Pacing to Maintain Physiologic Ventricular Activation

NCT04416958 | Recruiting

• 1 other identifier: Pace_Cond_KHF
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

Right ventricular pacing causes ventricular dyssynchrony and may be associated with impaired outcome. In the last decade, several approaches for more physiological pacing became available and were implemented in the latest guidelines. However, compared to conventional device implantation, cardiac resynchronization, His bundle pacing and left bundle area pacing remain demanding procedures in the individual case. Goal of the single center observational "Pace conduct" study is to evaluate implantation success, safety and outcome of pacing methods that maintain physiologic ventricular activation.

Conditions

Pacemaker DDD; His Bundle Pacing; LBB Area Pacing; Pacing-Induced Cardiomyopathy; Left Bundle-Branch Block; ICD

Keywords

His bundle pacing; LBB area pacing; cardiac resynchronisation therapy

Outcome Measures

Primary Outcomes (1)

• CIED Implantation success

  successful Pacemaker- or ICD implantation with effective pacing and acceptable pacing threshold in the targeted area

  peri-procedural

Secondary Outcomes (5)

• pre-operative: Implantation related Patient characteristics

  1 month post implantation

• intra-procedural: implant success related with procedural characteristics

  peri-procedural

• peri-procedural: safety and radiation

  peri-procedural

• follow-up: device function

  one year

• follow-up: outcome

  one year

Study Arms (1)

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.

Device: cardiac implantable electronic device (CIED) implantation

Interventions

cardiac implantable electronic device (CIED) implantation DEVICE

CIED Implantation according to the Guidelines aiming to avoid pacing induced dyssynchrony

CIED for cardiac resynchronisation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• Pacemaker or ICD Implantation aiming to avoid pacing induced ventricular dyssynchrony according to current guidelines
• age \>= 18 years

You may not qualify if:

• no informed consent for the procedure given
• no follow-up data

Sponsors & Collaborators

• Klinikum-Fuerth: lead
• University of Erlangen-Nürnberg: collaborator
• University of Trieste: collaborator

Study Sites (1)

Klinikum Fuerth

Fürth, Bavaria, 90766, Germany

RECRUITING

Related Publications (1)

• Bastian D, Gregorio C, Buia V, Walaschek J, Rittger H, Vitali-Serdoz L. His bundle pacing guided by automated intrinsic morphology matching is feasible in patients with narrow QRS complexes. Sci Rep. 2022 Mar 4;12(1):3606. doi: 10.1038/s41598-022-07516-6.

  PMID: 35246595 DERIVED

MeSH Terms

Conditions

Bundle-Branch Block

Condition Hierarchy (Ancestors)

Heart Block; Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Cardiac Conduction System Disease; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Dirk Bastian, MD

  Klinikum-Fuerth

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dirk Bastian, MD

CONTACT

+49 911 7580 1101; dirk.bastian@klinikum-fuerth.de

Laura Vitali-Serdoz, MD

CONTACT

+49 911 7580 1101; laura.vitali-serdoz@klinikum-fuerth.de

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 1, 2020
• First Posted: June 4, 2020
• Study Start: January 1, 2018
• Primary Completion: December 31, 2025
• Study Completion (Estimated): December 31, 2030
• Last Updated: October 15, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)