NCT06499428

Brief Summary

The goal of this observational study is to learn about the effective ventricular pacing rate in follow-up of patients who underwent a pacemaker (PM) implantation after transcatheter aortic valve implantation (TAVI). Secondly the study want investigate possible conduction recovery in follow up of patients and possible predictive factors of different ventricular pacing rates.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
67

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Apr 2024

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 10, 2024

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

July 5, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 12, 2024

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 10, 2026

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 10, 2026

Completed
Last Updated

August 7, 2024

Status Verified

April 1, 2024

Enrollment Period

2 years

First QC Date

July 5, 2024

Last Update Submit

August 5, 2024

Conditions

Aortic StenosisConduction Defect, Cardiac

Outcome Measures

Primary Outcomes (1)

  • ventricular pacing rate

    1 year

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Data relating to all patients undergoing PM implantation will be collected in the days of hospitalization following TAVI surgery at our current institute (IRCCS Galeazzi Hospital - Sant'Ambrogio) between September 2022 and the closure of the study.

You may qualify if:

  • PM implantation following TAVI surgery, during the same hospitalization
  • Signature of informed consent
  • Over the age of 18.

You may not qualify if:

  • PM implantation prior to hospitalization for TAVI
  • PM implantation during hospitalization different from the hospitalization for TAVI
  • Pregnant or breastfeeding women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

IRCCS Ospedale GAleazzi-Sant'Ambrogio

Milan, 20132, Italy

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

brain natriuretic peptide

MeSH Terms

Conditions

Aortic Valve StenosisCardiac Conduction System Disease

Condition Hierarchy (Ancestors)

Aortic Valve DiseaseHeart Valve DiseasesHeart DiseasesCardiovascular DiseasesVentricular Outflow Obstruction

Study Officials

  • Michela Tarascio

    IRCCS Galeazzi Sant'Ambrogio

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

July 5, 2024

First Posted

July 12, 2024

Study Start

April 10, 2024

Primary Completion

April 10, 2026

Study Completion

June 10, 2026

Last Updated

August 7, 2024

Record last verified: 2024-04

Locations

IT(1)