Physiological Pacing for AV Block to Prevent Pacemaker-induced Cardiomyopathy (PHYSPAVB)
Primary Purpose
Conduction System Pacing, Conventional Ventricular Pacing
Status
Recruiting
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Pacemaker implantation and conventional cardiac pacing
Conduction system pacing implant
Sponsored by
About this trial
This is an interventional treatment trial for Conduction System Pacing focused on measuring Pacemaker-induced cardiomyopathy
Eligibility Criteria
Inclusion Criteria:
- The patient must be ≥ 18 years of age.
- The patient must indicate their acceptance to participate in the study by signing an informed consent document.
- Patients with EF> 50% and indication for pacemaker implantation due to atrial-ventricular block according to current clinical guidelines.
Exclusion Criteria:
- Inability to understand and sign the informed consent.
- Patients with severe comorbidities and life expectancy <1 year.
- Patients with severe cognitive impairment or other comorbidities resulting in dependence for basic activities of daily life.
- Patients who cannot come to our center to carry out the follow-up of the study.
Sites / Locations
- Hospital Clinic of BarcelonaRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Conventional stimulation
Physiological stimulation
Arm Description
An electrode (in the apical or septal portion) will be implanted at the discretion of the implanter physician. Parameters of (sensing, impedance and threshold) will be measured as is usually done in our center.
Pacing the his-purkinje system.
Outcomes
Primary Outcome Measures
Compare the incidence of pacemaker-induced heart disease
Pacemaker induced cardiomyopathy defined as appearance of ventricular dysfunction LVEF <45% or admission due to heart failure.
Secondary Outcome Measures
Change in end-systolic volume.
VTSVI
Correction of septal flash.
Correction of septal flash determined with echocardiography (M mode)
Incidence of new onset of atrial fibrillation.
Hospitalization due to heart failure.
Hospitalization: patient hospitalization (yes/no)
New York Heart Association functional classification.
Class I - No symptoms and no limitation in ordinary physical activity, e.g. shortness of breath when walking, climbing stairs etc.
Class II - Mild symptoms (mild shortness of breath and/or angina) and slight limitation during ordinary activity.
Class III - Marked limitation in activity due to symptoms, even during less-than-ordinary activity, e.g. walking short distances (20-100 m).Comfortable only at rest.
Class IV - Severe limitations. Experiences symptoms even while at rest. Mostly bedbound patients.
Pacing thresholds.
Pacing thresholds.
Total implantation and electrode implantation times.
Total implantation and electrode implantation times.
Adverse events.
Resulted in reintervention or the termination of significant device function
Six minute walking test.
Six minute walking test.
The Quality of Life Scale.
The Minnesota living with heart failure questionnaire. The most widely used health-related quality of life questionnaires for patients with heart failure. Values from 0 to 105 (more is worse).
NT-proBNP.
NT-proBNP measure
Full Information
NCT ID
NCT05214365
First Posted
January 17, 2022
Last Updated
June 28, 2023
Sponsor
Hospital Clinic of Barcelona
Collaborators
Institut d'Investigacions Biomèdiques August Pi i Sunyer, Centro de Investigación Biomédica en Red Enfermedades Cardiovasculares (CIBERCV)
1. Study Identification
Unique Protocol Identification Number
NCT05214365
Brief Title
Physiological Pacing for AV Block to Prevent Pacemaker-induced Cardiomyopathy
Acronym
PHYSPAVB
Official Title
Physiological Pacing vs.Conventional Pacing in the Prevention of Pacemaker-induced Cardiomyopathy: A Randomized Study
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 1, 2022 (Actual)
Primary Completion Date
February 1, 2024 (Anticipated)
Study Completion Date
June 1, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital Clinic of Barcelona
Collaborators
Institut d'Investigacions Biomèdiques August Pi i Sunyer, Centro de Investigación Biomédica en Red Enfermedades Cardiovasculares (CIBERCV)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No
5. Study Description
Brief Summary
The implantation of a pacemaker and conventional cardiac pacing from the right ventricle (apex or septum) is an effective and safe therapy for the treatment of patients with atrioventricular block and bradycardia.
Detailed Description
Pacemaker implantation and conventional cardiac stimulation from the right ventricle is an effective and safe therapy for the treatment of patients with atrioventricular block and bradycardia. But it can cause worsening of heart function, with a significant drop in LV ejection fraction, known as pacemaker-induced cardiomyopathy (PICM).
Conduction system pacing (either by his or left bundle branch pacing) causes a physiological left ventricular activation through the normal conduction system thus correcting the electrical and mechanical asynchrony caused by conventional pacing. Conduction system pacing may prevent the appareance of PICM.
Clinical, electrocardiographic, echocardiographic follow-up will be performed for 1 year.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Conduction System Pacing, Conventional Ventricular Pacing
Keywords
Pacemaker-induced cardiomyopathy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized, unicentric, simple blind.
Masking
Participant
Masking Description
The patient will be explained to be randomized to either one of the two branches. The type of therapy applied will not be communicated to the patient. The follow-up will be the same in the two branches. During the visits it will not be said which therapy has been applied.
Allocation
Randomized
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Conventional stimulation
Arm Type
Active Comparator
Arm Description
An electrode (in the apical or septal portion) will be implanted at the discretion of the implanter physician. Parameters of (sensing, impedance and threshold) will be measured as is usually done in our center.
Arm Title
Physiological stimulation
Arm Type
Active Comparator
Arm Description
Pacing the his-purkinje system.
Intervention Type
Device
Intervention Name(s)
Pacemaker implantation and conventional cardiac pacing
Intervention Description
Patients will have the pacemaker implanted in the electrophysiology laboratory. Electrode will be implanted (in the apical or septal portion) according to the criteria of the implanting physician.
Intervention Type
Device
Intervention Name(s)
Conduction system pacing implant
Intervention Description
Right ventricular lead was placed to get his bundle or left bundle branch.
Primary Outcome Measure Information:
Title
Compare the incidence of pacemaker-induced heart disease
Description
Pacemaker induced cardiomyopathy defined as appearance of ventricular dysfunction LVEF <45% or admission due to heart failure.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Change in end-systolic volume.
Description
VTSVI
Time Frame
12 Months
Title
Correction of septal flash.
Description
Correction of septal flash determined with echocardiography (M mode)
Time Frame
12 Months
Title
Incidence of new onset of atrial fibrillation.
Time Frame
12 Months
Title
Hospitalization due to heart failure.
Description
Hospitalization: patient hospitalization (yes/no)
Time Frame
12 Months
Title
New York Heart Association functional classification.
Description
Class I - No symptoms and no limitation in ordinary physical activity, e.g. shortness of breath when walking, climbing stairs etc.
Class II - Mild symptoms (mild shortness of breath and/or angina) and slight limitation during ordinary activity.
Class III - Marked limitation in activity due to symptoms, even during less-than-ordinary activity, e.g. walking short distances (20-100 m).Comfortable only at rest.
Class IV - Severe limitations. Experiences symptoms even while at rest. Mostly bedbound patients.
Time Frame
12 Months
Title
Pacing thresholds.
Description
Pacing thresholds.
Time Frame
12 Months
Title
Total implantation and electrode implantation times.
Description
Total implantation and electrode implantation times.
Time Frame
12 Months
Title
Adverse events.
Description
Resulted in reintervention or the termination of significant device function
Time Frame
12 Months
Title
Six minute walking test.
Description
Six minute walking test.
Time Frame
12 Months
Title
The Quality of Life Scale.
Description
The Minnesota living with heart failure questionnaire. The most widely used health-related quality of life questionnaires for patients with heart failure. Values from 0 to 105 (more is worse).
Time Frame
12 Months
Title
NT-proBNP.
Description
NT-proBNP measure
Time Frame
12 Months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
The patient must be ≥ 18 years of age.
The patient must indicate their acceptance to participate in the study by signing an informed consent document.
Patients with EF> 50% and indication for pacemaker implantation due to atrial-ventricular block according to current clinical guidelines.
Exclusion Criteria:
Inability to understand and sign the informed consent.
Patients with severe comorbidities and life expectancy <1 year.
Patients with severe cognitive impairment or other comorbidities resulting in dependence for basic activities of daily life.
Patients who cannot come to our center to carry out the follow-up of the study.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lluís Mont, MD, PhD
Phone
+34 93 2271778
Email
lmont@clinic.cat
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jose M Tolosana, MD, PhD
Organizational Affiliation
Hospital Clinic of Barcelona
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Lluís Mont, MD, PhD
Organizational Affiliation
Hospital Clinic of Barcelona
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Margarida Pujol Lopez, MD
Organizational Affiliation
Hospital Clinic of Barcelona
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Clinic of Barcelona
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lluís Mont, MD PhD
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Physiological Pacing for AV Block to Prevent Pacemaker-induced Cardiomyopathy
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