- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04416958
Pacing to Maintain Physiologic Ventricular Activation (Pace-Conduct)
Pacing for Cardiac Resynchronisation Using the Intrinsic Conduction System to Maintain Physiologic Ventricular Activation
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Background:
Conventional ectopic myocardial right ventricular pacing (RVP) causes ventricular dyssynchrony and may be associated with reverse ventricular remodeling, reduced ejection fraction (EF), left ventricular dilatation, functional mitral valve regurgitation, heart failure and an increased rate of new onset atrial fibrillation.
Dependent on individual patient's characteristics, several strategies are established to prevent and to overcome the potential drawbacks of chronic RVP. In general, unnecessary ectopic RVP should be avoided. For example, in patients with sinus node disease and intact atrioventricular (AV) conduction, atrial pacing, AV (search) hysteresis or AAI-DDD/ADI pacing may be used. In patients with impaired cardiac function and an expected higher percentage of RVP, pacing strategies for cardiac resynchronization are indicated. Conventional cardiac resynchronization therapy (CRT) uses an additional transvenous left ventricular lead for synchronous ventricular stimulation and was shown to shorten QRS duration and to reduce morbidity and mortality in patients with chronic heart failure, left bundle branch block (LBBB) and reduced EF. Due to the non-physiological left ventricular epicardial stimulation, however, conventional CRT is associated with 30% of non-responders and may even prolong ventricular activation in patients with narrower QRS complex. First described in 1968, His bundle pacing (HBP) has evolved to an increasingly used alternative for cardiac pacing. Currently, HBP is regarded the most physiologic approach for ventricular stimulation because it prevents ventricular dyssynchrony and its potential fatal long-term consequences by preserving normal electrical activation of the ventricles. Clinical benefit of HBP has been shown compared with conventional permanent RVP and CRT. Recent studies documented restoration of normal electrical and mechanical left ventricular synchrony for both selective and non-selective HBP. However, compared with conventional RVP the implantation procedure for HBP is much more demanding requiring exact placement of the pacing lead within the anatomically variable His bundle area. Alternatively, the correction of bundle branch conduction disorders has been demonstrated for left bundle branch area (LBBA) pacing. As a consequence, current guidelines recommend pacing methods that maintain physiologic ventricular activation in patients with atrioventricular block who have an indication for permanent pacing with a LVEF between 36% and 50% and are expected to require ventricular pacing more than 40% of the time (class IIa indication).
In summary, there is increasing evidence showing the benefits of the different strategies for physiologic pacing but the appropriate use of these approaches may be challenging in the individual case. Therefore, appropriate patient selection, implantation approaches, device programming and follow-up require further intensive evaluation.
Objective:
Main goal of the study is to evaluate implantation success for pacing methods aiming to maintain physiologic ventricular activation. Procedural success is defined as stable lead positioning and effective pacing within the target area with an appropriate and stable pacing threshold.
Secondary goals of the study are to document and to evaluate
- procedural parameters (e.g. venous access, time needed for lead implant, procedural duration, radiation) and adverse events dependent on procedural approaches and patients characteristics,
- performance of the implanted system (sensing, pacing thresholds) and clinical outcome during routine follow-up
Study design:
Single center, non-randomized, observational study, retrospective data analysis, on-going prospective patient enrollment, descriptive statistics.
Center: Klinikum Fuerth (Dept. for Heart and Lung diseases, section for clinical electrophysiology) / Germany in cooperation with the Dept. of Cardiology of the University Erlangen / Germany and the University of Trieste / Italy.
Patients and methods:
Primary endpoint: Implantation success. Effective pacing and acceptable pacing threshold at the targeted lead position. Target for lead placement is the area with maximum delayed ventricular activation for transvenous CRT, the His bundle for selective or non-selective HBP and the right interventricular septum with left bundle branch capture for LBBA pacing, respectively. Target thresholds for the lead placed within the coronary sinus or at the intrinsic conduction system is <2.5 V @ 1 ms with a maximum acceptable threshold of <4.0 V @ 2 ms or <5 V @ 1 ms. Target for all other leads is <1 V @ 0.5 ms.
Secondary endpoints: patient characteristics and association with outcome. Implantation success and outcome correlated with patient characteristics including electrocardiogram and echocardiographic parameter and procedure related techniques and parameter. Safety: radiation exposure, number and type of adverse events and adverse device related events. Follow-up: device function, interrogation, programming and clinical outcome as evaluated in routine follow-up, incl. ECG, echocardiography and parameter for assessment of heart failure. Subpopulations: managed ventricular pacing, His bundle pacing, LBB-area pacing, CRT. Implantation with or without electroanatomic mapping system.
Inclusion criteria:
Implantation of a pacemaker or ICD according to the current guidelines (Class I or IIa indication) aiming to avoid pacing induced dyssynchrony, e.g. managed ventricular pacing, His-bundle pacing, LBB-area pacing or conventional transvenous CRT. Age ≥ 18 years.
Exclusion criteria:
No given informed consent for the procedure. No follow up data available.
Sample size:
For the observational study, there is no pre-specified sample-size. Data from 200 patients and procedures are expected.
Data security:
Study related data are collected by the study investigators in an anonymous clinic-internal data-base that is password protected. All investigators have to provide valid GCP training.
Risk estimation:
The study is observational and descriptive with anonymized data collection and data analysis. Therefore, the study adds no risk to the study population.
Ethics:
The "Pace-Conduct" study has been approved by the responsible ethics committee of the Friedrich- Alexander University Erlangen, Germany (145_20 Bc)
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Dirk Bastian, MD
- Phone Number: +49 911 7580 1101
- Email: dirk.bastian@klinikum-fuerth.de
Study Contact Backup
- Name: Laura Vitali-Serdoz, MD
- Phone Number: +49 911 7580 1101
- Email: laura.vitali-serdoz@klinikum-fuerth.de
Study Locations
-
-
Bavaria
-
Fuerth, Bavaria, Germany, 90766
- Recruiting
- Klinikum Fuerth
-
Contact:
- Dirk Bastian, MD
- Phone Number: +49 (0)911 7580 1101
- Email: dirk.bastian@klinikum-fuerth.de
-
Contact:
- Laura Vitali-Serdoz, MD
- Phone Number: +49 (0)911 7580 1101
- Email: laura.vitali-serdoz@klinikum-fuerth.de
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Patients undergoing Pacemaker or ICD Implantation according to current Guidelines with the aim to avoid pacing induced ventricular dyssynchrony.
Subgroups according to type of device implanted, lead Position and programming.
Description
Inclusion Criteria:
- Pacemaker or ICD Implantation aiming to avoid pacing induced ventricular dyssynchrony according to current guidelines
- age >= 18 years
Exclusion Criteria:
- no informed consent for the procedure given
- no follow-up data
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
CIED for cardiac resynchronisation
Patients implanted with an CIED for cardiac resynchronisation aiming to avoid pacing induced ventricular dyssynchrony, e.g.
His bundle pacing, LBB-area pacing, CRT.
These different implanted types of devices may be further analysed as subgroups.
|
CIED Implantation according to the Guidelines aiming to avoid pacing induced dyssynchrony
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
CIED Implantation success
Time Frame: peri-procedural
|
successful Pacemaker- or ICD implantation with effective pacing and acceptable pacing threshold in the targeted area
|
peri-procedural
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
pre-operative: Implantation related Patient characteristics
Time Frame: 1 month post implantation
|
association with procedural and post-implant outcome
|
1 month post implantation
|
intra-procedural: implant success related with procedural characteristics
Time Frame: peri-procedural
|
correlation of Implantation success with Patient characteristics and procedural technical Parameter, eg.
use of an electroanatomic mapping system
|
peri-procedural
|
peri-procedural: safety and radiation
Time Frame: peri-procedural
|
Radiation exposure and number and type of all adverse Events and adverse device associated events
|
peri-procedural
|
follow-up: device function
Time Frame: one year
|
device parameter and programming during follow up
|
one year
|
follow-up: outcome
Time Frame: one year
|
clinical Outcome during follow up
|
one year
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Dirk Bastian, MD, Klinikum-Fuerth
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Pace_Cond_KHF
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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