Ignite Creation Date:
2024-05-06 @ 7:55 PM
Last Modification Date:
2024-10-26 @ 3:17 PM
Study NCT ID:
NCT06189976
Status:
RECRUITING
Last Update Posted:
2024-04-15
First Post:
2023-12-17
Brief Title:
Rapid Atrial Pacing After TAVI to Predict Pacemaker Implantation
Sponsor:
National and Kapodistrian University of Athens
Organization:
National and Kapodistrian University of Athens
Study Overview
Official Title:
Rapid Atrial Pacing After TAVI as a Predictor of Permanent Pacemaker Implantation
Status:
RECRUITING
Status Verified Date:
2024-04
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:
None
Brief Summary:
Despite Transcatheter aortic valve implantation TAVI evolution regarding techniques equipment and experience the need for permanent pacemaker implantation PPI post-TAVI remains an important drawback The electrophysiology testing to stratify the risk or necessity of PPI post-TAVI is endorsed by the up-to-date guidelines and consensus documents and it is a valuable cut-off based method Part of the answer is maybe hidden in the easy and applicable testing of the atrioventricular conduction system through rapid atrial pacing RAP with a common temporary pacemaker lead This trial is designed to investigate the role and value of RAP after TAVI as a predictor of the necessity of new PPI
Detailed Description:
1 INTRODUCTION AND RATIONALE Despite Transcatheter aortic valve implantation TAVI evolution regarding techniques equipment and experience the need for permanent pacemaker implantation PPI post-TAVI remains an important drawback PPI rates range widely from 78 to 203 based on the CENTER collaboration results whereas significant differences are observed among the available devices Except for hospitalization prolongation and higher costs the impact of PPI in long term follow-ups seems to not to be innocent as it is associated with increased all-cause mortality and rehospitalization rates according to a recent meta-analysis Data from the SWEEDHEART registry demonstrated no difference in survival in a median follow-up of 27 years however as TAVI is offered to younger patients the long-term impact of PPI needs to be thoroughly investigated
The electrophysiology testing to stratify the risk or necessity of PPI post-TAVI is endorsed by the up-to-date guidelines and consensus documents and it is a valuable cut-off based method Despite individualization is essential thresholds provide added security and aid on final decisions Variable HV intervals have been evaluated in clinical trials 70ms is supported by ESC guidelines while 55 in the presence of left bundle branch block in an observational trial HV interval measurement seems appealing but there is lack of cut-off consensus not every Cath lab is equipped with electrophysiologic test equipment and TAVI operators are not generally familiar with these procedures
Part of the answer is maybe hidden in the easy and applicable testing of the atrioventricular conduction system through rapid atrial pacing RAP with a common temporary pacemaker lead Krishnaswamy et al performed post-TAVI atrial pacing from 70 to 120 beatsmin in 284 patients and concluded that those who did not develop pacing-induced Wenckebach atrioventricular block exhibited very low probability of PPI On the contrary a recent report from Tan et al found that atrial pacing-induced Wenckebach pre or post-TAVI in a total of 253 patients did not predict PPI In this trial balloon expandable valves were used that are associated with lower rates of PPI and it is possible that larger sample size is needed for safe conclusions
2 STUDY PROCEDURES TAVI will be planned to be performed with a temporary pacemaker lead in the right ventricle as a back-up for high grade conduction abnormalities orand for on demand pacing After a successful TAVI procedure if the patient is stable and not pacemaker-dependant the temporary pacemaker electrode will be placed into the right atrium This manoeuvre adds no cost and no additional risk for the patient as the electrode is already placed in the right chambers Surface electrocardiogram will be recorded at the whole procedure Atrial pacing will be initiated till Wenckebach AV block is observed and recorded or till the maximum atrial pacing rate is reached The rate that AV block was observed will be catalogued Maximum atrial pacing rate will be 150 beatsmin cycle length 400ms Patients enrolled and underwent TAVI will receive standard post-TAVI care in each centre as per local practice
3 STUDY MONITORING 31 Responsibility of the investigators The investigators undertake to perform the study in accordance with this protocol and GCP For the trial duration the investigators will maintain complete and accurate documentation including - but not limited to - medical records trial progress records laboratory reports case report forms signed informed consent forms device accountability records correspondence with the IRB adverse event reports and information regarding patient discontinuation or completion of the trial
32 Case report forms It is the responsibility of the investigator to maintain an accurate CRF to record all observations and other data pertinent to the clinical and laboratory investigations All CRF should be completed in their entirety in a neat legible manner to ensure accurate interpretation of data The data may be recorded either on hard copies or electronic data capture This data will be monitored by and forwarded to the primary investigator PI in an expedited fashion
4 ADVERSE EVENTS All events will be registered in the CRF as defined by GCP Adverse events will be actively checked during follow-up Patient folder will provide contact information for patients in case of questions and when complications occur Any complication will be managed at each centre per local practice
The electrophysiology testing to stratify the risk or necessity of PPI post-TAVI is endorsed by the up-to-date guidelines and consensus documents and it is a valuable cut-off based method Despite individualization is essential thresholds provide added security and aid on final decisions Variable HV intervals have been evaluated in clinical trials 70ms is supported by ESC guidelines while 55 in the presence of left bundle branch block in an observational trial HV interval measurement seems appealing but there is lack of cut-off consensus not every Cath lab is equipped with electrophysiologic test equipment and TAVI operators are not generally familiar with these procedures
Part of the answer is maybe hidden in the easy and applicable testing of the atrioventricular conduction system through rapid atrial pacing RAP with a common temporary pacemaker lead Krishnaswamy et al performed post-TAVI atrial pacing from 70 to 120 beatsmin in 284 patients and concluded that those who did not develop pacing-induced Wenckebach atrioventricular block exhibited very low probability of PPI On the contrary a recent report from Tan et al found that atrial pacing-induced Wenckebach pre or post-TAVI in a total of 253 patients did not predict PPI In this trial balloon expandable valves were used that are associated with lower rates of PPI and it is possible that larger sample size is needed for safe conclusions
2 STUDY PROCEDURES TAVI will be planned to be performed with a temporary pacemaker lead in the right ventricle as a back-up for high grade conduction abnormalities orand for on demand pacing After a successful TAVI procedure if the patient is stable and not pacemaker-dependant the temporary pacemaker electrode will be placed into the right atrium This manoeuvre adds no cost and no additional risk for the patient as the electrode is already placed in the right chambers Surface electrocardiogram will be recorded at the whole procedure Atrial pacing will be initiated till Wenckebach AV block is observed and recorded or till the maximum atrial pacing rate is reached The rate that AV block was observed will be catalogued Maximum atrial pacing rate will be 150 beatsmin cycle length 400ms Patients enrolled and underwent TAVI will receive standard post-TAVI care in each centre as per local practice
3 STUDY MONITORING 31 Responsibility of the investigators The investigators undertake to perform the study in accordance with this protocol and GCP For the trial duration the investigators will maintain complete and accurate documentation including - but not limited to - medical records trial progress records laboratory reports case report forms signed informed consent forms device accountability records correspondence with the IRB adverse event reports and information regarding patient discontinuation or completion of the trial
32 Case report forms It is the responsibility of the investigator to maintain an accurate CRF to record all observations and other data pertinent to the clinical and laboratory investigations All CRF should be completed in their entirety in a neat legible manner to ensure accurate interpretation of data The data may be recorded either on hard copies or electronic data capture This data will be monitored by and forwarded to the primary investigator PI in an expedited fashion
4 ADVERSE EVENTS All events will be registered in the CRF as defined by GCP Adverse events will be actively checked during follow-up Patient folder will provide contact information for patients in case of questions and when complications occur Any complication will be managed at each centre per local practice
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None