Atrial FibrillationAVA CONDUCTNCT07428967
AV Node Ablation and CONDUCTion System Pacing for Atrial Fibrillation With Preserved Left Ventricular Function
A study testing RV pacing and LBBA pacing in people with Atrial Fibrillation and Atrial Arrhythmia, run by St. Josefs-Hospital Wiesbaden GmbH at 2 sites in Germany.
Trial summary
AVA CONDUCT is a prospective, multicenter, randomized study with single blinding, comparing left bundle branch area (LBBA) pacing with right ventricular (RV) pacing following AV node ablation in terms of clinical, functional, and electrophysiological outcomes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation, Atrial Arrhythmia
- What is being tested?
- RV pacing and LBBA pacing
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 86 participants
- Where
- 2 sitesGermany
- Study dates
- 1 Feb 2026to 31 Dec 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- History of symptomatic AF (EHRA IIb - IV) despite guideline-indicated medical or interventional therapy
- Preserved LVEF (≥ 50%, assessed by echocardiography, Simpson's biplane method)
- AV node ablation scheduled independently of possible study participation
- Age ≥ 18 years
- Consent capacity
Who cannot join
- Impaired LVEF (< 50%)
- Pre-implanted pacemaker
- Contraindication for pacemaker implantation or AV node ablation (see chapter 5.3 for details)
- High grade (III°) left cardiac valvular disease
- Surgical coronary revascularization (within the last 30 days) or current triple therapy after stent PCI
- Body-mass-index > 40 kg/m2
Show all 9Show fewer
- Pregnancy
- Inability to give written informed consent
- Life expectancy < 12 months
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Germany2 sites, 2 recruiting
- Not yet recruiting
Evangelisches Krankenhaus Hagen-Haspe
Hagen
Harilaos Bogossian, MD
- Recruiting
St. Josefs-Hospital Wiesbaden GmbH
Wiesbaden
Joachim Ehrlich, MD, +496111771200, jehrlich@joho.de
Joachim Ehrlich, MD
About this study
Official title: AtrioVentricular Node Ablation and CONDUCTion System Pacing for Atrial Fibrillation With Preserved Left Ventricular Function - a Randomized Controlled Trial
AVA CONDUCT is a prospective, multicenter, randomized study with single blinding, comparing left bundle branch area (LBBA) pacing with right ventricular (RV) pacing following AV node ablation in terms of clinical, functional, and electrophysiological outcomes.
The primary hypothesis is that pacing-induced cardiomyopathy, defined as a decrease in LVEF by 10% or more from baseline to an absolute value below 50%, occurs significantly more frequently in patients receiving RV pacing compared with LBBA pacing. Secondarily, LBBA pacing is expected to maintain comparable procedural safety while providing better cardiac function, resulting in improved quality of life and functional capacity compared with conventional RV pacing.
- Conditions
- Atrial Fibrillation, Atrial Arrhythmia
- Being tested
- RV pacing, LBBA pacing
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RV pacingProcedure or surgery
RV apical pacemaker implantation prior to AV node ablation
LBBA pacingProcedure or surgery
LBBA pacemaker implantation prior to AV node ablation
| Study group | Role | What they receive |
|---|---|---|
| Right ventricular pacing | Active comparator | Not described Receives: Procedure: RV pacing |
| Left bundle branch area pacing | Active comparator | Not described Receives: Procedure: LBBA pacing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients developing pacemaker-induced cardiomyopathy
Echocardiographically detected deterioration in systolic LVEF of
≥10% to an absolute value of < 50%
Measured: 36 months
Secondary outcomes (14)
Left ventricular function
Left ventricular ejection fraction (%)
Measured: 36 months
Left Ventricular Global Longitudinal Strain
Global longitudinal strain of the left ventricle (%)
Measured: 36 months
Right ventricular function
Tricuspid Annular Plane Systolic Excursion (mm)
Measured: 36 months
Right ventricular function
Right Ventricle - Pulmonary Artery Coupling (mm/mmHg)
Measured: 36 months
Right ventricular function
Right ventricular strain (%)
Measured: 36 months
NT-proBNP serum concentration (ng/L)
NT-proBNP serum concentration (ng/L)
Measured: 36 months
Quality of life assessed using the EuroQol 5-Dimension 5-Level (EQ-5D-5L) index score
Ranging from 0 to 100 with higher scores represent a better outcome.
Measured: 36 months
6-minute walk distance (meters)
Measured: 36 months
All-cause mortality
Measured: 36 months
Number of patients with a rehospitalization due to heart failure/cardiac decompensation
Measured: 36 months
Number of patients with a rehospitalization due to pacemaker malfunction
Measured: 36 months
Number of patients with a rehospitalization due to atrial arrhythmia
Measured: 36 months
Number of patients experiencing a stroke or transient ischemic attack
Measured: 36 months
Procedure-related complications
Number of patients with one of the following events: death, stroke and TIA; clinically relevant bleeding (Bleeding Academic Research Consortium ≥2) including hematoma at the pacemaker pocket prolonging hospital stay; thrombosis of subclavian/axillary/cubital vein; pneumothorax, pericardial effusion and tamponade; myocardial or septal perforation; coronary vessel injury, including fistula formation; pacemaker lead dislocation or perforation; infection, including pacemaker pocket infection, lead infection, and pacemaker-associated endocarditis; treatment-requiring groin complications such as aneurysm, AV fistula, or dissection (prolonging hospital stay)
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2026
- Study start1 Feb 2026
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Single blind
- Who is masked
- Participant
- Enrolment
- 86 participants (estimated)
Sponsor and investigators
- Lead sponsor
- St. Josefs-Hospital Wiesbaden GmbH
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07428967
- Sponsor's protocol ID
- AVA CONDUCT
- Acronym
- AVA CONDUCT
- Status last verified
- Feb 2026
- First submitted
- 6 Feb 2026
- Last updated
- 24 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- AtrioVentricular Node Ablation and CONDUCTion System Pacing for Atrial Fibrillation With Preserved Left Ventricular Function - a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07428967
- Acronym / sponsor ID
- AVA CONDUCT / AVA CONDUCT
- Conditions
- Atrial Fibrillation, Atrial Arrhythmia
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 86 participants (estimated)
- Lead sponsor
- St. Josefs-Hospital Wiesbaden GmbHUniversity, hospital or other
- Study start
- 1 Feb 2026 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 24 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
AVA CONDUCT is a prospective, multicenter, randomized study with single blinding, comparing left bundle branch area (LBBA) pacing with right ventricular (RV) pacing following AV node ablation in terms of clinical, functional, and electrophysiological outcomes.
The primary hypothesis is that pacing-induced cardiomyopathy, defined as a decrease in LVEF by 10% or more from baseline to an absolute value below 50%, occurs significantly more frequently in patients receiving RV pacing compared with LBBA pacing. Secondarily, LBBA pacing is expected to maintain comparable procedural safety while providing better cardiac function, resulting in improved quality of life and functional capacity compared with conventional RV pacing.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Right ventricular pacing | Active comparator | Procedure: RV pacing |
| Left bundle branch area pacing | Active comparator | Procedure: LBBA pacing |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- History of symptomatic AF (EHRA IIb - IV) despite guideline-indicated medical or interventional therapy
- Preserved LVEF (≥ 50%, assessed by echocardiography, Simpson's biplane method)
- AV node ablation scheduled independently of possible study participation
- Age ≥ 18 years
- Consent capacity
Key exclusion criteria (9 listed)
- Impaired LVEF (< 50%)
- Pre-implanted pacemaker
- Contraindication for pacemaker implantation or AV node ablation (see chapter 5.3 for details)
- High grade (III°) left cardiac valvular disease
- Surgical coronary revascularization (within the last 30 days) or current triple therapy after stent PCI
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RV pacingRV apical pacemaker implantation prior to AV node ablation | Procedure or surgery | Right ventricular pacing |
| LBBA pacingLBBA pacemaker implantation prior to AV node ablation | Procedure or surgery | Left bundle branch area pacing |
Primary outcome
Number of patients developing pacemaker-induced cardiomyopathy
Time frame: 36 months
Echocardiographically detected deterioration in systolic LVEF of ≥10% to an absolute value of < 50%
14 secondary outcomes
Left ventricular function
Time frame: 36 months
Left Ventricular Global Longitudinal Strain
Time frame: 36 months
Right ventricular function
Time frame: 36 months
Right ventricular function
Time frame: 36 months
Right ventricular function
Time frame: 36 months
NT-proBNP serum concentration (ng/L)
Time frame: 36 months
Quality of life assessed using the EuroQol 5-Dimension 5-Level (EQ-5D-5L) index score
Time frame: 36 months
6-minute walk distance (meters)
Time frame: 36 months
All-cause mortality
Time frame: 36 months
Number of patients with a rehospitalization due to heart failure/cardiac decompensation
Time frame: 36 months
Number of patients with a rehospitalization due to pacemaker malfunction
Time frame: 36 months
Number of patients with a rehospitalization due to atrial arrhythmia
Time frame: 36 months
Number of patients experiencing a stroke or transient ischemic attack
Time frame: 36 months
Procedure-related complications
Time frame: 36 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RV pacing and LBBA pacing in people with Atrial Fibrillation and Atrial Arrhythmia, run by St. Josefs-Hospital Wiesbaden GmbH at 2 sites in Germany.
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 5 inclusion and 9 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: looking for participants now, as of the sponsor's last update on 24 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients developing pacemaker-induced cardiomyopathy (time frame: 36 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Feb 2026.