July 4, 2017TrialsOpen Access

Prior balloon valvuloplasty versus DIRECT transcatheter Aortic Valve Implantation (DIRECTAVI): study protocol for a randomized controlled trial

Q: What is the clinical evidence from this study?

Study design: RCT. Population: Severe symptomatic aortic stenosis (n=240). Intervention: Direct transcatheter aortic valve implantation (without prior balloon dilatation) vs. Transcatheter aortic valve implantation with prior balloon aortic valvuloplasty. Primary outcome: Immediate procedural success (absence of immediate procedural mortality, correct positioning, intended performance, and no moderate/severe regurgitation).

Q: What does this research mean for the field?

The DIRECTAVI randomized controlled trial is designed to evaluate whether direct transcatheter aortic valve implantation without prior balloon dilatation is noninferior to the standard procedure with predilatation. Novelty: ClaimNovelty.METHODOLOGICAL. Consensus alignment: ConsensusAlignment.NEUTRAL.

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Key result

New RCT protocol tests if direct TAVI without predilatation is noninferior to standard TAVI.

n=240

Why the study?

Balloon predilatation during TAVI has been considered essential, but recent evidence suggests it may cause complications and might be unnecessary with new-generation valves.

Does direct transcatheter aortic valve implantation without prior balloon dilatation improve immediate procedural success compared to TAVI with prior balloon valvuloplasty in patients with an indication for TAVI?

Population

240 patients with indication for TAVI excluding transapical access

Comparison

TAVI with prior balloon valvuloplasty vs direct TAVI without predilatation

Design

Randomized controlled open-label trial

Follow-up

30-day

Authors

FLFlorence Leclercq PRPierre Robert JLJessica Labour

Discussion

Member takes

Overview

RCT protocol tests noninferiority of direct TAVI; leaves open whether predilatation can be omitted.

Study Design

Type

RCT (n=240)

Blinding

Open-label

Randomization

1:1 ratio and permuted blocks of 4 and 6

Multicenter

Structured PICO

Population

A planned cohort of 240 adult patients with severe symptomatic aortic stenosis at high surgical risk, scheduled to undergo TAVI with the SAPIEN 3 valve.

Intervention

Direct transcatheter aortic valve implantation (TAVI) without prior balloon dilatation using new-generation balloon-expandable SAPIEN 3 valve.

Comparator

Transcatheter aortic valve implantation (TAVI) performed with prior balloon valvuloplasty (predilatation).

Outcome

Immediate procedural success.composite

This study protocol outlines a randomized controlled trial to determine if direct TAVI without prior balloon predilatation is noninferior to the standard approach with predilatation.

Limitations

Monocentric design may limit generalizability
Open-label design as investigators cannot be blinded to the procedure

Cite This Study

Leclercq et al. (2017) conducted an RCT in Severe symptomatic aortic stenosis (n=240). Direct transcatheter aortic valve implantation (without prior balloon dilatation) vs. Transcatheter aortic valve implantation with prior balloon aortic valvuloplasty was evaluated on Immediate procedural success (absence of immediate procedural mortality, correct positioning, intended performance, and no moderate/severe regurgitation). This study protocol describes a randomized controlled trial designed to evaluate whether direct transcatheter aortic valve implantation without prior balloon dilatation is noninferior to the standard approach with predilatation.

synapsesocial.com/papers/6aacbe61356d077555b0daba https://doi.org/10.1186/s13063-017-2036-y

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July 4, 2017TrialsOpen Access

Prior balloon valvuloplasty versus DIRECT transcatheter Aortic Valve Implantation (DIRECTAVI): study protocol for a randomized controlled trial

View Full Paper

Ask AI

Bookmark

Key result

New RCT protocol tests if direct TAVI without predilatation is noninferior to standard TAVI.

n=240

Why the study?

Balloon predilatation during TAVI has been considered essential, but recent evidence suggests it may cause complications and might be unnecessary with new-generation valves.

Population

240 patients with indication for TAVI excluding transapical access

Comparison

TAVI with prior balloon valvuloplasty vs direct TAVI without predilatation

Design

Randomized controlled open-label trial

Follow-up

30-day

Authors

FLFlorence Leclercq PRPierre Robert JLJessica Labour

Discussion

Member takes

Overview

RCT protocol tests noninferiority of direct TAVI; leaves open whether predilatation can be omitted.

Study Design

Type

RCT (n=240)

Blinding

Open-label

Randomization

1:1 ratio and permuted blocks of 4 and 6

Multicenter

Structured PICO

Population

A planned cohort of 240 adult patients with severe symptomatic aortic stenosis at high surgical risk, scheduled to undergo TAVI with the SAPIEN 3 valve.

Intervention

Direct transcatheter aortic valve implantation (TAVI) without prior balloon dilatation using new-generation balloon-expandable SAPIEN 3 valve.

Comparator

Transcatheter aortic valve implantation (TAVI) performed with prior balloon valvuloplasty (predilatation).

Outcome

Immediate procedural success.composite

This study protocol outlines a randomized controlled trial to determine if direct TAVI without prior balloon predilatation is noninferior to the standard approach with predilatation.

Limitations

Monocentric design may limit generalizability
Open-label design as investigators cannot be blinded to the procedure

Cite This Study

synapsesocial.com/papers/6aacbe61356d077555b0daba https://doi.org/10.1186/s13063-017-2036-y

Also Consider

Synapse has enriched 5 closely related papers on similar clinical questions. Consider them for comparative context:

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