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Heart Rate Regularization in Atrial Fibrilation and Heart Failure (PACE-FIB)

Primary Purpose

Heart Failure, Atrial Fibrillation

Status

Recruiting

Phase

Not Applicable

Locations

Spain

Study Type

Interventional

Intervention

Conduction System Pacing (pacemaker implantation)

About this trial

This is an interventional treatment trial for Heart Failure focused on measuring atrial fibrillation;, heart failure;, conduction system pacing;, heart rate regularization

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Permanent atrial fibrillation
At least one episode of hospitalisation due to heart failure in the previous 12 months.
Left ventricular ejection fraction > 40%
Average resting heart rate ≤ 110 beats per minute
NT-proBNP ≥ 900 pg/ml in the 30 days prior to enrollment
Age ≥ 18 years
Capacity to understand the nature of the study, legal ability and willingness to give informed consent.

Exclusion Criteria:

Severe frailty (Clinical Frailty Scale ≥ 7) or comorbidity reducing life expectancy to < 12 months.
Acute heart failure at the time of enrollment or systolic blood pressure < 80 mmHg in the absence of inotropic agents.
Severe chronic kidney disease (estimated Glomerular Filtration Rate ≤ 20 ml/1,73 m2
Severe mitral or aortic valvular heart disease
Anaemia (Haemoglobin < 10 g/dl)
Morbid obesity (BMI ≥ 35)
Severe Chronic Obstructive Pulmonary Disease (Gold ≥ 3)
Presence of a different indication for pacing of implantable cardioverter-defibrillator (ICD)
Obstructive hypertrophic cardiomyopathy
Infiltrative cardiomyopathy (amyloidosis, sarcoidosis, Fabry disease, others)
Simultaneous participation in a different trial

Sites / Locations

Hospital Universitario 12 de OctubreRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Conduction System Pacing and AV node ablation

Medical treatment for rate control of AF

Arm Description

Atrioventricular node ablation and subsequent conduction system pacing

Pharmacological rate control based on clinical practice guidelines

Outcomes

Primary Outcome Measures

Composite primary endpoint

All-cause mortality, heart failure hospitalisation and worsening heart failure

Secondary Outcome Measures

All-cause mortality

Mortality due to any cause

Cardiovascular mortality

Mortality due to cardiovascular causes

Heart failure hospitalization

Hospitalization due to heart failure decompensation

Worsening heart failure

An episode of heart failure diagnosed based on symptoms, signs, imaging and analytical criteria that requires unplanned medical attention and intravenous diuretic therapy

Unplanned cardiovascular hospitalisation

Left ventricular ejection fraction

assessed by the Simpson method

Change in left ventricular dimension

end-diastolic and end-systolic volumes

Change in degree of mitral regurgitation

Change in functional status

Assessed by New York Heart Association (NYHA) on a I to IV scale (I being better functional status and IV worst possible functional status)

Major adverse events during or in the first 30-days following pacemaker implantation

Percentage of patients suffering one of the following: death, cardiac tamponade, perforation requiring cardiac surgery, pneumothorax, haemothorax, device infection, endocarditis, lead displacement requiring re-intervention

Major adverse events during or in the first 30-days following atrioventricular node ablation

Percentage of patients suffering one of the following: death, cardiac tamponade, perforation requiring cardiac surgery, puncture site vascular complications requiring vascular surgery

Full Information

NCT ID

NCT05029570

First Posted

August 26, 2021

Last Updated

March 3, 2023

Sponsor

Daniel Rodríguez Muñoz

Collaborators

Sociedad Castellana de Cardiologia

1. Study Identification

Unique Protocol Identification Number

NCT05029570

Brief Title

Heart Rate Regularization in Atrial Fibrilation and Heart Failure

Acronym

PACE-FIB

Official Title

Conduction System PACing and Atrioventricular Node Ablation in Patients With hEart Failure, Left Ventricular Ejection Fraction >40% and Permanent Atrial FIBrilation: the PACE-FIB Trial

Study Type

Interventional

2. Study Status

Record Verification Date

March 2023

Overall Recruitment Status

Recruiting

Study Start Date

April 29, 2022 (Actual)

Primary Completion Date

November 1, 2026 (Anticipated)

Study Completion Date

November 1, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Daniel Rodríguez Muñoz

Collaborators

Sociedad Castellana de Cardiologia

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The PACE-FIB trial is a multicentre, randomised, open-label clinical trial. Patients older than 18 years, with permanent AF, LVEF>40%, average resting heart rate ≤ 110 beats per minute (bpm), at least one hospitalisation due to HF in the previous year and basal NT-proBNP level>900 pg/ml will be randomised to either CSP and subsequent AV node ablation (intervention group) vs. pharmacologic rate control optimised according to clinical practice guidelines. The impact of both strategies on a composite primary endpoint of all-cause mortality, HF hospitalisation and worsening HF will be evaluated during a 36-month follow-up.

Detailed Description

Permanent atrial fibrillation (AF) causes beat-to-beat heart rate irregularity, which has shown to decrease cardiac output. Observational data suggest that heart rate regularization through atrioventricular (AV) node ablation and pacemaker implantation improves outcomes in heart failure (HF) patients. However, no trials have been conducted to assess its potential benefit in HF and left ventricular ejection fraction (LVEF)>40%, a population in whom treatment strategies effectively improving outcomes are scarce. The goal of this trial is to assess the benefit of heart rate regularization through AV node ablation and conduction system pacing (CSP) in patients with permanent AF and HF with preserved or mildly reduced systolic function. The investigators hypothesize that heart rate regularization added to physiological pacing - preventing the deleterious effect of right apical pacing - reduces mortality, HF hospitalisations or worsening HF in these patients.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Heart Failure, Atrial Fibrillation

Keywords

atrial fibrillation;, heart failure;, conduction system pacing;, heart rate regularization

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

Medical Device: Conduction System Pacing (pacemaker implantation)

Masking

Outcomes Assessor

Masking Description

Clinical outcomes will be adjudicated by the investigator and reviewed by the Clinical Events Committee, that will be blind to treatment received by the patient.

Allocation

Randomized

Enrollment

334 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Conduction System Pacing and AV node ablation

Arm Type

Experimental

Arm Description

Atrioventricular node ablation and subsequent conduction system pacing

Arm Title

Medical treatment for rate control of AF

Arm Type

No Intervention

Arm Description

Pharmacological rate control based on clinical practice guidelines

Intervention Type

Device

Intervention Name(s)

Conduction System Pacing (pacemaker implantation)

Other Intervention Name(s)

Atrioventricular node ablation

Intervention Description

Conduction System Pacing (pacemaker implantation) and Atrioventricular node ablation

Primary Outcome Measure Information:

Title

Composite primary endpoint

Description

All-cause mortality, heart failure hospitalisation and worsening heart failure

Time Frame

36 months

Secondary Outcome Measure Information:

Title

All-cause mortality

Description

Mortality due to any cause

Time Frame

36 months

Title

Cardiovascular mortality

Description

Mortality due to cardiovascular causes

Time Frame

36 months

Title

Heart failure hospitalization

Description

Hospitalization due to heart failure decompensation

Time Frame

36 months

Title

Worsening heart failure

Description

An episode of heart failure diagnosed based on symptoms, signs, imaging and analytical criteria that requires unplanned medical attention and intravenous diuretic therapy

Time Frame

36 months

Title

Unplanned cardiovascular hospitalisation

Description

Unplanned cardiovascular hospitalisation

Time Frame

36 months

Title

Left ventricular ejection fraction

Description

assessed by the Simpson method

Time Frame

12 months

Title

Change in left ventricular dimension

Description

end-diastolic and end-systolic volumes

Time Frame

12 months

Title

Change in degree of mitral regurgitation

Description

Change in degree of mitral regurgitation

Time Frame

12 months

Title

Change in functional status

Description

Assessed by New York Heart Association (NYHA) on a I to IV scale (I being better functional status and IV worst possible functional status)

Time Frame

36 months

Title

Major adverse events during or in the first 30-days following pacemaker implantation

Description

Time Frame

30 days

Title

Major adverse events during or in the first 30-days following atrioventricular node ablation

Description

Percentage of patients suffering one of the following: death, cardiac tamponade, perforation requiring cardiac surgery, puncture site vascular complications requiring vascular surgery

Time Frame

30 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Permanent atrial fibrillation At least one episode of hospitalisation due to heart failure in the previous 12 months. Left ventricular ejection fraction > 40% Average resting heart rate ≤ 110 beats per minute NT-proBNP ≥ 900 pg/ml in the 30 days prior to enrollment Age ≥ 18 years Capacity to understand the nature of the study, legal ability and willingness to give informed consent. Exclusion Criteria: Severe frailty (Clinical Frailty Scale ≥ 7) or comorbidity reducing life expectancy to < 12 months. Acute heart failure at the time of enrollment or systolic blood pressure < 80 mmHg in the absence of inotropic agents. Severe chronic kidney disease (estimated Glomerular Filtration Rate ≤ 20 ml/1,73 m2 Severe mitral or aortic valvular heart disease Anaemia (Haemoglobin < 10 g/dl) Morbid obesity (BMI ≥ 35) Severe Chronic Obstructive Pulmonary Disease (Gold ≥ 3) Presence of a different indication for pacing of implantable cardioverter-defibrillator (ICD) Obstructive hypertrophic cardiomyopathy Infiltrative cardiomyopathy (amyloidosis, sarcoidosis, Fabry disease, others) Simultaneous participation in a different trial

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Daniel Rodriguez Muñoz, MD, PhD

Phone

+34 917792742

danielantonio.rodriguez@salud.madrid.org

First Name & Middle Initial & Last Name or Official Title & Degree

Ana Isabel Castillo Varón, PhD

Phone

+34 917792742

aicastillo.imas12@h12o.es

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Fernando Arribas Ynsaurriaga, MD, PhD

Organizational Affiliation

Hospital Universitario 12 de Octubre

Official's Role

Study Chair

Facility Information:

Facility Name

Hospital Universitario 12 de Octubre

City

Madrid

ZIP/Postal Code

28041

Country

Spain

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Daniel Rodríguez Muñoz, MD, PhD

Phone

+34 917792742

danielantonio.rodriguez@salud.madrid.org

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Heart Rate Regularization in Atrial Fibrilation and Heart Failure

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