Specialized Pacing for Patients With Congenital Heart Disease
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03361189|
Recruitment Status : Not yet recruiting
First Posted : December 4, 2017
Last Update Posted : April 23, 2019
|Condition or disease||Intervention/treatment||Phase|
|Congenital Heart Disease Bradycardia Sinus||Device: Closed loop stimulation||Phase 2 Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||18 participants|
|Intervention Model:||Crossover Assignment|
|Intervention Model Description:||
Patient Enrollment: The treating physician will identify potential subjects with a previously implanted pacemaker and present a brief overview of the study. Informed consent will be obtained by the investigator after discussing the study, including the voluntary nature of participation and notification the subject can withdraw at any time. The investigator will give the subject and his/her legal guardian the opportunity to take the consent home to think about it more, with the option to call or meet with the investigator to ask additional questions. If the subject and/or his/her parent/legal guardian agree to participate, the investigator will ask them to sign a written, informed consent and assent.
Randomization Procedure: This will be a single-blind placebo-controlled randomized crossover study with 2 treatments: CLS-on versus CLS-off (accelerometer only). Each enrolled patient will receive both treatments for 3 months. The order of treatments will be randomized 1:1.
|Masking:||Double (Participant, Outcomes Assessor)|
|Official Title:||A Randomized Trial of Closed Loop Stimulation After Epicardial Pacemaker Implantation for Congenital Heart Disease|
|Estimated Study Start Date :||January 1, 2020|
|Estimated Primary Completion Date :||February 1, 2023|
|Estimated Study Completion Date :||August 1, 2023|
Subjects in this arm will programmed to CLS-on to received closed loop stimulation-based pacing.
Device: Closed loop stimulation
Closed loop stimulation is a physiologic, rate-adaptive pacing algorithm.
No Intervention: CLS-Off
Subjects in this arm, will be placed in a standard pacing mode (i.e. AAIR or DDDR).
- Heart rate response [ Time Frame: 3 months ]Heart rate in response to mental stress and autonomic input will be asssessed
- Oxygen uptake [ Time Frame: 3 months ]Oxygen uptake will be determined by cardiopulmonary gas exchange
- Quality of life [ Time Frame: 3 months ]Quality of life will be assessed by SF-36 questionnaire
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03361189
|Contact: Jeremy P Moore, MD, MSfirstname.lastname@example.org|
|Contact: Kevin M Shannon, MDemail@example.com|