Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621001700820
Ethics application status
Approved
Date submitted
23/10/2021
Date registered
13/12/2021
Date last updated
15/11/2022
Date data sharing statement initially provided
13/12/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
High-Grade Atrioventricular CONDUCTion Block After Transcatheter Aortic Valve Implantation (CONDUCT TAVI)
Scientific title
Prospective observational study on the accuracy of predictors of high-grade atrioventricular CONDUCTion block after Transcatheter Aortic Valve Implantation (CONDUCT TAVI)
Secondary ID [1] 305595 0
Nil known
Universal Trial Number (UTN)
Trial acronym
CONDUCT TAVI
Linked study record

Health condition
Health condition(s) or problem(s) studied:
High grade atrioventricular block 324022 0
Transcatheter Aortic Valve Implantation 324024 0
Permanent pacemaker 324049 0
Condition category
Condition code
Cardiovascular 321529 321529 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
This study will investigate the factors associated with high grade atrioventricular block (HGAVB) occurring up to 24 months after Transcatheter Aortic Valve Implantation (TAVI). Electrophysiology testing (including AV Wenckebach and HV interval measurement) will be performed immediately prior to and after TAVI deployment. All patients who do not require insertion of a permanent pacemaker during their admission will receive an implantable loop recorder (which is part of the study, additional to standard of care, and will remain implanted after the study unless there is an indication for removal). Patients will be followed up at 28 days, 3 months, 6 months, 12 months and 24 months for loop recorder / pacemaker interrogation, ECG, TTE and medical review.
Intervention code [1] 321995 0
Not applicable
Comparator / control treatment
No control group.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 329298 0
The sensitivity, specificity, positive predictive value and negative predictive value of a 50 ms increase in the AV Wenkebach cycle length after TAVI to detect HGAVB (as detected by ECG, cardiac telemetry or implantable loop recorder)
Timepoint [1] 329298 0
TAVI admission, 28 days, 6 months, 12 months and 24 months
Primary outcome [2] 329617 0
The sensitivity, specificity, positive predictive value and negative predictive value of a 50 ms increase in the AV Wenkebach cycle length and a 13 ms increase in the HV interval after TAVI to detect HGAVB (as detected by ECG, cardiac telemetry or implantable loop recorder)
Timepoint [2] 329617 0
TAVI admission, 28 days, 6 months, 12 months and 24 months
Primary outcome [3] 329618 0
The sensitivity, specificity, positive predictive value and negative predictive value of a 13 ms increase in the HV interval after TAVI to detect HGAVB (as detected by ECG, cardiac telemetry or implantable loop recorder)
Timepoint [3] 329618 0
TAVI admission, 28 days, 6 months, 12 months and 24 months
Secondary outcome [1] 402050 0
Primary Outcome:
The sensitivity, specificity, positive predictive value and negative predictive value of AV Wenckebach at a cycle length >= 500 ms immediately after TAVI to detect HGAVB (as detected by ECG, cardiac telemetry or implantable loop recorder)
Timepoint [1] 402050 0
TAVI Admission, 28 days, 6 months, 12 months, 24 months
Secondary outcome [2] 402156 0
Primary Outcome:
The sensitivity, specificity, positive predictive value and negative predictive value of AV Wenckebach at a cycle length >= 500 ms immediately before TAVI to detect HGAVB (as detected by ECG, cardiac telemetry or implantable loop recorder)
Timepoint [2] 402156 0
TAVI Admission, 28 days, 6 months, 12 months, 24 months
Secondary outcome [3] 402157 0
Primary Outcome:
The sensitivity, specificity, positive predictive value and negative predictive value of HGAVB during TAVI to detect HGAVB (as detected by ECG, cardiac telemetry or implantable loop recorder)
Timepoint [3] 402157 0
TAVI Admission, 28 days, 6 months, 12 months, 24 months
Secondary outcome [4] 403179 0
Primary Outcome:
The sensitivity, specificity, positive predictive value and negative predictive value of right bundle branch block as detected by ECG to detect HGAVB (as detected by ECG, cardiac telemetry or implantable loop recorder).
Timepoint [4] 403179 0
immediately prior, immediately post, 4 hours post and 24 hours post TAVI
Secondary outcome [5] 403180 0
Primary Outcome:
The sensitivity, specificity, positive predictive value and negative predictive value of left bundle branch block as detected by ECG to detect HGAVB (as detected by ECG, cardiac telemetry or implantable loop recorder).
Timepoint [5] 403180 0
immediately prior, immediately post, 4 hours post and 24 hours post TAVI
Secondary outcome [6] 403181 0
Primary Outcome:
The sensitivity, specificity, positive predictive value and negative predictive value of left anterior hemiblock as detected by ECG to detect HGAVB (as detected by ECG, cardiac telemetry or implantable loop recorder).
Timepoint [6] 403181 0
immediately prior, immediately post, 4 hours post and 24 hours post TAVI
Secondary outcome [7] 403182 0
Primary Outcome:
The sensitivity, specificity, positive predictive value and negative predictive value of left posterior hemiblock as detected by ECG to detect HGAVB (as detected by ECG, cardiac telemetry or implantable loop recorder).
Timepoint [7] 403182 0
immediately prior, immediately post, 4 hours post and 24 hours post TAVI
Secondary outcome [8] 403183 0
Primary Outcome:
The sensitivity, specificity, positive predictive value and negative predictive value of first degree AV block as detected by ECG to detect HGAVB (as detected by ECG, cardiac telemetry or implantable loop recorder).
Timepoint [8] 403183 0
immediately prior, immediately post, 4 hours post and 24 hours post TAVI
Secondary outcome [9] 403184 0
Primary Outcome:
The sensitivity, specificity, positive predictive value and negative predictive value of AV Wenckebach as detected by ECG to detect HGAVB (as detected by ECG, cardiac telemetry or implantable loop recorder).
Timepoint [9] 403184 0
immediately prior, immediately post, 4 hours post and 24 hours post TAVI
Secondary outcome [10] 403185 0
Primary Outcome:
The sensitivity, specificity, positive predictive value and negative predictive value of atrial fibrillation as detected by ECG to detect HGAVB (as detected by ECG, cardiac telemetry or implantable loop recorder).
Timepoint [10] 403185 0
immediately prior, immediately post, 4 hours post and 24 hours post TAVI
Secondary outcome [11] 403186 0
Primary Outcome:
The sensitivity, specificity, positive predictive value and negative predictive value of atrial flutter as detected by ECG to detect HGAVB (as detected by ECG, cardiac telemetry or implantable loop recorder).
Timepoint [11] 403186 0
immediately prior, immediately post, 4 hours post and 24 hours post TAVI
Secondary outcome [12] 403187 0
The area under the receiver operating characteristic curve (AUC) for the change in AV Wenkebach cycle length after TAVI (ms) as a predictor for HGAVB after TAVI (as detected by ECG, cardiac telemetry or implantable loop recorder)
Timepoint [12] 403187 0
TAVI Admission, 28 days, 6 months, 12 months, 24 months
Secondary outcome [13] 403188 0
The area under the receiver operating characteristic curve (AUC) for the percentage change in AV Wenkebach cycle length after TAVI (%) as a predictor for HGAVB after TAVI (as detected by ECG, cardiac telemetry or implantable loop recorder)
Timepoint [13] 403188 0
TAVI Admission, 28 days, 6 months, 12 months, 24 months
Secondary outcome [14] 403189 0
The area under the receiver operating characteristic curve (AUC) for the change in HV interval after TAVI (ms) as a predictor for HGAVB after TAVI (as detected by ECG, cardiac telemetry or implantable loop recorder)
Timepoint [14] 403189 0
TAVI Admission, 28 days, 6 months, 12 months, 24 months
Secondary outcome [15] 403190 0
The area under the receiver operating characteristic curve (AUC) for the AV Wenkebach cycle length after TAVI (ms) as a predictor for HGAVB after TAVI (as detected by ECG, cardiac telemetry or implantable loop recorder)
Timepoint [15] 403190 0
TAVI Admission, 28 days, 6 months, 12 months, 24 months
Secondary outcome [16] 403191 0
The area under the receiver operating characteristic curve (AUC) for the AV Wenkebach cycle length prior to TAVI (ms) as a predictor for HGAVB after TAVI (as detected by ECG, cardiac telemetry or implantable loop recorder)
Timepoint [16] 403191 0
TAVI Admission, 28 days, 6 months, 12 months, 24 months
Secondary outcome [17] 403192 0
The area under the receiver operating characteristic curve (AUC) for the HV interval after TAVI (ms) as a predictor for HGAVB after TAVI (as detected by ECG, cardiac telemetry or implantable loop recorder)
Timepoint [17] 403192 0
TAVI Admission, 28 days, 6 months, 12 months, 24 months
Secondary outcome [18] 404102 0
The area under the receiver operating characteristic curve (AUC) for the HV interval before TAVI (ms) as a predictor for HGAVB after TAVI (as detected by ECG, cardiac telemetry or implantable loop recorder)
Timepoint [18] 404102 0
TAVI Admission, 28 days, 6 months, 12 months, 24 months
Secondary outcome [19] 404103 0
The area under the receiver operating characteristic curve (AUC) for the Noncoronary cusp device-landing zone calcium volume (NCC-DLZ CA) (mm3) as a predictor for HGAVB after TAVI (as detected by ECG, cardiac telemetry or implantable loop recorder)
Timepoint [19] 404103 0
TAVI Admission, 28 days, 6 months, 12 months, 24 months
Secondary outcome [20] 404104 0
The area under the receiver operating characteristic curve (AUC) for the Membranous septum length (mm) as a predictor for HGAVB after TAVI (as detected by ECG, cardiac telemetry or implantable loop recorder)
Timepoint [20] 404104 0
TAVI Admission, 28 days, 6 months, 12 months, 24 months
Secondary outcome [21] 404105 0
The area under the receiver operating characteristic curve (AUC) for the difference between membranous septum length and implantation depth (mm) as a predictor for HGAVB after TAVI (as detected by ECG, cardiac telemetry or implantable loop recorder)
Timepoint [21] 404105 0
TAVI Admission, 28 days, 6 months, 12 months, 24 months
Secondary outcome [22] 404106 0
The area under the receiver operating characteristic curve (AUC) for Implantation depth (mm) as a predictor for HGAVB after TAVI (as detected by ECG, cardiac telemetry or implantable loop recorder)
Timepoint [22] 404106 0
TAVI Admission, 28 days, 6 months, 12 months, 24 months
Secondary outcome [23] 404107 0
The area under the receiver operating characteristic curve (AUC) for Cover index as a predictor for HGAVB after TAVI (as detected by ECG, cardiac telemetry or implantable loop recorder)
Timepoint [23] 404107 0
TAVI Admission, 28 days, 6 months, 12 months, 24 months
Secondary outcome [24] 404108 0
The proportion of patients that develop delayed HGAVB after TAVI (as detected by ECG, cardiac telemetry or implantable loop recorder)
Timepoint [24] 404108 0
48 hours, 72 hours, 7 days, 28 days, 6 months, 12 months, 24 months
Secondary outcome [25] 404109 0
The proportion of patients that develop new atrial fibrillation or flutter after TAVI (as detected by ECG, cardiac telemetry or implantable loop recorder)
Timepoint [25] 404109 0
28 days, 6 months, 12 months, 24 months

Eligibility
Key inclusion criteria
1. Age >= 18 years
2. Undergoing elective TAVI and have a scheduled date
3. Willingness to give written informed consent
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Permanent Pacemaker
2. Valve-in-valve TAVI

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
For each pre-specified predictor in the primary outcome, the following outcomes will be calculated (where: TP = True positive; FP = False positive; TN = True negative; FN = False negative)
Sensitivity = TP / (TP+FN)
Specificity = TN / (TN + FP)
Positive Predictive Value = TP/(TP+FP)
Negative Predictive Value = TN/(TN+FN)

A sample size of 194 produces a two-sided 95% confidence interval with a width equal to 0.15 when the sample sensitivity is 0.98 and the prevalence is 0.15 (Wilson score interval). Assuming a dropout rate of 5%, a total enrolment sample size of 205 is required.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
26/10/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
205
Accrual to date
105
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 20807 0
Royal North Shore Hospital - St Leonards
Recruitment hospital [2] 20808 0
North Shore Private Hospital - St Leonards
Recruitment postcode(s) [1] 35627 0
2065 - St Leonards

Funding & Sponsors
Funding source category [1] 309959 0
Hospital
Name [1] 309959 0
Cardiology Department, Royal North Shore Hospital
Country [1] 309959 0
Australia
Primary sponsor type
Hospital
Name
Royal North Shore Hospital, Northern Sydney Local Health District
Address
Royal North Shore Hospital, Reserve Road, St Leonards, NSW 2065
Country
Australia
Secondary sponsor category [1] 311006 0
None
Name [1] 311006 0
Address [1] 311006 0
Country [1] 311006 0
Other collaborator category [1] 282026 0
Other Collaborative groups
Name [1] 282026 0
BIOTRONIK Australia Pty Ltd
Address [1] 282026 0
BIOTRONIK Australia Pty Ltd, Level 4, Building 2, 20 Bridge Street, Pymble, NSW 2073
Country [1] 282026 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309674 0
Northern Sydney Local Health District
Ethics committee address [1] 309674 0
Ethics committee country [1] 309674 0
Australia
Date submitted for ethics approval [1] 309674 0
Approval date [1] 309674 0
12/08/2021
Ethics approval number [1] 309674 0
2021/ETH01039

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 114994 0
Prof Ravinay Bhindi
Address 114994 0
Cardiology Department, Royal North Shore Hospital, Reserve Road, St Leonards, NSW 2065
Country 114994 0
Australia
Phone 114994 0
+61 0299267111
Fax 114994 0
Email 114994 0
[email protected]
Contact person for public queries
Name 114995 0
Ravinay Bhindi
Address 114995 0
Cardiology Department, Royal North Shore Hospital, Reserve Road, St Leonards, NSW 2065
Country 114995 0
Australia
Phone 114995 0
+61 2 9926 7111
Fax 114995 0
Email 114995 0
[email protected]
Contact person for scientific queries
Name 114996 0
Ravinay Bhindi
Address 114996 0
Cardiology Department, Royal North Shore Hospital, Reserve Road, St Leonards, NSW 2065
Country 114996 0
Australia
Phone 114996 0
+61 2 9926 7111
Fax 114996 0
Email 114996 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Ethics application does not cover IPD sharing.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseProspective observational study on the accuracy of predictors of high-grade atrioventricular conduction block after transcatheter aortic valve implantation (CONDUCT-TAVI): study protocol, background and significance.2023https://dx.doi.org/10.1136/bmjopen-2022-070219
N.B. These documents automatically identified may not have been verified by the study sponsor.