Cardiac Resynchronisation Therapy in Combination With Overdrive Pacing in the Treatment of Central Sleep Apnea in CHF

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT00551499
• Date of registration: 30/10/2007
• Primary sponsor: Medtronic Bakken Research Center
• Public title: Cardiac Resynchronisation Therapy in Combination With Overdrive Pacing in the Treatment of Central Sleep Apnea in CHF Morpheus
• Scientific title: Cardiac Resynchronisation Therapy in Combination With Overdrive Pacing in the Treatment of Central Sleep Apnea in CHF
• Date of first enrolment: June 2005
• Target sample size: 44
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00551499
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Countries of recruitment

Germany

Contacts

• Name: S Andreas, Prof. Dr
• Affiliation: Georg-August-Universität, Göttingen, Department of Cardiology and Pneumology, Robert-Koch Str. 40, 37075 Göttingen, Germany

Key inclusion & exclusion criteria

Inclusion Criteria:

- Patients with documented clinical history of symptomatic but stable congestive heart
failure, NYHA III or NYHA IV, of at least six weeks duration.

- Patient has an indication for a CRT device, or patients with previous pacemaker
indication, except Sick Sinus Syndrome, and currently in need for an upgrade to a CRT
device

- Patient is scheduled for the implantation of a CRT device

- Patient is over 18 years of age

- Patient provides Informed Consent

Exclusion Criteria:

- Inability to complete overnight sleep study as specified by the protocol

- Myocardial infarction or coronary revascularization procedure within 2 calendar
months prior to enrollment

- Planned or strong likelihood of cardiac surgery within 4 months following enrollment

- A spirometric confirmation of obstructive lung disease

- Evidence of obstructive sleep apnea at baseline polysomnography

- Body mass index >30 kg/m²

- Pregnant women



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Central Sleep Apnea

Heart Failure

Intervention(s)

Device: CRT in combination with Atrial Overdrive Pacing

Primary Outcome(s)

To demonstrate that a single night of overdrive pacing applied after 12 weeks of cardiac resynchronization therapy in comparison to cardiac resynchronization alone will improve sleep apnea as measured by Apnea- hypopnea- index (AHI) [Time Frame: 12 weeks]

Secondary Outcome(s)

To evaluate the effects of nocturnal overdrive pacing applied after 12 weeks of CRT vs. CRT alone on breathing events, sleeping events, neurohormonal markers, QoL, LVEF, exercise parameters and NYHA, [Time Frame: 12 weeks]

Secondary ID(s)

113

Source(s) of Monetary Support

Please refer to primary and secondary sponsors