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Physiologic Cardiac Pacing to Prevent Left Ventricular Dysfunction Post TAVI (PACE-4-TAVI)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05966675
Recruitment Status : Not yet recruiting
First Posted : August 1, 2023
Last Update Posted : August 8, 2023
Sponsor:
Collaborator:
Medical Research Agency, Poland
Information provided by (Responsible Party):
Medical University of Silesia

Study Description
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Brief Summary:
The study aims to compare permanent Conduction System Pacing (CSP) with the standard therapy - Right Ventricular Pacing (RVP) or Biventricular Pacing (BVP) - in preventing the development and progression of symptomatic Chronic Heart Failure (CHF) and improving survival in patients after Transcatheter Aortic Valve Implantation (TAVI).

Condition or disease Intervention/treatment Phase
Atrioventricular Block, Second and Third Degree Device: conduction system pacing Device: right ventricular or biventricular pacing Not Applicable

Detailed Description:
A multicenter randomized controlled head-to-head trial was planned to compare the effects of permanent pacemaker implantation (PPMI) using CSP (study intervention) with currently standard therapy - RVP or BVP (control group). The study population will consist of patients hospitalized after TAVI complicated with high-degree persistent atrioventricular (AV) block or newly developed complex AV or intraventricular conduction disturbances, qualified for PPMI within 30 days after surgery, following the 2021 European Society of Cardiology (ESC) guidelines on cardiac pacing and cardiac resynchronization therapy.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 500 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Patients will be randomized 1:1 to the intervention and control groups. In the control group, the type of ventricular pacing will depend on the left ventricular ejection fraction (LVEF): 1) RVP is planned in the group of patients with LVEF ≥40%, 2) BVP is planned in the group of patients with LVEF <40%, following current ESC guidelines.
Masking: Single (Participant)
Masking Description: Patient will be blind to type of intervention. Due to a need of method-specific use of hardware and tailored programming of cardiac devices, medical staff is impossible to blind. The inability to blind affects also echocardiographists and anyone performing device interrogation as significant differences in number and localisation of pacing leads, their electrical parameters and pacemaker settings are inherently different in studied arms.
Primary Purpose: Prevention
Official Title: Physiologic Cardiac Pacing to Prevent Left Ventricular Dysfunction Post Transcatheter Aortic Valve Implantation
Estimated Study Start Date : October 1, 2023
Estimated Primary Completion Date : May 2028
Estimated Study Completion Date : June 2028
Arms and Interventions
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Arm Intervention/treatment
Experimental: Conduction System Pacing
Patients who receive Conduction System Pacing in form of Left Bundle Branch Area Pacing or His Bundle Pacing.
 Device: conduction system pacing
Implantation of cardiac implantable electronic device (CIED) with conduction system pacing (left bundle branch area pacing or his bundle pacing).
Active Comparator: Standard Pacing Method
Patients who receive currently standard pacing method with exact type of ventricular pacing depending upon left ventricular ejection fraction (LVEF): right ventricular pacing in case of LVEF >= 40% or biventricular pacing if LVEF is determined to be less than 40%, as per current ESC guidelines.
 Device: right ventricular or biventricular pacing
Implantation of cardiac implantable electronic device with right ventricular or biventricular pacing according to left ventricular ejection fraction and current ESC guidelines.


Outcome Measures
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Primary Outcome Measures :
  1. Heart Failure Hospitalization [ Time Frame: 12 months ]
    Hospitalization due to heart failure as a main reason

  2. All-cause death [ Time Frame: 12 months ]
    Death from any cause


Secondary Outcome Measures :
  1. Change in exercise capacity [ Time Frame: 24 months ]
    Improvement or deterioration in exercise capacity assessed as a change of ≥1 New York Heart Association (NYHA) functional class or a change in 6-Minute Walk Test (6MWT) distance by 55m or more

  2. Response to Cardiac Resynchronization Therapy (CRT) [ Time Frame: 24 months ]
    Meeting the echocardiographic criteria of response to CRT defined as a decrease in Left Ventricular End Systolic Volume by ≥15% or an increase in Left Ventricular Ejection Fraction by ≥5% from the baseline values

  3. Pacing-Induced Cardiomyopathy (PICM) [ Time Frame: 24 months ]
    Pacing-related CHF meeting the echocardiographic criteria of PICM defined as a decrease in LVEF by >=10% to the absolute value of <50%

  4. Change in global longitudinal strain (GLS) [ Time Frame: 24 months ]
    An increase in GLS value of 20 absolute percentage points from baseline or an increase above -16%.

  5. Atrial Fibrillation (AF) episodes [ Time Frame: 24 months ]
    Occurrence of the first episode of AF in a patient with no previous history of atrial fibrillation (AF).

  6. Atrial High Rate Episodes (AHRE) in pacemaker recordings [ Time Frame: 24 months ]
    Occurrence or change of the burden of AHRE events in the records from the CIED.

  7. Change in the concentration of the N-terminal pro-brain natriuretic peptide (NT-proBNP) [ Time Frame: 24 months ]
    pl/mL

  8. Change in Quality of Life [ Time Frame: 24 months ]
    Assessed with Short Form Health Survey (SF-36): 0 to 100; low QoL to high QoL - better outcome.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. transcatheter aortic valve implantation (TAVI) in up to 30 days before qualification to pacemaker implantation
  2. Fulfilled criteria for permanent pacemaker implantation according do 2021 ESC guidelines
  3. Written informed consent
  4. Age of at least 18 years

Exclusion Criteria:

  1. Permanent pacemaker implantation before TAVI procedure
  2. The occurrence of conduction disturbances more than 30 days after TAVI procedure
  3. No written informed consent
  4. Inability to obtain informed consent from participant
  5. Predicted inability to obtain cooperation from patient during observation period
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05966675


Contacts
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Contact: Krzysztof S. Gołba, MD PhD +48 (32)359-88-93 krzysztof.golba@gmail.com
Contact: Tomasz Soral, MD tomasz.soral@gmail.com

Locations
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Poland
Medical University of Silesia in Katowice
Katowice, Poland
Contact: Krzysztof S. Gołba, MD PhD       k.golba@sum.edu.pl   
Contact: Tomasz Soral, MD       tomasz.soral@gmail.com   
Sub-Investigator: Danuta Łoboda, MD, PhD         
Sub-Investigator: Rafał Gardas, MD, PhD         
Sub-Investigator: Jolanta Biernat, MD, PhD         
Sub-Investigator: Grzegorz Jarosiński, MD, PhD         
Sub-Investigator: Tomasz Soral, MD         
Sponsors and Collaborators
Medical University of Silesia
Medical Research Agency, Poland
Investigators
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Study Chair: Krzysztof S. Gołba, MD PhD Silesian Medical University in Katowice
More Information
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Publications:

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Responsible Party: Medical University of Silesia
ClinicalTrials.gov Identifier: NCT05966675    
Other Study ID Numbers: 2022/ABM/03/00049
First Posted: August 1, 2023    Key Record Dates
Last Update Posted: August 8, 2023
Last Verified: June 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Medical University of Silesia:
Pacemaker
Transcatheter Aortic Valve Replacement
Conduction System Pacing (CSP)
 Atrioventricular Block
Congestive Heart Failure
Bradycardia
Additional relevant MeSH terms:
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Ventricular Dysfunction
Ventricular Dysfunction, Left
Atrioventricular Block
Heart Diseases
Cardiovascular Diseases
 Heart Block
Arrhythmias, Cardiac
Cardiac Conduction System Disease
Pathologic Processes