Ignite Creation Date:
2024-06-16 @ 11:51 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06445439
Status:
RECRUITING
Last Update Posted:
2024-06-06
First Post:
2024-03-25
Brief Title:
Optimal Pacing Rate for Cardiac Resynchronization Therapy
Sponsor:
Medstar Health Research Institute
Organization:
Medstar Health Research Institute
Study Overview
Official Title:
Optimal Pacing Rate for Cardiac Resynchronization Therapy After Atrioventricular Node Ablation in Persistent Atrial Fibrillation and Heart Failure
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
OPT-RATE AF
Brief Summary:
This is a prospective randomized crossover study The objective of the study is to determine if a pacing rate of 80 beats per minute bpm improves exercise tolerance during the 6-minute walk test The investigators will randomly assign half of the participants to a starting rate of 60 bpm and then switch them to a rate of 80 bpm for 3 months and vice versa
Detailed Description:
Cardiac resynchronization therapy CRT after atrioventricular node AVN ablation for permanent atrial fibrillation AF has led to better outcomes in heart failure HF patients with reduced ejection fraction HFrEF and with preserved ejection fraction HFpEF compared to pharmacotherapy Emerging evidence has demonstrated patients with HFpEF may benefit from a higher heart rate compared to standard heart-lowering therapies The optimal pacing rate for CRT after AVN ablation in persistent AF and HFpEF remains unknown
This is a prospective randomized crossover study The objective of the study is to determine if a pacing rate of 80 beats per minute bpm improves exercise tolerance during the 6-minute walk test
The investigators will randomly assign half of the participants to a starting rate of 60 bpm and then switch them to a rate of 80 bpm for 3 months and vice versa Patient mortality and HF hospitalizations will be recorded at each phase An electrocardiogram echocardiogram pacemaker interrogation BNP and creatinine levels KCCQ-12 six-minute walk test and physical activity measure will be obtained at baseline 3 months and 6 months
This is a prospective randomized crossover study The objective of the study is to determine if a pacing rate of 80 beats per minute bpm improves exercise tolerance during the 6-minute walk test
The investigators will randomly assign half of the participants to a starting rate of 60 bpm and then switch them to a rate of 80 bpm for 3 months and vice versa Patient mortality and HF hospitalizations will be recorded at each phase An electrocardiogram echocardiogram pacemaker interrogation BNP and creatinine levels KCCQ-12 six-minute walk test and physical activity measure will be obtained at baseline 3 months and 6 months
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None