# Continued Access Protocol for the Evaluation of the OPTIMIZER Smart System

> **NCT03102437** · NA · TERMINATED · sponsor: **Impulse Dynamics** · enrollment: 106 (actual)

## Conditions studied

- Heart Failure
- Congestive Heart Failure
- Chronic Heart Disease
- CHF

## Interventions

- **DEVICE:** Optimizer Smart System

## Key facts

- **NCT ID:** NCT03102437
- **Lead sponsor:** Impulse Dynamics
- **Sponsor class:** INDUSTRY
- **Phase:** NA
- **Study type:** INTERVENTIONAL
- **Status:** TERMINATED
- **Start date:** 2017-07-01
- **Primary completion:** 2019-12-16
- **Final completion:** 2019-12-16
- **Target enrollment:** 106 (ACTUAL)
- **Why stopped:** The primary objective of the protocol was to allow ongoing access to treatment of patients suffering from moderate to severe heart failure at selected investigational sites until the PMA was approved by the FDA for the OPTIMIZER System.
- **Last updated:** 2021-11-23


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT03102437

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT03102437, "Continued Access Protocol for the Evaluation of the OPTIMIZER Smart System". Retrieved via AI Analytics 2026-05-26 from https://api.ai-analytics.org/clinical/NCT03102437. Licensed CC0.

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