Rate Adaptive Atrial Pacing in Heart Failure Patients with Chronotropic Incompetence

Rate Adaptive Atrial Pacing in Heart Failure Patients with Chronotropic Incompetence - ADAPTION Trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON47907

Enrollment

Registered

2019-09-17

Start date

2017-09-25

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

chronotropic incompetence

Interventions

In this study, the intervention is MV sensor driven rate adaptive atrial stimulation as previously described.

Chronotropic incompetence

Heart failure

Rate adaptive atrial pacing

Eligibility

Age

18 Years to 64 Years

Inclusion criteria

Inclusion criteria: - Chronotropic Incompetence - Implanted with a Boston Scientific dual chamber ICD or CRT-D equipped with Minute Ventilation sensor - Symptomatic congestive heart failure (NYHA class II-III) - Left ventricular systolic dysfunction (Ejection Fraction

Exclusion criteria

Exclusion criteria: - Age 5% per month in the last 3 months prior to inclusion - Indication for pacing (Sick Sinus Syndrome, atrioventricular conduction abnormalities requiring pacing) - Respiratory rate abnormalities (hyperventilation) or use of a mechanical ventilator - Patients who are unable to tolerate increased pacing rates - Beta-blokker / ivabradine / amiodarone therapy is not an exclusion criterion

Design outcomes

Primary

Measure	Time frame
The primary endpoint of the study is improvement of quality of life in CI heart failure patients. QoL questionnaire score with and without rate adaptive atrial pacing using the MV sensor will be compared. A 10% improvement in QoL score by rate responsive pacing is considered a significant improvement. Please refer to chapter 6.1 of the protocol (study parameters/endpoints)	—

Secondary

Measure	Time frame
Secondary outcome of the study is: 1. Improvement of functional capacity in CI heart failure patients. 6MWT with and without rate adaptive atrial pacing using the MV sensor will be compared. A 10% improvement in 6MWT is considered a significant improvement. 2. Reversibility of CI by rate adaptive atrial pacing using a MV sensor will be assessed by comparison of the mHRS with and without rate adaptive pacing. The change in mHRS will be correlated to the change in functional capacity, activity level and quality of life. 3. Clinical status and daily activity level will be evaluated by assessment of NYHA score and activity score measured by the device*s accelerometer, and will be compared with and without rate adaptive pacing. Please refer to chapter 6.1 of the protocol (study parameters/endpoints)	—

Measure

Time frame

Secondary outcome of the study is: 1. Improvement of functional capacity in CI heart failure patients. 6MWT with and without rate adaptive atrial pacing using the MV sensor will be compared. A 10% improvement in 6MWT is considered a significant improvement. 2. Reversibility of CI by rate adaptive atrial pacing using a MV sensor will be assessed by comparison of the mHRS with and without rate adaptive pacing. The change in mHRS will be correlated to the change in functional capacity, activity level and quality of life. 3. Clinical status and daily activity level will be evaluated by assessment of NYHA score and activity score measured by the device*s accelerometer, and will be compared with and without rate adaptive pacing. Please refer to chapter 6.1 of the protocol (study parameters/endpoints)

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Countries

The Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)