Does Permanent Pacemaker Status Confer Mortality Benefit... | NCT02700633

Studies
Does Permanent Pacemaker Status Confer Mortality Benefit in the Short Term Post TAVI

NCT02700633

Sponsor

Royal Sussex County Hospital

Status

Unknown status

Last Update Posted

Mar 7, 2016Estimated

Enrollment

4,000Actual

Phase

Not provided

Conditions

TAVI

Interventions

Pacemaker

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2016

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2016

Primary Completion Date

Jul 2016Estimated

Completion Date

Not provided

First Submitted Date

Mar 2, 2016

First Submission Date that Met QC Criteria

Mar 2, 2016

First Posted Date

Mar 7, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 2, 2016

Last Update Posted Date

Mar 7, 2016Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

David Hildick-Smith, Consultant Cardiologist, Royal Sussex County HospitalPrincipal Investigator

Lead Sponsor

Royal Sussex County HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Pacemaker requirement in the immediate post procedure phase following TAVI is approximately 20% depending on device type and patient characteristics. There is a signal from recent studies suggesting increased risk of sudden cardiac / unexplained death in the first 30-60 days. This study aims to address whether there is a mortality advantage to having a pacemaker in the short term

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

4,000Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Those with pacemaker at discharge		Landmark analysis of early mortality dependant on pacemaker status at discharge	Device: Pacemaker
Those without pacemaker at discharge		Landmark analysis of early mortality dependant on pacemaker status at discharge

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Pacemaker	Device		Those with pacemaker at discharge

Measure	Description	Time Frame
30 day mortality		30 dyas

Measure	Description	Time Frame
60 day mortality		60 days

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

All patients post TAVI

Exclusion Criteria:

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

All patients post TAVI

Sampling Method

Non-Probability Sample