Council on Clinical Cardiology; Council on Epidemiology and Prevention; Stroke Council. Forecasting the impact of heart failure in the United States: a policy statement from the American Heart Association. Circ Heart Fail. 2013 May;6(3):606-19. doi: 10.1161/HHF.0b013e318291329a. Epub 2013 Apr 24.
PubMed 23616602Loehr LR, Rosamond WD, Chang PP, Folsom AR, Chambless LE. Heart failure incidence and survival (from the Atherosclerosis Risk in Communities study). Am J Cardiol. 2008 Apr 1;101(7):1016-22. doi: 10.1016/j.amjcard.2007.11.061. Epub 2008 Feb 14.
PubMed 18359324Owan TE, Hodge DO, Herges RM, Jacobsen SJ, Roger VL, Redfield MM. Trends in prevalence and outcome of heart failure with preserved ejection fraction. N Engl J Med. 2006 Jul 20;355(3):251-9. doi: 10.1056/NEJMoa052256.
PubMed 16855265Kotecha D, Lam CS, Van Veldhuisen DJ, Van Gelder IC, Voors AA, Rienstra M. Heart Failure With Preserved Ejection Fraction and Atrial Fibrillation: Vicious Twins. J Am Coll Cardiol. 2016 Nov 15;68(20):2217-2228. doi: 10.1016/j.jacc.2016.08.048.
PubMed 27855811Packer M, Colucci WS, Sackner-Bernstein JD, Liang CS, Goldscher DA, Freeman I, Kukin ML, Kinhal V, Udelson JE, Klapholz M, Gottlieb SS, Pearle D, Cody RJ, Gregory JJ, Kantrowitz NE, LeJemtel TH, Young ST, Lukas MA, Shusterman NH. Double-blind, placebo-controlled study of the effects of carvedilol in patients with moderate to severe heart failure. The PRECISE Trial. Prospective Randomized Evaluation of Carvedilol on Symptoms and Exercise. Circulation. 1996 Dec 1;94(11):2793-9. doi: 10.1161/01.cir.94.11.2793.
PubMed 8941104CONSENSUS Trial Study Group. Effects of enalapril on mortality in severe congestive heart failure. Results of the Cooperative North Scandinavian Enalapril Survival Study (CONSENSUS). N Engl J Med. 1987 Jun 4;316(23):1429-35. doi: 10.1056/NEJM198706043162301.
PubMed 2883575Cohn JN, Tognoni G; Valsartan Heart Failure Trial Investigators. A randomized trial of the angiotensin-receptor blocker valsartan in chronic heart failure. N Engl J Med. 2001 Dec 6;345(23):1667-75. doi: 10.1056/NEJMoa010713.
PubMed 11759645Pitt B, Zannad F, Remme WJ, Cody R, Castaigne A, Perez A, Palensky J, Wittes J. The effect of spironolactone on morbidity and mortality in patients with severe heart failure. Randomized Aldactone Evaluation Study Investigators. N Engl J Med. 1999 Sep 2;341(10):709-17. doi: 10.1056/NEJM199909023411001.
PubMed 10471456Massie BM, Carson PE, McMurray JJ, Komajda M, McKelvie R, Zile MR, Anderson S, Donovan M, Iverson E, Staiger C, Ptaszynska A; I-PRESERVE Investigators. Irbesartan in patients with heart failure and preserved ejection fraction. N Engl J Med. 2008 Dec 4;359(23):2456-67. doi: 10.1056/NEJMoa0805450. Epub 2008 Nov 11.
PubMed 19001508Cleland JG, Tendera M, Adamus J, Freemantle N, Polonski L, Taylor J; PEP-CHF Investigators. The perindopril in elderly people with chronic heart failure (PEP-CHF) study. Eur Heart J. 2006 Oct;27(19):2338-45. doi: 10.1093/eurheartj/ehl250. Epub 2006 Sep 8.
PubMed 16963472Pitt B, Pfeffer MA, Assmann SF, Boineau R, Anand IS, Claggett B, Clausell N, Desai AS, Diaz R, Fleg JL, Gordeev I, Harty B, Heitner JF, Kenwood CT, Lewis EF, O'Meara E, Probstfield JL, Shaburishvili T, Shah SJ, Solomon SD, Sweitzer NK, Yang S, McKinlay SM; TOPCAT Investigators. Spironolactone for heart failure with preserved ejection fraction. N Engl J Med. 2014 Apr 10;370(15):1383-92. doi: 10.1056/NEJMoa1313731.
PubMed 24716680Yamamoto K, Origasa H, Hori M; J-DHF Investigators. Effects of carvedilol on heart failure with preserved ejection fraction: the Japanese Diastolic Heart Failure Study (J-DHF). Eur J Heart Fail. 2013 Jan;15(1):110-8. doi: 10.1093/eurjhf/hfs141. Epub 2012 Sep 14.
PubMed 22983988Yusuf S, Pfeffer MA, Swedberg K, Granger CB, Held P, McMurray JJ, Michelson EL, Olofsson B, Ostergren J; CHARM Investigators and Committees. Effects of candesartan in patients with chronic heart failure and preserved left-ventricular ejection fraction: the CHARM-Preserved Trial. Lancet. 2003 Sep 6;362(9386):777-81. doi: 10.1016/S0140-6736(03)14285-7.
PubMed 13678871Santhanakrishnan R, Wang N, Larson MG, Magnani JW, McManus DD, Lubitz SA, Ellinor PT, Cheng S, Vasan RS, Lee DS, Wang TJ, Levy D, Benjamin EJ, Ho JE. Atrial Fibrillation Begets Heart Failure and Vice Versa: Temporal Associations and Differences in Preserved Versus Reduced Ejection Fraction. Circulation. 2016 Feb 2;133(5):484-92. doi: 10.1161/CIRCULATIONAHA.115.018614. Epub 2016 Jan 8.
PubMed 26746177
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Clinical Trial of Radiofrequency Ablation for Atrial Fibrillation in Patients With Heart Failure With Preserved Ejection Fraction for Reduced Healthcare Utilization
- ClinicalTrials.gov ID
- NCT04327596
- Acronym / sponsor ID
- AF-HFpEF / 00004367
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: lack of enrollment
- Enrolment
- 2 participants (actual)
- Lead sponsor
- University of RochesterUniversity, hospital or other
- Collaborators
- Biosense Webster, Inc.
- Study start
- 25 Jan 2021 (actual)
- Primary completion
- 21 Sep 2021 (actual)
- Study completion
- 21 Sep 2021 (actual)
- First posted
- 31 Mar 2020 (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.
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.
Detailed description
In this study, subjects with HFpEF and new onset paroxysmal or persistent AF (diagnosed in the past 6 months) will be randomized in a 1:1 ratio to either intervention or medical therapy alone. Twenty subjects will be enrolled to each group for a total of 40 subjects across all enrolling sites. Subjects randomized to the intervention Group will undergo early RF ablation of AF using CARTO 3 and a Thermocool ST SF ablation catheter. The medical therapy alone cohort will receive management of AF consisting of either rate or rhythm control. All patients will be implanted with an implantable cardiac monitor (ICM) as standard of care for AF management in heart failure except for those who already have in place an existing cardiac implantable electronic device (CIED) such as pacemaker, ICM, or implantable cardiac defibrillator (ICD). The ICM procedure will occur within 2 calendar months of randomization for both study groups (intervention or control). For the intervention arm, the CIED procedure will occur prior to or at the time of the AF ablation procedure. Subjects will be followed for 1 year with in-clinic visits occurring at 3, 6, and 12 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Subjects will undergo early RF ablation of AF using CARTO 3 and a Thermocool ST SF ablation catheter.
| Arm | Type | Receives |
|---|---|---|
| Conventional Treatment | No intervention | –Subjects will receive management of AF consisting of either rate or rhythm control. |
| AF Ablation | Active comparator | Procedure: RF ablation of AF using CARTO 3 and a Thermocool ST SF ablation catheterSubjects will undergo early RF ablation of AF using CARTO 3 and a Thermocool ST SF ablation catheter |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (25 listed)
- 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.
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 |
|---|---|---|
| RF ablation of AF using CARTO 3 and a Thermocool ST SF ablation catheterAblation 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. | Procedure or surgery | AF Ablation |
Primary outcome
Rate of healthcare utilization.
Time frame: up to 12 months
Number of unplanned office visits, hospitalizations, and emergency room visits.
4 secondary outcomes
Burden of Atrial Fibrillation (AF)
Time frame: Between baseline and 12 months
Change in quality of life measures in Patient-Reported Outcomes Measurement Information System (PROMIS).
Time frame: Between baseline and 6 months
6-minute Walk Test
Time frame: 6 Months
Quality of life measures using the Kansas City Cardiomyopathy Questionnaire (KCCQ)
Time frame: Between baseline and 6 months
Results and safety
The study was stopped early (reason given: lack of enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2022.
- Background: PubMed 29386200Benjamin EJ, Virani SS, Callaway CW, Chamberlain AM, Chang AR, Cheng S, Chiuve SE, Cushman M, Delling FN, Deo R, de Ferranti SD, Ferguson JF, Fornage M, Gillespie C, Isasi CR, Jimenez MC, Jordan LC, Judd SE, Lackland D, Lichtman JH, Lisabeth L, Liu S, Longenecker CT, Lutsey PL, Mackey JS, Matchar DB, Matsushita K, Mussolino ME, Nasir K, O'Flaherty M, Palaniappan LP, Pandey A, Pandey DK, Reeves MJ, Ritchey MD, Rodriguez CJ, Roth GA, Rosamond WD, Sampson UKA, Satou GM, Shah SH, Spartano NL, Tirschwell DL, Tsao CW, Voeks JH, Willey JZ, Wilkins JT, Wu JH, Alger HM, Wong SS, Muntner P; American Heart Association Council on Epidemiology and Prevention Statistics Committee and Stroke Statistics Subcommittee. Heart Disease and Stroke Statistics-2018 Update: A Report From the American Heart Association. Circulation. 2018 Mar 20;137(12):e67-e492. doi: 10.1161/CIR.0000000000000558. Epub 2018 Jan 31. No abstract available.
- Background: PubMed 23616602Heidenreich PA, Albert NM, Allen LA, Bluemke DA, Butler J, Fonarow GC, Ikonomidis JS, Khavjou O, Konstam MA, Maddox TM, Nichol G, Pham M, Pina IL, Trogdon JG; American Heart Association Advocacy Coordinating Committee; Council on Arteriosclerosis, Thrombosis and Vascular Biology; Council on Cardiovascular Radiology and Intervention; Council on Clinical Cardiology; Council on Epidemiology and Prevention; Stroke Council. Forecasting the impact of heart failure in the United States: a policy statement from the American Heart Association. Circ Heart Fail. 2013 May;6(3):606-19. doi: 10.1161/HHF.0b013e318291329a. Epub 2013 Apr 24.
- Background: PubMed 18359324Loehr LR, Rosamond WD, Chang PP, Folsom AR, Chambless LE. Heart failure incidence and survival (from the Atherosclerosis Risk in Communities study). Am J Cardiol. 2008 Apr 1;101(7):1016-22. doi: 10.1016/j.amjcard.2007.11.061. Epub 2008 Feb 14.
- Background: PubMed 16855265Owan TE, Hodge DO, Herges RM, Jacobsen SJ, Roger VL, Redfield MM. Trends in prevalence and outcome of heart failure with preserved ejection fraction. N Engl J Med. 2006 Jul 20;355(3):251-9. doi: 10.1056/NEJMoa052256.
- Background: PubMed 27855811Kotecha D, Lam CS, Van Veldhuisen DJ, Van Gelder IC, Voors AA, Rienstra M. Heart Failure With Preserved Ejection Fraction and Atrial Fibrillation: Vicious Twins. J Am Coll Cardiol. 2016 Nov 15;68(20):2217-2228. doi: 10.1016/j.jacc.2016.08.048.
- Background: PubMed 8941104Packer M, Colucci WS, Sackner-Bernstein JD, Liang CS, Goldscher DA, Freeman I, Kukin ML, Kinhal V, Udelson JE, Klapholz M, Gottlieb SS, Pearle D, Cody RJ, Gregory JJ, Kantrowitz NE, LeJemtel TH, Young ST, Lukas MA, Shusterman NH. Double-blind, placebo-controlled study of the effects of carvedilol in patients with moderate to severe heart failure. The PRECISE Trial. Prospective Randomized Evaluation of Carvedilol on Symptoms and Exercise. Circulation. 1996 Dec 1;94(11):2793-9. doi: 10.1161/01.cir.94.11.2793.
- Background: PubMed 2883575CONSENSUS Trial Study Group. Effects of enalapril on mortality in severe congestive heart failure. Results of the Cooperative North Scandinavian Enalapril Survival Study (CONSENSUS). N Engl J Med. 1987 Jun 4;316(23):1429-35. doi: 10.1056/NEJM198706043162301.
- Background: PubMed 11759645Cohn JN, Tognoni G; Valsartan Heart Failure Trial Investigators. A randomized trial of the angiotensin-receptor blocker valsartan in chronic heart failure. N Engl J Med. 2001 Dec 6;345(23):1667-75. doi: 10.1056/NEJMoa010713.
- Background: PubMed 10471456Pitt B, Zannad F, Remme WJ, Cody R, Castaigne A, Perez A, Palensky J, Wittes J. The effect of spironolactone on morbidity and mortality in patients with severe heart failure. Randomized Aldactone Evaluation Study Investigators. N Engl J Med. 1999 Sep 2;341(10):709-17. doi: 10.1056/NEJM199909023411001.
- Background: PubMed 19001508Massie BM, Carson PE, McMurray JJ, Komajda M, McKelvie R, Zile MR, Anderson S, Donovan M, Iverson E, Staiger C, Ptaszynska A; I-PRESERVE Investigators. Irbesartan in patients with heart failure and preserved ejection fraction. N Engl J Med. 2008 Dec 4;359(23):2456-67. doi: 10.1056/NEJMoa0805450. Epub 2008 Nov 11.
- Background: PubMed 16963472Cleland JG, Tendera M, Adamus J, Freemantle N, Polonski L, Taylor J; PEP-CHF Investigators. The perindopril in elderly people with chronic heart failure (PEP-CHF) study. Eur Heart J. 2006 Oct;27(19):2338-45. doi: 10.1093/eurheartj/ehl250. Epub 2006 Sep 8.
- Background: PubMed 24716680Pitt B, Pfeffer MA, Assmann SF, Boineau R, Anand IS, Claggett B, Clausell N, Desai AS, Diaz R, Fleg JL, Gordeev I, Harty B, Heitner JF, Kenwood CT, Lewis EF, O'Meara E, Probstfield JL, Shaburishvili T, Shah SJ, Solomon SD, Sweitzer NK, Yang S, McKinlay SM; TOPCAT Investigators. Spironolactone for heart failure with preserved ejection fraction. N Engl J Med. 2014 Apr 10;370(15):1383-92. doi: 10.1056/NEJMoa1313731.
- 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.
Mehmet K Aktas, MD principal investigator
University of Rochester
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RF ablation of AF using CARTO 3 and a Thermocool ST SF ablation catheter in people with Heart Failure With Preserved Ejection Fraction, run by University of Rochester at 2 sites in United States.
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 7 inclusion and 25 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: stopped early, as of the sponsor's last update on 23 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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.
Are results available for this study?
The study was stopped early (reason given: lack of enrollment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of healthcare utilization. (time frame: 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 NCT04327596, which also lists 32 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 Feb 2022.