Resynchronization in Patients With HF in AF Trial Undergoing Pace & AVNA Strategy With LBBAP Compared With BiV Pacing (RAFT-P&A)

June 5, 2024 updated by: Habib Khan

Resynchronization in Patients With Ambulatory Heart Failure in Atrial Fibrillation Trial Undergoing Pace and Atrioventricular Node Ablation Strategy With Left Bundle Branch Area Pacing Compared With Biventricular Pacing

This trial will compare two management strategies for HF patients with Atrial Fibrillation. The active control group will undergo BiV pacing, followed by an AV node ablation. The experimental group will undergo LBBAP, followed by an AV node ablation.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This is a prospective, randomized, double blind, control trial with follow up visits at 6- and 12-months following randomization. Patients will be randomized in a 1:1 allocation to either the control group [optimal medical therapy (OMT) + CRT + ANVA] or the treatment group [OMT + LBBAP + ANVA]. Randomization will be stratified by site and LVEF. In each group, the patient will undergo the pacing procedure (CRT or LBBAP) within 10 working days of randomization. They will be assessed by a physician one week after the CRT procedure, and if eligible, they will undergo an AVNA within 1-4 weeks. Success of these treatment plans will be evaluated primarily based on the change in NT-proBNP from baseline to 6- and 12-month follow ups. At baseline and follow up visits study staff and physicians will collect participants' medical history, complete a Physical Exam and an NYHA Class Assessment, a medication assessment, and a 6 Minute Walk Test. Participants will also be asked to complete Quality of Life Questionnaires (Minnesota Living with Heart Failure Questionnaire (MLHFQ) score, KCCQ and EQ-5D-5L), have an ECG and TTE performed if they have not had one performed recently, non- invasive hemodynamic measurements (if available), and complete routine bloodwork and an NT-proBNP test. The adequacy of HF treatment will be assessed clinically, and medications optimized and recorded. Device diagnostics will be assessed and recorded as to whether there are arrhythmias and to determine the appropriateness of device programming. Secondary study outcomes include QoL scores (MLHFQ, KCCQ and EQ-5D), as well as 6MWT distance, and change in echocardiogram parameters (including change in LVESV index from baseline, change in global longitudinal LV systolic strain from baseline, and change in LVEF from baseline at 6-month and 12-month followup). Secondary outcomes also include radiation exposure between LBBAP and CRT, feasibility of achieving conduction system pacing with LBBAP compared to CRT, and acute and long-term hemodynamic change due to either CRT or LBBAP (i.e., non-invasive hemodynamic measurements before and after AV node ablation including systolic BP, diastolic BP, cardiac output, stroke volume, total peripheral resistance, and pulse pressure).

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
284

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Canada
    • Ontario
      • London, Ontario, Canada
        • London Health Sciences Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Patients with atrial fibrillation (AF) where AVNA is being considered with or without a pacemaker

    1. Are on optimal heart failure therapies for ≥4 weeks
    2. NYHA class I-IVa

  2. Patients deemed not appropriate for rhythm control strategy (only for rate control strategy).

    1. Failed Ablation (≥1 failed ablation attempt)
    2. Refractory or intolerant to Antiarrhythmic drugs AADs or rate control medications
    3. Patient choice not to have rhythm control strategies
    4. Being considered for AVNA
  3. Patients with baseline NT-proBNP>600 or >400 if HF hospitalization within 12 months.

Exclusion Criteria:

  1. In-hospital patients with acute cardiac or non-cardiac illness that requires intensive care
  2. Acute coronary syndrome (including MI) or Coronary revascularization (CABG or PCI) <3 months
  3. Uncorrected or uncorrectable primary moderate to severe valvular disease
  4. TAVI < 3 months
  5. Restrictive, or reversible form of cardiomyopathy, cardiac amyloidosis
  6. Severe primary pulmonary disease such as cor pulmonale, irreversible lung disease requiring inhalers, oxygen supplementation
  7. Pulmonary hypertension (Mean pulmonary pressure is ≥35 mm Hg)
  8. Patients with a life expectancy of less than one year from non-cardiac cause
  9. Patients included in other clinical trials that will affect the objectives of this study or have competing interests
  10. Those unable or unwilling to provide informed consent unless supported by legal power of attorney
  11. Active malignancy with likelihood of survival <1 year
  12. NYHA class IVb

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Cardiac Resynchronization Therapy + AV node ablation
The active comparator group will be treated with CRT followed by an Atrioventricular Node Ablation.
Procedure: CRT
The patients will be allocated by randomization to receive the intervention of CRT.
Procedure: AV node ablation
AV node ablation after 4 weeks of CRT implant or LBBAP implant.
Experimental: Left Bundle Branch Area Pacing + AV node ablation
The experimental group will be treated with LBBAP followed by an Atrioventricular Node Ablation.
Procedure: AV node ablation
AV node ablation after 4 weeks of CRT implant or LBBAP implant.
Procedure: Left Bundle Branch Area Pacing
The patients will be allocated by randomization to receive the intervention of Left Bundle Branch Area Pacing
Other Names:
  • LBBAP

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in NT-proBNP from baseline to 6-month follow-up
Time Frame: baseline and 6 months
Comparison between NT-proBNP measurement at baseline and 6-month follow-up
baseline and 6 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Event rates of the composite outcome of heart failure events and all-cause mortality
Time Frame: 12 months
HF and mortality data will be collected throughout the duration of the study
12 months
Change in QoL - MLHFQ
Time Frame: baseline, 6 months and 12 months
The Minnesota Living with Heart Failure Questionnaire (MLHFQ) score is used to measure quality of life. The MLHFQ consists of 21 questions answered on a 0-5 likert scale, with higher scores indicating a stronger impact of heart failure on QoL.
baseline, 6 months and 12 months
Change in QoL - KCCQ
Time Frame: baseline, 6 months and 12 months
Cardiomyopathy Questionnaire (Kansas City) (KCCQ-12) measures how heart failure impacts a patient's quality of life. The questionnaire measures frequency and burden of heart failure symptoms as well as physical and social limitations related to heart failure using a likert scale of 0-100, with higher scores indicating better health.
baseline, 6 months and 12 months
Change in QoL - EQ-5D
Time Frame: baseline, 6 months and 12 months
EuroQol- 5 Dimension measures health related quality of life using a Level 1-5 component scale. A lower score indicates better health related quality of life. The EQ-5D also contains the EQ VAS, a 0-100 self reported scale where 100 indicates best health imaginable.
baseline, 6 months and 12 months
Change 6MWT distance
Time Frame: baseline, 6 months and 12 months
Change in distance walked in the 6MWT from baseline to 6-month and 12-month follow-up
baseline, 6 months and 12 months
Change in echocardiogram parameters - Left Ventricular End Systolic Volume index (LVESVi)
Time Frame: baseline, 6 months and 12 months
Compared from baseline to 6-month and 12-month follow-up. A lower LVESVi indicates a trend towards normal volumes and a higher LVESVi indicates ventricle dilation compared to the normal population.
baseline, 6 months and 12 months
Change in echocardiogram parameters - Left Ventricle (LV) Global Longitudinal strain
Time Frame: baseline, 6 months and 12 months
Compared from baseline to 6-month and 12-month follow-up. A lower LV Global Longitudinal strain indicates stronger left ventricular contraction.
baseline, 6 months and 12 months
Change in echocardiogram parameters - Left Ventricular Ejection Fraction (LVEF)
Time Frame: baseline, 6 months and 12 months
Compared from baseline to 6-month and 12-month follow-up. An increase in LVEF indicates stronger function of the left ventricle.
baseline, 6 months and 12 months
Radiation exposure at device implant
Time Frame: During Surgical Intervention
Exposure time collected at device implant visits
During Surgical Intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Habib Khan

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
London Health Sciences Centre

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Habib Khan, MBBS, PhD, London Health Sciences Centre

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 26, 2022

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 31, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 10, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 17, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 23, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 7, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 5, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 3819

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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