What does this research mean for the field?

The PROVIDE trial is designed to evaluate whether a pre-selected combination of ICD programming parameters prolongs the mean time to first shock without increasing arrhythmic syncope in patients receiving ICDs for primary prevention. Novelty: ClaimNovelty.METHODOLOGICAL. Consensus alignment: ConsensusAlignment.NEUTRAL.

What question did this study set out to answer?

To assess whether optimized arrhythmia detection, anti-tachycardia pacing, and supraventricular tachycardia discrimination parameters extend the time to first shock without raising arrhythmic syncope risk in primary prevention ICD and CRT-D recipients.

July 21, 2011EP EuropaceOpen Access

Rationale and design for programming implantable cardioverter-defibrillators in patients with primary prevention indication to prolong time to first shock (PROVIDE) study

Q: What is the clinical evidence from this study?

Study design: RCT. Population: Primary prevention indication for ICD or CRT-D (n=1600). Intervention: Pre-selected combination of programming parameters (ventricular tachyarrhythmia detection, anti-tachycardia pacing, and SVT discriminator) vs. Alternative arrhythmia detection and therapy approach. Primary outcome: Mean time to first shock.

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Key result

A pre-selected combination of ICD programming parameters will be evaluated in the PROVIDE trial (N=1600) to determine if it prolongs the mean time to first shock compared to an alternative approach.

Why the study?

Does a pre-selected combination of programming parameters prolong time to first shock in patients receiving ICDs/CRT-Ds for primary prevention?

Population

1600 patients receiving St Jude Medical implantable cardioverter-defibrillators and cardiac…

Comparison

Pre-selected combination of ventricular… vs Alternative arrhythmia detection and therapy…

Design

Other, 1:1

Follow-up

At least 1 year or until 226 first shocks have been…

Authors

MSMohammad SaeedVirginia Commonwealth University MRMehdi RazaviAmerican Heart Association CNCURTIS NEASONSt. Jude Medical Center

Discussion

Member takes

Implication

Time to first shock with pre-selected ICD programming remains unproven in primary prevention; PROVIDE leaves this hypothesis open.

Key Points

To assess whether optimized arrhythmia detection, anti-tachycardia pacing, and supraventricular tachycardia discrimination parameters extend the time to first shock without raising arrhythmic syncope risk in primary prevention ICD and CRT-D recipients.
Prospective, multicenter, randomized controlled trial enrolling 1,600 primary prevention patients receiving St. Jude Medical ICDs or CRT-Ds.
Participants are randomized 1:1 to standard versus tailored arrhythmia detection and therapy programming approaches and monitored for at least 1 year or until 226 first shocks occur across the cohort.
Primary efficacy evaluation is designed to measure the mean time to first delivered shock between the two programming strategies.
Safety monitoring protocol focuses on comparing the incidence and rates of arrhythmic syncope between study arms.

Study Design

Type

RCT (n=1,600)

Randomization

1:1

Multicenter

Yes

Structured PICO

Does a pre-selected combination of programming parameters prolong time to first shock in patients receiving ICDs/CRT-Ds for primary prevention?

Population

1600 patients receiving St Jude Medical implantable cardioverter-defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) for primary prevention

Intervention

Pre-selected combination of ventricular tachyarrhythmia detection, anti-tachycardia pacing, and SVT discriminator parameters

Comparator

Alternative arrhythmia detection and therapy approach

Outcome

Mean time to first shockhard clinical

The PROVIDE study is designed to evaluate whether specific ICD/CRT-D programming parameters can safely prolong the time to first shock in primary prevention patients.

Cite This Study

Saeed et al. (2011) conducted an RCT in Primary prevention indication for ICD or CRT-D (n=1,600). Pre-selected combination of programming parameters (ventricular tachyarrhythmia detection, anti-tachycardia pacing, and SVT discriminator) vs. Alternative arrhythmia detection and therapy approach was evaluated on Mean time to first shock. A pre-selected combination of ICD programming parameters will be evaluated in the PROVIDE trial (N=1600) to determine if it prolongs the mean time to first shock compared to an alternative approach.

synapsesocial.com/papers/6a1921920b4377da6557de12 https://doi.org/10.1093/europace/eur195

Topics

Cardiac device therapy

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Rationale and design for programming implantable cardioverter-defibrillators in patients with primary prevention indication to prolong time to first shock (PROVIDE) study

Discussion

Member takes

Implication

Key Points

Study Design

Structured PICO

Cite This Study

Topics

Rationale and design for programming implantable cardioverter-defibrillators in patients with primary prevention indication to prolong time to first shock (PROVIDE) study

Discussion

Member takes

Implication

Key Points

Study Design

Structured PICO

Cite This Study

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