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Atrial FibrillationRAFT-P&ANCT05428787

Resynchronization in Patients With HF in AF Trial Undergoing Pace & AVNA Strategy With LBBAP Compared With BiV Pacing

A study testing Left Bundle Branch Area Pacing, CRT and AV node ablation in people with Atrial Fibrillation and Heart Failure, run by Habib Khan at 1 site in Canada.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 90 years
What is being tested?
Left Bundle Branch Area Pacing, CRT and AV node ablation
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
284 participants
Where
1 siteCanada
Study dates
26 Sep 2022to 31 Dec 2024
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 18 to 90 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients with atrial fibrillation (AF) where AVNA is being considered with or without a pacemaker
  • Are on optimal heart failure therapies for ≥4 weeks
  • NYHA class I-IVa
  • Patients deemed not appropriate for rhythm control strategy (only for rate control strategy).
  • Failed Ablation (≥1 failed ablation attempt)
  • Refractory or intolerant to Antiarrhythmic drugs AADs or rate control medications
Show all 9Show fewer
  • Patient choice not to have rhythm control strategies
  • Being considered for AVNA
  • Patients with baseline NT-proBNP>600 or >400 if HF hospitalization within 12 months.

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • London Health Sciences Centre

    London, Ontario

Other trials in Canada

About this study

Official title: 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.

Read the 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).

Being tested
Left Bundle Branch Area Pacing, CRT, AV node ablation
Keywords
LBBAP, Conductions system pacing, atrial fibrillation, pace and ablate, AV node ablation, CRT, BiV-CRT
Medical subject headings
Atrial Fibrillation, Heart Failure, Cardiomyopathies

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Left Bundle Branch Area PacingProcedure or surgery

    Also called LBBAP

    The patients will be allocated by randomization to receive the intervention of Left Bundle Branch Area Pacing

  • CRTProcedure or surgery

    The patients will be allocated by randomization to receive the intervention of CRT.

  • AV node ablationProcedure or surgery

    AV node ablation after 4 weeks of CRT implant or LBBAP implant.

Study groups in NCT05428787
Study groupRoleWhat they receive
Cardiac Resynchronization Therapy + AV node ablationActive comparatorThe active comparator group will be treated with CRT followed by an Atrioventricular Node Ablation.
Receives: Procedure: CRT; Procedure: AV node ablation
Left Bundle Branch Area Pacing + AV node ablationExperimentalThe experimental group will be treated with LBBAP followed by an Atrioventricular Node Ablation.
Receives: Procedure: Left Bundle Branch Area Pacing; Procedure: AV node ablation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in NT-proBNP from baseline to 6-month follow-up

    Comparison between NT-proBNP measurement at baseline and 6-month follow-up

    Measured: baseline and 6 months

Secondary outcomes (9)

  1. Event rates of the composite outcome of heart failure events and all-cause mortality

    HF and mortality data will be collected throughout the duration of the study

    Measured: 12 months

  2. Change in QoL - MLHFQ

    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.

    Measured: baseline, 6 months and 12 months

  3. Change in QoL - KCCQ

    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.

    Measured: baseline, 6 months and 12 months

  4. Change in QoL - EQ-5D

    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.

    Measured: baseline, 6 months and 12 months

  5. Change 6MWT distance

    Change in distance walked in the 6MWT from baseline to 6-month and 12-month follow-up

    Measured: baseline, 6 months and 12 months

  6. Change in echocardiogram parameters - Left Ventricular End Systolic Volume index (LVESVi)

    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.

    Measured: baseline, 6 months and 12 months

  7. Change in echocardiogram parameters - Left Ventricle (LV) Global Longitudinal strain

    Compared from baseline to 6-month and 12-month follow-up. A lower LV Global Longitudinal strain indicates stronger left ventricular contraction.

    Measured: baseline, 6 months and 12 months

  8. Change in echocardiogram parameters - Left Ventricular Ejection Fraction (LVEF)

    Compared from baseline to 6-month and 12-month follow-up. An increase in LVEF indicates stronger function of the left ventricle.

    Measured: baseline, 6 months and 12 months

  9. Radiation exposure at device implant

    Exposure time collected at device implant visits

    Measured: During Surgical Intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Jun 2022
  2. Study start26 Sep 2022
  3. Primary completion31 Jul 2024 (estimated)
  4. Study completion31 Dec 2024 (estimated)

Resources

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
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
284 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05428787
Sponsor's protocol ID
3819
Acronym
RAFT-P&A
Status last verified
Jun 2024
First submitted
10 May 2022
Last updated
7 Jun 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Left Bundle Branch Area Pacing, CRT and AV node ablation in people with Atrial Fibrillation and Heart Failure, run by Habib Khan at 1 site in Canada.

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 9 inclusion and 12 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: status not confirmed, as of the sponsor's last update on 7 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. 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?

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?

Change in NT-proBNP from baseline to 6-month follow-up (time frame: baseline and 6 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 NCT05428787.

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 7 Jun 2024.

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